JJOD 2406 1–7 journal of dentistry xxx (2015) xxx–xxx
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.intl.elsevierhealth.com/journals/jden 1 2 3
Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial
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Q1
Cristiane da Mata a,*, P. Finbarr Allen a, Gerald McKenna b, Michael Cronin c, Denis O’Mahony d, Noel Woods e a
Cork University Dental School and Hospital, University College Cork, Ireland
b
Q2 Centre for Dentistry, Queens University Belfast, Northern Ireland, United Kingdom c
School of Mathematical Sciences, University College Cork, Ireland School of Medicine, University College Cork, Ireland e Centre for Policy Studies, University College Cork, Ireland d
article info
abstract
Article history:
Objectives: Older dentate adults are a high caries risk group who could potentially benefit
Received 9 November 2014
from the use of the atraumatic restorative treatment (ART). This study aimed to compare the
Received in revised form
survival of ART and a conventional restorative technique (CT) using rotary instruments and
1 January 2015
a resin-modified glass-ionomer for restoring carious lesions as part of a preventive and
Accepted 7 January 2015
restorative programme for older adults after 2 years.
Available online xxx
Methods: In this randomised controlled clinical trial, 99 independently living adults
Keywords:
conventional restorations. The survival of restorations was assessed by an independent
(65–90 years) with carious lesions were randomly allocated to receive either ART or Atraumatic restorative treatment
and blinded examiner 6 months, 1 year and 2 years after restoration placement.
Elderly
Results: Ninety-six (67.6%) and 121 (76.6%) restorations were assessed in the ART and CT
Caries
groups, respectively, after 2 years. The cumulative restoration survival percentages after
Partially dentate
2 years were 85.4% in the ART and 90.9% in the CT group. No statistically significant between group differences were detected (p = 0.2050, logistic regression analysis). Conclusions: In terms of restoration survival, ART was as effective as a conventional restorative approach to treat older adults after 2 years. This technique could be a useful tool to provide dental care for older adults particularly in the non-clinical setting. (Trial Registration number: ISRCTN 76299321). Clinical Significance: The results of this study show that ART presented survival rates similar to conventional restorations in older adults. ART appears to be a cost-effective way to provide dental care to elderly patients, particularly in out of surgery facilities, such as nursing homes. # 2015 Published by Elsevier Ltd.
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* Corresponding author. Tel.: +353 021 420 1100; fax: +353 021 490 1193. E-mail address: [email protected] (C. da Mata). http://dx.doi.org/10.1016/j.jdent.2015.01.003 0300-5712/# 2015 Published by Elsevier Ltd.
Please cite this article in press as: da Mata C, et al. Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial. Journal of Dentistry (2015), http://dx.doi.org/10.1016/j.jdent.2015.01.003
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Q3 1.
Introduction
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2.
Materials and methods
2.1.
Study design
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Q4 Dental caries is a major public health problem in many
countries worldwide and despite all the advances in its diagnosis, prevention and treatment, untreated dental caries still has a high prevalence. According to a 2010 report, untreated dental caries in permanent teeth was the most prevalent condition evaluated by a study on the global burden of diseases, with a prevalence of 35% for all ages combined.1 Older patients are helping inflate these figures as the population around the globe is ageing rapidly and the global burden of oral conditions in older patients is shifting from complete tooth loss towards periodontitis and untreated caries.1 Furthermore, provision of oral healthcare to older adults is often inadequate and in developed countries, despite the availability of oral health services, dental uptake among older individuals can be very low.2–4 Conventional dental treatment might not be acceptable or accessible to older patients, particularly frail elderly or nursing home residents, and providing suitable and cost-effective dental treatment to this population can be challenging. Governments, policy makers and society in general need to address this problem, in order to improve elderly individuals’ oral health, and consequently their quality of life. Therefore, an alternative technique to restore carious teeth that could prove to be acceptable to elderly patients, cost-effective and easy to administer should be considered. The atraumatic restorative treatment (ART) approach could be such an option as studies suggest good restoration survival rates and patient acceptabiliy .5–8 A recent study has also demonstrated the cost-effectiveness of ART in the treatment of elderly patients compared to conventional approaches .9 However very few other studies have reported on the use of ART in the elderly, with small samples and short follow -up periods described.10–12 None of these previous reports include community-dwelling independent elderly adults, nor do they report medium to long term survival rates of ART compared to conventional techniques. ART was initially used as an alternative to treat caries in underserved communities where resources such as electricity, piped water, dental equipment and finance were rarely available .13 However, ART has potential applications in industrialised countries and seems to be a promising approach to treat elderly patients, especially homebound older adults and those living in nursing homes .14 This population has traditionally had limited access to routine dental care and consequently, are at a higher risk of developing caries .15 Twenty-five years after the results of the first pilot study, ART, as part of a Basic Package of Oral Care, has become an important cornerstone for the development of global oral health and for the minimisation of inequalities in oral care, particularly in vulnerable and underserved populations such as the elderly .16 The aim of this study was to compare the 2-year survival of restorations placed according to the principles of ART compared to conventional restorations in partially dentate older patients. The null hypothesis for the study stated that the survival of ART restorations would be no worse than those placed according to a conventional approach.
A randomised controlled clinical trial (Trial registration number: ISRCTN 76299321) was conducted using a parallel group design. The study protocol was submitted and given full ethical approval by the Clinical Ethics Committee of the Cork Teaching Hospitals (ECM 5 (4) 02/09/08). Each patient was provided with written information detailing the proposed treatment involved and each patient completed a written consent form prior to clinical examination.
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2.2.
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Recruitment
Partially dentate older patients (>65 years) were recruited from two centres: Cork University Dental Hospital (CUDH) and St Finbarr’s Geriatric Day Hospital (SFDH) in Cork, Ireland. Those patients in SFDH represented a more systemically unwell and older cohort as they attended the Geriatric Day Hospital to receive a range of medical treatments. Advertisements inviting patients to participate in the study were entered in the newsletter of a church near to CUDH for 6 months. The same advertisement was placed in the waiting areas of CUDH and SFDH. Contact details of the study coordinator were provided and patients were allocated appointments. All of the patients recruited to the study were independently living elderly with various levels of comorbidity.
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2.3.
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Clinical examination
Upon entering the study each patient received a clinical examination which charted hard tissues, periodontal condition, caries and number of occluding contacts. Each intra-oral examination was carried out by two calibrated dentists (interexaminer consistency kappa score = 0.88) who had received prior training by a gold standard examiner. Patients who met the inclusion criteria for the study were invited to participate and given a confidential trial identifier.
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2.4.
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Inclusion and exclusion criteria
The inclusion criteria for entering this study were: 65 years of age or older; presence of at least one dentinal carious lesion (coronal or root) with no painful symptomatology; and able to perform mechanical oral hygiene techniques including toothbrushing. Patients who presented with carious teeth with a history of pain, cavities resulting from attrition, erosion or abrasion, with no caries, and teeth with significant periodontal involvement (Grade III mobility), were excluded from the study.
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2.5.
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Randomisation
Patients were randomly allocated to two different treatment groups: the ART group and the conventional treatment (CT) group. Randomisation was performed using a computer generated schedule in SAS1. Patient randomisation was
Please cite this article in press as: da Mata C, et al. Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial. Journal of Dentistry (2015), http://dx.doi.org/10.1016/j.jdent.2015.01.003
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‘‘press-finger’’ technique whenever the type of cavity allowed. In the case of root restorations, a glove coated with petroleum jelly was used similarly to the ‘‘pressfinger’’ technique to better condense the material into the cavity. Excess material was removed with a carver after checking the occlusion and the restoration was coated with petroleum jelly. 2) The treatment protocol for those patients in the CT group consisted of provision of local anaesthesia, use of rotary instruments for access and removal of carious tissue, conditioning of the cavity with a polyacrylic acid for 20 s, washing and drying with cotton pellets and placement of a hand-mixed resin-modified glass-ionomer (GC Fuji II LCTM). Isolation was achieved using the procedure described for ART restorations. The restorative material was light-cured for 20 s and the restoration was polished with soflex discs after checking the occlusion. The final restoration was then coated with G-coat plus according to manufacturers’ instructions.
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conducted by a research assistant and the allocation was concealed from the clinical operator using sequentially numbered, opaque, sealed envelopes.
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2.6.
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A sample size calculation was performed in order to demonstrate non-inferiority of ART survival rate relative to conventional treatment after one year. The survival of conventional restorations was estimated to be 92.1% as shown in a previous study with a similar population.11 With a non-inferiority limit of 10% regarded as a clinically insignificant difference, a 5% significance level and a power of 80%, a sample size of 129 restorations per group was necessary, allowing for a 30% drop out rate. To ensure adequate power, an achieved sample size of 90 restorations per group was required at two-year followup.
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2.7.
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Each patient completed a questionnaire which recorded age, gender, place of residence (e.g., independently living, assisted by home help), general health, medical history (including xerostomia) and oral hygiene practices. Clinical examinations were performed, and details of carious lesions, restorations and teeth present were recorded. Plaque scores were recorded at baseline using the mucosal plaque score (MPS) index. The following criteria were used for the detection and classification of root caries: 1 – colour (light/dark brown/black); 2 – texture (smooth, rough); 3 – appearance (shiny or glossy, matte or non-glossy); 4 – perception on gentle probing (soft, leathery, hard); and 5 – cavitation (loss of anatomical contour). A caries code was given when the lesion was yellowish/light brown, with a rough texture, and appeared non-glossy and soft or leathery to probing.
Patients were reviewed 6 months, 1 year and 2 years after the restorations had been placed by a calibrated dentist who was not involved in restoration placement and who was blinded to treatment group. The codes and criteria used for restoration assessment are similar to the ones used in other studies5,18,19 (Table 1). Codes 0, 1 and 2 were considered success and 3, 4, 5, 6, and C, failure. Restorations with codes 7 and 8 were excluded from the analysis.
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2.10.
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At the outset of treatment all patients received standardised dental care to render them dentally fit including extraction of hopeless teeth, non-surgical periodontal treatment and preventative advice. All of the operative caries management was completed by a single operator. This clinician received training in the use of the ART technique in the WHO Collaborating Centre for Oral Health Care Planning and Future Scenarios, University Medical Centre St Radbound, Nijmegen, the Netherlands. Patients were managed according to their allocated treatment group:
Power calculation
Data collection
Operative care
Recruitment of patients, treatment and restoration assessment were undertaken from January 2010 to December 2013. Patients were treated in SFDH hospital with the use of a mobile dental unit and in CUDH on the Restorative Dentistry Clinic.
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2.9.
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Table 1 – Codes and criteria for restoration assessment. Code 0 1 2 3
1) The ART approach consisted of opening of the cavity with an enamel hatchet when necessary (occlusal cavities with no access), removal of soft carious tissue with excavators, conditioning of the cavity with polyacrylic acid for 20 s, washing and drying with cotton pellets and restoration with a high-viscosity glass-ionomer cement (GC Fuji IXTM). Moisture control was achieved with the use of cotton wool rolls and a saliva ejector. A chair-side assistant handmixed the glass-ionomer according to manufacturers’ instructions and it was placed in the cavity using the
Data analysis
All data were entered in SAS1 (Version 9.3) after being hand checked by the principal investigator. Cumulative survival
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Evaluation of restorations
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Criteria Present, in good condition Present, slight marginal defect (0.5 mm), no repair is needed Present, slight wear (0.5 mm), no repair is needed Present, gross marginal defect, repair is needed Present, gross wear, repair is needed Not present, restoration partly or completely missing Not present, restoration replaced by another restoration Tooth is missing Restoration not assessed, patient is not present Caries present
Please cite this article in press as: da Mata C, et al. Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial. Journal of Dentistry (2015), http://dx.doi.org/10.1016/j.jdent.2015.01.003
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proportions at 2 years were defined as the number of restorations still in situ or with acceptable marginal defects or wear after 2 years, divided by the total number of restorations placed in that group. A logistic regression model with survival of the restorations at 24 months (yes/no) as the outcome variable was fitted. The explanatory variables included were: age, gender, number of teeth present, treatment (ART or CT), number of restorations placed, restoration location (coronal vs root, anterior vs posterior), xerostomia (never or sometimes vs often or always), plaque scores (no plaque or little plaque vs moderate to gross deposits of plaque), presence of a removable partial denture (yes/no), and number of occluding pairs at baseline. Eighty-three restorations which were not assessed at 24 months were excluded from the analysis. Therefore the statistical analyses were performed on 217 restorations placed in 71 patients. In the logistic regression model the variables plaque, denture wear, number of occluding pairs and xerostomia were not found to be statistically significant so they were eliminated from the model. A second logistic regression model was fitted without these variables. This ensured that patients who had missing data for some of these variables were included in the analysis, thus increasing the sample size and increasing the power of the analysis. Individual restorations could not be assumed to be independent (more than one restoration per patient) and the usual method of calculating the standard errors of the
logistic regression parameters could not be used. Thus, these parameters were estimated based on 5000 Bootstrap samples of the 71 patients. The tests of significance of the logistic regression parameters were based on these Bootstrap estimates of the standard errors.
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Results
The trial profile is illustrated in Fig. 1. Ninety-nine patients participated in the study and received operative treatment, 46 males and 53 females, with a mean age of 73.2 (SD: 6.8). In total, 300 restorations were placed, 142 restorations for 51 patients in the ART group and 158 restorations for 48 patients in the CT group. This produced a mean of 2.8 ART (SD: 1.83) and 3.2 conventional (SD: 2.62) restorations placed per patient. The mean DMFT score at baseline was 25.74 in the ART group and 28.54 in the CT group. There was no statistically significant difference between the mean decayed teeth component (D) of the two treatment groups prior to intervention (p = 0.332). Table 2 illustrates the baseline demographic and clinical characteristics of each treatment group. During the study the majority of restorations placed were on one surface only (91.3%). For each treatment group, a large number of restorations were placed on root surfaces: 45.2% (62/142) in the ART group and 41.1% (65/158) in the CT group.
Fig. 1 – CONSORT flow diagram. Please cite this article in press as: da Mata C, et al. Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial. Journal of Dentistry (2015), http://dx.doi.org/10.1016/j.jdent.2015.01.003
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Table 2 – Baseline demographic and clinical characteristics according to intervention group.
Gender Male Females Age (years) Mean (SD) General health (no problems with) Mobility Self-care Usual activities Pain Anxiety On regular use of medication Removable prostheses wear Mean number of teeth present (range) DMFT (SD) *p < 0.05 Decayed teeth (SD) p > 0.05
Q7
267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291
ART
CT
26 (51%) 25 (49%)
20 (41.7%) 28 (58.3%)
73.33 (6.28)
73.02 (7.29)
76% 92% 88% 62% 80% 84.3% 56% 16 (3–31) 25.74 (6.3)
72.3% 97.9% 80.9% 55.3% 78.7% 87.5% 55.3% 15 (3–26) 28.54 (5.0)
2.84 (1.7)
3.29 (2.7)
cumulative survival proportion of 90.9% after 2 years. In the CT group, 2 (18.2%) restorations failed after 6 months, 2 (18.2%) after 1 year and 7 (63.6%) after 2 years. Table 3 illustrates the status of all restorations at 6, 12 and 24 months and the cumulative survival proportions at each period. In both treatment groups, failures occurred on root, buccal/lingual, incisal/occlusal and interproximal surfaces. Fig. 2 illustrates the failure characteristics of restorations from both treatment groups according to tooth surfaces after 2 years. Table 4 illustrates the results of the second logistic regression model, fitted without the variables which presented missing data. None of the variables analysed had any effect on restoration survival (all p > 0.05). In particular, the type of treatment (ART or CT) had no effect on restoration survival (p = 0.2050).
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Discussion
This study represents the first randomised clinical trial comparing the use of ART and a conventional restorative approach to treat independently living older patients. Conducting research studies with elderly individuals can be very challenging with high numbers of patients lost to follow up due to changes in health status or death. Therefore, a sample size calculation was performed to allow for a potential 30% drop out rate. After 2 years, 71 of the 99 patients treated were assessed, resulting in a 28.3% loss to follow up; thus the desired sample size was achieved. Previous studies have reported up to 48% drop out rates after one year when treating senior adults.10,11 However, when the ART and CT groups were compared, the loss to follow up after 2 years was 33% and 23% respectively. The majority of patients who were lost to follow up were recruited from SFDH which comprised a more systemically unwell cohort due to their past medical histories. Unfortunately large numbers of these patients were not available for the 2-year review due to death and admission to residential care facilities. The relatively high drop-out rate did not appear to have a negative impact on the results gathered as no systematic differences were observed between those patients who completed the study and those who did not. Furthermore, the differences between the two groups such as age and DMFT were shown not to have any effect on treatment by the logistic regression analysis. Dry mouth (xerostomia) is a common finding in elderly patients and in this trial, the majority reported some degree of
Other surfaces treated included mesial/distal (29.2% of ART, 22.8% of CT restorations), buccal/lingual (8.7% of ART, 13.3% of CT restorations) and occlusal/incisal (10.9% of ART, 13.9% of CT restorations). After 2 years, 71 patients completed the RCT (71.2%): 34 from the ART group and 37 from the CT group. When compared to patients who completed the trial, the patients who were lost to follow up presented similar DMFT, number of decayed teeth and number of restorations received in the study (p > 0.05). Patients who did not complete the study presented a mean age of 77.1 years compared to 71.5 years for those who completed the trial (p < 0.05). In total, 96 restorations (67.6%) were assessed in the ART group and 121 restorations (76.6%) were assessed in CT group. In the ART group, 74 (77%) restorations were assessed as being in good condition, 6 (6.2%) had a slight marginal defect, 2 (2%) had slight wear and 13 (13.5%) were partly or completely missing. One restoration (1%) in this group presented with secondary caries. This resulted in a cumulative survival proportion of 85.4% after 2 years. Among the failures in the ART group, 4 (28.6%) occurred after 6 months, 4 (28.6%) after 1 year and 6 (42.8%) after 2 years. In the CT group, 97 (80.1%) restorations were assessed as good condition, 13 (10.7%) had an acceptable marginal defect and 11 (9%) were partly or completely missing, resulting in a
Table 3 – Restorations status at the different assessed periods. Restorations status
Total assessed Present, in good condition Acceptable marginal defect or wear Restoration partly or completely missinga Caries presenta Total failures Cumulative survival proportions a
6 months
1 year
2 years
ART
CT
ART
CT
ART
CT
118 (83%) 108 (91.5%) 6 (5%) 4 (3.3%) 0 4/118 96.6%
124 (78.4%) 115 (92.7%) 7 (5.6%) 2 (1.6%) 0 2/124 98.3%
127 (89.4%) 111 (87.4%) 8 (6.2%) 7 (5.5%) 1 (0.7%) 8/127 93.7%
141 (89.2%) 126 (89.3%) 11 (7.8%) 4 (2.8%) 0 4/141 97.1%
96 (67.6%) 74 (77%) 8 (8.3%) 13 (13.5%) 1 (1%) 14/96 85.4%
121 (77.2%) 97 (80.1%) 13 (10.7%) 11 (9%) 0 11/121 90.9%
Failure.
Please cite this article in press as: da Mata C, et al. Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial. Journal of Dentistry (2015), http://dx.doi.org/10.1016/j.jdent.2015.01.003
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Fig. 2 – Failures of ART and CT restorations after 2 years, according to tooth surfaces.
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dry mouth. Even though a link between survival of restorations and dry mouth could not be demonstrated here, it is known that low salivary flow rates can be associated with increased caries incidence.20 Secondary caries has been shown to be one of the main causes of restoration failure.21,22 However, given the relatively low failure rate, it did not impact upon survival of the restorations in either group at 24 months. At baseline, the oral hygiene of this patient group was poor with 74.5% of patients presenting with moderate to large amounts of plaque present. This study did not demonstrate a clear association between plaque scores at baseline and restoration failure. Nevertheless, it is widely accepted that plaque is an important caries risk factor, and as such is related to restoration survival. Older patients might be unfamiliar with oral hygiene procedures or may require education to perform them correctly. Additionally, a decrease in manual dexterity can be a common finding among senior individuals.
Table 4 – Odds ratio (OR) and 95% confidence intervals (95%CI) for survival of restorations according to different variables. Variable Age Gender Male Female Number of teeth present Treatment ART CT Number of restorations Restoration location Anterior Posterior Restoration location Coronal Root
Estimate Standard Odds 95% CI p-value error ratio 0.036 0.090
0.053 0.539
0.96 1.09
0.87 1.07 0.38 3.15
0.4932 0.8664
0.017
0.048
1.02
0.93 1.12
0.7188
0.754
0.595
0.47
0.15 1.51
0.2050
0.059
0.108
0.94
0.76 1.17
0.5841
0.694
0.623
0.50
0.15 1.69
0.2650
0.464
0.909
0.63
0.11 3.73
0.6092
Therefore, preventive programmes with oral hygiene instructions could be beneficial to this population. Large numbers of the restorations in both groups were placed in the root surface and this is where a large number of failures occurred. A recent study on the use of ART to restore root carious lesions reported relatively low survival rates (62%) after 2 years.12 The root surface is a difficult site to restore, with moisture control particularly challenging. Furthermore, the size of the cavity may have had an effect on the survival of restorations on the root surface, but cavity size was not measured in this study. It is known that root caries lesions often spread by covering a larger surface area, sometimes encircling the entire root, instead of deep penetration.23,24 This can make caries removal and the entire restorative procedure more difficult, resulting in less than ideal restorations. Thus, prevention and early diagnosis are particularly important in older patients, influencing treatment success. A higher number of failures occurred from year 1 to year 2, in both groups, compared to 6- and 12-month assessments. This reinforces the importance of an effective preventive programme together with placement of restorations in order to increase the chances of early diagnosis and repair rather than replacement of restorations. Some slight marginal defects will eventually result in complete loss of restorations. Maybe marginal defects could have been repaired before the restoration was completely lost if these patients were on a maintenance programme. Also, it could have been the case that patients were more motivated in the early stages of the study, after having received oral hygiene instructions, being more pro-active in terms of oral health care. Restoration survival rates were high in both groups and there was no statistically significant difference observed between the two interventions ( p = 0.2050). Although restorations were placed under ideal conditions, this should not be considered as a source of bias, as this was the case for both groups. However, longer follow -up periods could increase the difference in favour of either technique and it would be interesting to see if restoration failure rates would stabilise after a certain period of time or continue to drop.
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Conclusions
This study illustrated that in terms of restoration survival after 2 years there were no statistically significant differences between ART and conventional caries removal for partially dentate older adults. An ART based approach to caries management appears to be a suitable approach to treat older patients with high levels of survival of restorations after 2 years. This technique could represent an effective, easy to administer and less costly alternative to treat carious lesions in the elderly and, together with preventive measures might be an aid to stop caries progression, which could result in tooth loss.
Uncited reference Ref. 17.
Please cite this article in press as: da Mata C, et al. Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial. Journal of Dentistry (2015), http://dx.doi.org/10.1016/j.jdent.2015.01.003
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Q5
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Acknowledgements The study protocol was approved by the Cork Dental School and Hospital Ethics Committee (ECM 5 (4) 02/09/08). This study Q6 was funded by the Irish Health Research Board (Grant number: HRAPOR/2010/154).
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1. Marcenes W, Kassebaum N, Bernabe´ E, Flaxman A, Naghavi M, Lopez A, et al. Global burden of oral conditions in 1990– 2010: a systematic analysis. Journal of Dental Research 2013;92:592–7. 2. Cunningham SJ. Economic evaluation of healthcare – is it important to us? British Dental Journal 2000;188:250–4. 3. Woods N, Whelton H, Crowley T, Stephenson I, Ormsby M. An aging population – have we got an Oral Health Policy? Irish Journal of Public Policy 2009;1:18–28. 4. Listl S, Moran V, Maurer J, Faggion CM. Dental service utilization by Europeans aged 50 plus. Community Dentistry and Oral Epidemiology 2012;40:164–74. 5. Frencken JE, Taifour D, van’t Hof MA. Survival of ART and amalgam restorations in permanent teeth of children after 6.3 years. Journal of Dental Research 2006;85:622–6. 6. Zanata RL, Fagundes TC, Freitas MC, Lauris JR, Navarro MF. Ten-year survival of ART restorations in permanent posterior teeth. Clinical Oral Investigations 2011;15:265–71. 7. Mickenautsch S, Frencken JE, van’t HM. Atraumatic restorative treatment and dental anxiety in outpatients attending public oral health clinics in South Africa. Journal of Public Health Dentistry 2007;67:179–84. 8. Putthasri W, Pitiphat W, Phantumvanit P, Songpaisan Y. Cost-effectiveness analysis in atraumatic restorative treatment (ART) technique compare to conventional amalgam teachnique. Khon Kaen University Dental Journal 2011;2:39–43. 9. da Mata C, Allen PF, Cronin M, O’Mahony D, McKenna G, Woods N. Cost-effectiveness of ART restorations in elderly adults: a randomized clinical trial. Community Dentistry and Oral Epidemiology 2014;42:79–87. 10. Honkala S, Honkala E. Atraumatic dental treatment among Finnish elderly persons. Journal of Oral Rehabilitation 2002;29:435–40.
11. Lo EC, Luo Y, Tan HP, Dyson JE, Corbet EF. ART and conventional root restorations in elders after 12 months. Journal of Dental Research 2006;85:929–32. 12. Gil-Montoya J, Mateos-Palacios R, Bravo M, Gonza´lez-Moles M, Pulgar R. Atraumatic restorative treatment and Carisolv use for root caries in the elderly: 2-year follow-up randomized clinical trial. Clinical Oral Investigations 2014;18:1089–95. 13. Frencken JE. Evolution of the ART approach: highlights and achievements. Journal of Applied Oral Science 2009;17:78–83. 14. Pilot T. Introduction – ART from a global perspective. Community Dentistry and Oral Epidemiology 1999;27:421–2. 15. Chalmers JM. Minimal intervention dentistry: part 1. Strategies for addressing the new caries challenge in older patients. Journal of the Canadian Dental Association 2006;72:427–33. 16. Frencken JE, Leal SC, Navarro MF. Twenty-five-year atraumatic restorative treatment (ART) approach: a comprehensive overview. Clinical Oral Investigations 2012;16:1337–46. 17. Marchini L, Vieira P, Bossan T, Montenegro F, Cunha V. Selfreported oral hygiene habits among institutionalised elderly and their relationship to the condition of oral tissues in Taubate´, Brazil. Gerodontology 2006;23:33–7. 18. Cefaly DF, Barata Tde J, Tapety CM, Bresciani E, Navarro MF. Clinical evaluation of multisurface ART restorations. Journal of Applied Oral Science 2005;13:15–9. 19. Holmgren CJ, Lo E, Hu D, Wan H. ART restorations and sealants placed in Chinese school children – results after three years. Community Dentistry and Oral Epidemiology 2000;28:314–20. 20. Astrom AN, Ekback G, Nasir E, Ordell S, Unell L. Use of dental services throughout middle and early old ages: a prospective cohort study. Community Dentistry and Oral Epidemiology 2013;41:30–9. 21. Kopperud SE, Tveit AB, Gaarden T, Sandvik L, Espelid I. Longevity of posterior dental restorations and reasons for failure. European Journal of Oral Sciences 2012;120:539–48. 22. Demarco FF, Correˆa MB, Cenci MS, Moraes RR, Opdam NJ. Longevity of posterior composite restorations: not only a matter of materials. Dental Materials 2012;28:87–101. 23. Smith PW, Preston KP, Higham SM. Development of an in situ root caries model. A. In vitro investigations. Journal of Dentistry 2005;33:253–67. 24. Fejerskov O, Luan W, Nyvad B, Budtz-Jørgensen E, HolmPedersen P. Active and inactive root surface caries lesions in a selected group of 60- to 80-year-old Danes. Caries Research 1991;25:385–91.
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Please cite this article in press as: da Mata C, et al. Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial. Journal of Dentistry (2015), http://dx.doi.org/10.1016/j.jdent.2015.01.003
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.intl.elsevierhealth.com/journals/jden 1 2 3
Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial
4 5
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Q1
Cristiane da Mata a,*, P. Finbarr Allen a, Gerald McKenna b, Michael Cronin c, Denis O’Mahony d, Noel Woods e a
Cork University Dental School and Hospital, University College Cork, Ireland
b
Q2 Centre for Dentistry, Queens University Belfast, Northern Ireland, United Kingdom c
School of Mathematical Sciences, University College Cork, Ireland School of Medicine, University College Cork, Ireland e Centre for Policy Studies, University College Cork, Ireland d
article info
abstract
Article history:
Objectives: Older dentate adults are a high caries risk group who could potentially benefit
Received 9 November 2014
from the use of the atraumatic restorative treatment (ART). This study aimed to compare the
Received in revised form
survival of ART and a conventional restorative technique (CT) using rotary instruments and
1 January 2015
a resin-modified glass-ionomer for restoring carious lesions as part of a preventive and
Accepted 7 January 2015
restorative programme for older adults after 2 years.
Available online xxx
Methods: In this randomised controlled clinical trial, 99 independently living adults
Keywords:
conventional restorations. The survival of restorations was assessed by an independent
(65–90 years) with carious lesions were randomly allocated to receive either ART or Atraumatic restorative treatment
and blinded examiner 6 months, 1 year and 2 years after restoration placement.
Elderly
Results: Ninety-six (67.6%) and 121 (76.6%) restorations were assessed in the ART and CT
Caries
groups, respectively, after 2 years. The cumulative restoration survival percentages after
Partially dentate
2 years were 85.4% in the ART and 90.9% in the CT group. No statistically significant between group differences were detected (p = 0.2050, logistic regression analysis). Conclusions: In terms of restoration survival, ART was as effective as a conventional restorative approach to treat older adults after 2 years. This technique could be a useful tool to provide dental care for older adults particularly in the non-clinical setting. (Trial Registration number: ISRCTN 76299321). Clinical Significance: The results of this study show that ART presented survival rates similar to conventional restorations in older adults. ART appears to be a cost-effective way to provide dental care to elderly patients, particularly in out of surgery facilities, such as nursing homes. # 2015 Published by Elsevier Ltd.
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* Corresponding author. Tel.: +353 021 420 1100; fax: +353 021 490 1193. E-mail address: [email protected] (C. da Mata). http://dx.doi.org/10.1016/j.jdent.2015.01.003 0300-5712/# 2015 Published by Elsevier Ltd.
Please cite this article in press as: da Mata C, et al. Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial. Journal of Dentistry (2015), http://dx.doi.org/10.1016/j.jdent.2015.01.003
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Q3 1.
Introduction
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2.
Materials and methods
2.1.
Study design
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Q4 Dental caries is a major public health problem in many
countries worldwide and despite all the advances in its diagnosis, prevention and treatment, untreated dental caries still has a high prevalence. According to a 2010 report, untreated dental caries in permanent teeth was the most prevalent condition evaluated by a study on the global burden of diseases, with a prevalence of 35% for all ages combined.1 Older patients are helping inflate these figures as the population around the globe is ageing rapidly and the global burden of oral conditions in older patients is shifting from complete tooth loss towards periodontitis and untreated caries.1 Furthermore, provision of oral healthcare to older adults is often inadequate and in developed countries, despite the availability of oral health services, dental uptake among older individuals can be very low.2–4 Conventional dental treatment might not be acceptable or accessible to older patients, particularly frail elderly or nursing home residents, and providing suitable and cost-effective dental treatment to this population can be challenging. Governments, policy makers and society in general need to address this problem, in order to improve elderly individuals’ oral health, and consequently their quality of life. Therefore, an alternative technique to restore carious teeth that could prove to be acceptable to elderly patients, cost-effective and easy to administer should be considered. The atraumatic restorative treatment (ART) approach could be such an option as studies suggest good restoration survival rates and patient acceptabiliy .5–8 A recent study has also demonstrated the cost-effectiveness of ART in the treatment of elderly patients compared to conventional approaches .9 However very few other studies have reported on the use of ART in the elderly, with small samples and short follow -up periods described.10–12 None of these previous reports include community-dwelling independent elderly adults, nor do they report medium to long term survival rates of ART compared to conventional techniques. ART was initially used as an alternative to treat caries in underserved communities where resources such as electricity, piped water, dental equipment and finance were rarely available .13 However, ART has potential applications in industrialised countries and seems to be a promising approach to treat elderly patients, especially homebound older adults and those living in nursing homes .14 This population has traditionally had limited access to routine dental care and consequently, are at a higher risk of developing caries .15 Twenty-five years after the results of the first pilot study, ART, as part of a Basic Package of Oral Care, has become an important cornerstone for the development of global oral health and for the minimisation of inequalities in oral care, particularly in vulnerable and underserved populations such as the elderly .16 The aim of this study was to compare the 2-year survival of restorations placed according to the principles of ART compared to conventional restorations in partially dentate older patients. The null hypothesis for the study stated that the survival of ART restorations would be no worse than those placed according to a conventional approach.
A randomised controlled clinical trial (Trial registration number: ISRCTN 76299321) was conducted using a parallel group design. The study protocol was submitted and given full ethical approval by the Clinical Ethics Committee of the Cork Teaching Hospitals (ECM 5 (4) 02/09/08). Each patient was provided with written information detailing the proposed treatment involved and each patient completed a written consent form prior to clinical examination.
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2.2.
86
Recruitment
Partially dentate older patients (>65 years) were recruited from two centres: Cork University Dental Hospital (CUDH) and St Finbarr’s Geriatric Day Hospital (SFDH) in Cork, Ireland. Those patients in SFDH represented a more systemically unwell and older cohort as they attended the Geriatric Day Hospital to receive a range of medical treatments. Advertisements inviting patients to participate in the study were entered in the newsletter of a church near to CUDH for 6 months. The same advertisement was placed in the waiting areas of CUDH and SFDH. Contact details of the study coordinator were provided and patients were allocated appointments. All of the patients recruited to the study were independently living elderly with various levels of comorbidity.
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2.3.
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Clinical examination
Upon entering the study each patient received a clinical examination which charted hard tissues, periodontal condition, caries and number of occluding contacts. Each intra-oral examination was carried out by two calibrated dentists (interexaminer consistency kappa score = 0.88) who had received prior training by a gold standard examiner. Patients who met the inclusion criteria for the study were invited to participate and given a confidential trial identifier.
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2.4.
110
Inclusion and exclusion criteria
The inclusion criteria for entering this study were: 65 years of age or older; presence of at least one dentinal carious lesion (coronal or root) with no painful symptomatology; and able to perform mechanical oral hygiene techniques including toothbrushing. Patients who presented with carious teeth with a history of pain, cavities resulting from attrition, erosion or abrasion, with no caries, and teeth with significant periodontal involvement (Grade III mobility), were excluded from the study.
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2.5.
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Randomisation
Patients were randomly allocated to two different treatment groups: the ART group and the conventional treatment (CT) group. Randomisation was performed using a computer generated schedule in SAS1. Patient randomisation was
Please cite this article in press as: da Mata C, et al. Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial. Journal of Dentistry (2015), http://dx.doi.org/10.1016/j.jdent.2015.01.003
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‘‘press-finger’’ technique whenever the type of cavity allowed. In the case of root restorations, a glove coated with petroleum jelly was used similarly to the ‘‘pressfinger’’ technique to better condense the material into the cavity. Excess material was removed with a carver after checking the occlusion and the restoration was coated with petroleum jelly. 2) The treatment protocol for those patients in the CT group consisted of provision of local anaesthesia, use of rotary instruments for access and removal of carious tissue, conditioning of the cavity with a polyacrylic acid for 20 s, washing and drying with cotton pellets and placement of a hand-mixed resin-modified glass-ionomer (GC Fuji II LCTM). Isolation was achieved using the procedure described for ART restorations. The restorative material was light-cured for 20 s and the restoration was polished with soflex discs after checking the occlusion. The final restoration was then coated with G-coat plus according to manufacturers’ instructions.
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conducted by a research assistant and the allocation was concealed from the clinical operator using sequentially numbered, opaque, sealed envelopes.
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2.6.
129 130 131 132 133 134 135 136 137 138 139
A sample size calculation was performed in order to demonstrate non-inferiority of ART survival rate relative to conventional treatment after one year. The survival of conventional restorations was estimated to be 92.1% as shown in a previous study with a similar population.11 With a non-inferiority limit of 10% regarded as a clinically insignificant difference, a 5% significance level and a power of 80%, a sample size of 129 restorations per group was necessary, allowing for a 30% drop out rate. To ensure adequate power, an achieved sample size of 90 restorations per group was required at two-year followup.
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2.7.
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Each patient completed a questionnaire which recorded age, gender, place of residence (e.g., independently living, assisted by home help), general health, medical history (including xerostomia) and oral hygiene practices. Clinical examinations were performed, and details of carious lesions, restorations and teeth present were recorded. Plaque scores were recorded at baseline using the mucosal plaque score (MPS) index. The following criteria were used for the detection and classification of root caries: 1 – colour (light/dark brown/black); 2 – texture (smooth, rough); 3 – appearance (shiny or glossy, matte or non-glossy); 4 – perception on gentle probing (soft, leathery, hard); and 5 – cavitation (loss of anatomical contour). A caries code was given when the lesion was yellowish/light brown, with a rough texture, and appeared non-glossy and soft or leathery to probing.
Patients were reviewed 6 months, 1 year and 2 years after the restorations had been placed by a calibrated dentist who was not involved in restoration placement and who was blinded to treatment group. The codes and criteria used for restoration assessment are similar to the ones used in other studies5,18,19 (Table 1). Codes 0, 1 and 2 were considered success and 3, 4, 5, 6, and C, failure. Restorations with codes 7 and 8 were excluded from the analysis.
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2.8.
2.10.
213
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At the outset of treatment all patients received standardised dental care to render them dentally fit including extraction of hopeless teeth, non-surgical periodontal treatment and preventative advice. All of the operative caries management was completed by a single operator. This clinician received training in the use of the ART technique in the WHO Collaborating Centre for Oral Health Care Planning and Future Scenarios, University Medical Centre St Radbound, Nijmegen, the Netherlands. Patients were managed according to their allocated treatment group:
Power calculation
Data collection
Operative care
Recruitment of patients, treatment and restoration assessment were undertaken from January 2010 to December 2013. Patients were treated in SFDH hospital with the use of a mobile dental unit and in CUDH on the Restorative Dentistry Clinic.
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2.9.
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Table 1 – Codes and criteria for restoration assessment. Code 0 1 2 3
1) The ART approach consisted of opening of the cavity with an enamel hatchet when necessary (occlusal cavities with no access), removal of soft carious tissue with excavators, conditioning of the cavity with polyacrylic acid for 20 s, washing and drying with cotton pellets and restoration with a high-viscosity glass-ionomer cement (GC Fuji IXTM). Moisture control was achieved with the use of cotton wool rolls and a saliva ejector. A chair-side assistant handmixed the glass-ionomer according to manufacturers’ instructions and it was placed in the cavity using the
Data analysis
All data were entered in SAS1 (Version 9.3) after being hand checked by the principal investigator. Cumulative survival
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Evaluation of restorations
4 5 6 7 8 C
Criteria Present, in good condition Present, slight marginal defect (0.5 mm), no repair is needed Present, slight wear (0.5 mm), no repair is needed Present, gross marginal defect, repair is needed Present, gross wear, repair is needed Not present, restoration partly or completely missing Not present, restoration replaced by another restoration Tooth is missing Restoration not assessed, patient is not present Caries present
Please cite this article in press as: da Mata C, et al. Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial. Journal of Dentistry (2015), http://dx.doi.org/10.1016/j.jdent.2015.01.003
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proportions at 2 years were defined as the number of restorations still in situ or with acceptable marginal defects or wear after 2 years, divided by the total number of restorations placed in that group. A logistic regression model with survival of the restorations at 24 months (yes/no) as the outcome variable was fitted. The explanatory variables included were: age, gender, number of teeth present, treatment (ART or CT), number of restorations placed, restoration location (coronal vs root, anterior vs posterior), xerostomia (never or sometimes vs often or always), plaque scores (no plaque or little plaque vs moderate to gross deposits of plaque), presence of a removable partial denture (yes/no), and number of occluding pairs at baseline. Eighty-three restorations which were not assessed at 24 months were excluded from the analysis. Therefore the statistical analyses were performed on 217 restorations placed in 71 patients. In the logistic regression model the variables plaque, denture wear, number of occluding pairs and xerostomia were not found to be statistically significant so they were eliminated from the model. A second logistic regression model was fitted without these variables. This ensured that patients who had missing data for some of these variables were included in the analysis, thus increasing the sample size and increasing the power of the analysis. Individual restorations could not be assumed to be independent (more than one restoration per patient) and the usual method of calculating the standard errors of the
logistic regression parameters could not be used. Thus, these parameters were estimated based on 5000 Bootstrap samples of the 71 patients. The tests of significance of the logistic regression parameters were based on these Bootstrap estimates of the standard errors.
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Results
The trial profile is illustrated in Fig. 1. Ninety-nine patients participated in the study and received operative treatment, 46 males and 53 females, with a mean age of 73.2 (SD: 6.8). In total, 300 restorations were placed, 142 restorations for 51 patients in the ART group and 158 restorations for 48 patients in the CT group. This produced a mean of 2.8 ART (SD: 1.83) and 3.2 conventional (SD: 2.62) restorations placed per patient. The mean DMFT score at baseline was 25.74 in the ART group and 28.54 in the CT group. There was no statistically significant difference between the mean decayed teeth component (D) of the two treatment groups prior to intervention (p = 0.332). Table 2 illustrates the baseline demographic and clinical characteristics of each treatment group. During the study the majority of restorations placed were on one surface only (91.3%). For each treatment group, a large number of restorations were placed on root surfaces: 45.2% (62/142) in the ART group and 41.1% (65/158) in the CT group.
Fig. 1 – CONSORT flow diagram. Please cite this article in press as: da Mata C, et al. Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial. Journal of Dentistry (2015), http://dx.doi.org/10.1016/j.jdent.2015.01.003
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Table 2 – Baseline demographic and clinical characteristics according to intervention group.
Gender Male Females Age (years) Mean (SD) General health (no problems with) Mobility Self-care Usual activities Pain Anxiety On regular use of medication Removable prostheses wear Mean number of teeth present (range) DMFT (SD) *p < 0.05 Decayed teeth (SD) p > 0.05
Q7
267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291
ART
CT
26 (51%) 25 (49%)
20 (41.7%) 28 (58.3%)
73.33 (6.28)
73.02 (7.29)
76% 92% 88% 62% 80% 84.3% 56% 16 (3–31) 25.74 (6.3)
72.3% 97.9% 80.9% 55.3% 78.7% 87.5% 55.3% 15 (3–26) 28.54 (5.0)
2.84 (1.7)
3.29 (2.7)
cumulative survival proportion of 90.9% after 2 years. In the CT group, 2 (18.2%) restorations failed after 6 months, 2 (18.2%) after 1 year and 7 (63.6%) after 2 years. Table 3 illustrates the status of all restorations at 6, 12 and 24 months and the cumulative survival proportions at each period. In both treatment groups, failures occurred on root, buccal/lingual, incisal/occlusal and interproximal surfaces. Fig. 2 illustrates the failure characteristics of restorations from both treatment groups according to tooth surfaces after 2 years. Table 4 illustrates the results of the second logistic regression model, fitted without the variables which presented missing data. None of the variables analysed had any effect on restoration survival (all p > 0.05). In particular, the type of treatment (ART or CT) had no effect on restoration survival (p = 0.2050).
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4.
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Discussion
This study represents the first randomised clinical trial comparing the use of ART and a conventional restorative approach to treat independently living older patients. Conducting research studies with elderly individuals can be very challenging with high numbers of patients lost to follow up due to changes in health status or death. Therefore, a sample size calculation was performed to allow for a potential 30% drop out rate. After 2 years, 71 of the 99 patients treated were assessed, resulting in a 28.3% loss to follow up; thus the desired sample size was achieved. Previous studies have reported up to 48% drop out rates after one year when treating senior adults.10,11 However, when the ART and CT groups were compared, the loss to follow up after 2 years was 33% and 23% respectively. The majority of patients who were lost to follow up were recruited from SFDH which comprised a more systemically unwell cohort due to their past medical histories. Unfortunately large numbers of these patients were not available for the 2-year review due to death and admission to residential care facilities. The relatively high drop-out rate did not appear to have a negative impact on the results gathered as no systematic differences were observed between those patients who completed the study and those who did not. Furthermore, the differences between the two groups such as age and DMFT were shown not to have any effect on treatment by the logistic regression analysis. Dry mouth (xerostomia) is a common finding in elderly patients and in this trial, the majority reported some degree of
Other surfaces treated included mesial/distal (29.2% of ART, 22.8% of CT restorations), buccal/lingual (8.7% of ART, 13.3% of CT restorations) and occlusal/incisal (10.9% of ART, 13.9% of CT restorations). After 2 years, 71 patients completed the RCT (71.2%): 34 from the ART group and 37 from the CT group. When compared to patients who completed the trial, the patients who were lost to follow up presented similar DMFT, number of decayed teeth and number of restorations received in the study (p > 0.05). Patients who did not complete the study presented a mean age of 77.1 years compared to 71.5 years for those who completed the trial (p < 0.05). In total, 96 restorations (67.6%) were assessed in the ART group and 121 restorations (76.6%) were assessed in CT group. In the ART group, 74 (77%) restorations were assessed as being in good condition, 6 (6.2%) had a slight marginal defect, 2 (2%) had slight wear and 13 (13.5%) were partly or completely missing. One restoration (1%) in this group presented with secondary caries. This resulted in a cumulative survival proportion of 85.4% after 2 years. Among the failures in the ART group, 4 (28.6%) occurred after 6 months, 4 (28.6%) after 1 year and 6 (42.8%) after 2 years. In the CT group, 97 (80.1%) restorations were assessed as good condition, 13 (10.7%) had an acceptable marginal defect and 11 (9%) were partly or completely missing, resulting in a
Table 3 – Restorations status at the different assessed periods. Restorations status
Total assessed Present, in good condition Acceptable marginal defect or wear Restoration partly or completely missinga Caries presenta Total failures Cumulative survival proportions a
6 months
1 year
2 years
ART
CT
ART
CT
ART
CT
118 (83%) 108 (91.5%) 6 (5%) 4 (3.3%) 0 4/118 96.6%
124 (78.4%) 115 (92.7%) 7 (5.6%) 2 (1.6%) 0 2/124 98.3%
127 (89.4%) 111 (87.4%) 8 (6.2%) 7 (5.5%) 1 (0.7%) 8/127 93.7%
141 (89.2%) 126 (89.3%) 11 (7.8%) 4 (2.8%) 0 4/141 97.1%
96 (67.6%) 74 (77%) 8 (8.3%) 13 (13.5%) 1 (1%) 14/96 85.4%
121 (77.2%) 97 (80.1%) 13 (10.7%) 11 (9%) 0 11/121 90.9%
Failure.
Please cite this article in press as: da Mata C, et al. Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial. Journal of Dentistry (2015), http://dx.doi.org/10.1016/j.jdent.2015.01.003
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Fig. 2 – Failures of ART and CT restorations after 2 years, according to tooth surfaces.
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dry mouth. Even though a link between survival of restorations and dry mouth could not be demonstrated here, it is known that low salivary flow rates can be associated with increased caries incidence.20 Secondary caries has been shown to be one of the main causes of restoration failure.21,22 However, given the relatively low failure rate, it did not impact upon survival of the restorations in either group at 24 months. At baseline, the oral hygiene of this patient group was poor with 74.5% of patients presenting with moderate to large amounts of plaque present. This study did not demonstrate a clear association between plaque scores at baseline and restoration failure. Nevertheless, it is widely accepted that plaque is an important caries risk factor, and as such is related to restoration survival. Older patients might be unfamiliar with oral hygiene procedures or may require education to perform them correctly. Additionally, a decrease in manual dexterity can be a common finding among senior individuals.
Table 4 – Odds ratio (OR) and 95% confidence intervals (95%CI) for survival of restorations according to different variables. Variable Age Gender Male Female Number of teeth present Treatment ART CT Number of restorations Restoration location Anterior Posterior Restoration location Coronal Root
Estimate Standard Odds 95% CI p-value error ratio 0.036 0.090
0.053 0.539
0.96 1.09
0.87 1.07 0.38 3.15
0.4932 0.8664
0.017
0.048
1.02
0.93 1.12
0.7188
0.754
0.595
0.47
0.15 1.51
0.2050
0.059
0.108
0.94
0.76 1.17
0.5841
0.694
0.623
0.50
0.15 1.69
0.2650
0.464
0.909
0.63
0.11 3.73
0.6092
Therefore, preventive programmes with oral hygiene instructions could be beneficial to this population. Large numbers of the restorations in both groups were placed in the root surface and this is where a large number of failures occurred. A recent study on the use of ART to restore root carious lesions reported relatively low survival rates (62%) after 2 years.12 The root surface is a difficult site to restore, with moisture control particularly challenging. Furthermore, the size of the cavity may have had an effect on the survival of restorations on the root surface, but cavity size was not measured in this study. It is known that root caries lesions often spread by covering a larger surface area, sometimes encircling the entire root, instead of deep penetration.23,24 This can make caries removal and the entire restorative procedure more difficult, resulting in less than ideal restorations. Thus, prevention and early diagnosis are particularly important in older patients, influencing treatment success. A higher number of failures occurred from year 1 to year 2, in both groups, compared to 6- and 12-month assessments. This reinforces the importance of an effective preventive programme together with placement of restorations in order to increase the chances of early diagnosis and repair rather than replacement of restorations. Some slight marginal defects will eventually result in complete loss of restorations. Maybe marginal defects could have been repaired before the restoration was completely lost if these patients were on a maintenance programme. Also, it could have been the case that patients were more motivated in the early stages of the study, after having received oral hygiene instructions, being more pro-active in terms of oral health care. Restoration survival rates were high in both groups and there was no statistically significant difference observed between the two interventions ( p = 0.2050). Although restorations were placed under ideal conditions, this should not be considered as a source of bias, as this was the case for both groups. However, longer follow -up periods could increase the difference in favour of either technique and it would be interesting to see if restoration failure rates would stabilise after a certain period of time or continue to drop.
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Conclusions
This study illustrated that in terms of restoration survival after 2 years there were no statistically significant differences between ART and conventional caries removal for partially dentate older adults. An ART based approach to caries management appears to be a suitable approach to treat older patients with high levels of survival of restorations after 2 years. This technique could represent an effective, easy to administer and less costly alternative to treat carious lesions in the elderly and, together with preventive measures might be an aid to stop caries progression, which could result in tooth loss.
Uncited reference Ref. 17.
Please cite this article in press as: da Mata C, et al. Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial. Journal of Dentistry (2015), http://dx.doi.org/10.1016/j.jdent.2015.01.003
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Acknowledgements The study protocol was approved by the Cork Dental School and Hospital Ethics Committee (ECM 5 (4) 02/09/08). This study Q6 was funded by the Irish Health Research Board (Grant number: HRAPOR/2010/154).
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references
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Please cite this article in press as: da Mata C, et al. Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial. Journal of Dentistry (2015), http://dx.doi.org/10.1016/j.jdent.2015.01.003
