journal of dentistry 42 (2014) 149–157
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Clinical comparison of a flowable composite and fissure sealant: A 24-month split-mouth, randomized, and controlled study Ugur Erdemir a,*, Hande Sar Sancakli a, Batu Can Yaman b, Sevda Ozel c, Taner Yucel a, Esra Yıldız a a
Istanbul University, Faculty of Dentistry, Department of Operative Dentistry, 34093 Capa-Istanbul, Turkey Osmangazi University, Faculty of Dentistry, Department of Operative Dentistry, 26480 Eskisehir, Turkey c Istanbul University, Faculty of Medicine, Department of Biostatistics and Medical Informatics, 34093 Capa-Istanbul, Turkey b
article info
abstract
Article history:
Objectives: The aim of this clinical study was to evaluate the retention rate and caries-
Received 23 May 2013
prevention effect of a flowable composite compared to a conventional resin-based sealant in
Received in revised form
a young population over a 24-month period.
18 November 2013
Methods: Thirty-four patients, ranging in age from 16 to 22 years, diagnosed with at least 2
Accepted 21 November 2013
non-cavitated pit-and-fissure caries in the first and second molars were selected for this randomized split-mouth design trial. A total of 220 sealants, were placed in 117 upper molars and 103 lower molars. The teeth were sealed with a flowable resin composite (Tetric
Keywords:
Evo Flow) or a sealant material (Helioseal F). Each restoration was independently evaluated
Fissure caries
in terms of retention and the presence of caries at baseline and at 1, 6, 12, and 24 months.
Fissure sealant
Data were analyzed using non-parametric Mann–Whitney U and Friedman 1-way ANOVA
Flowable composite
tests at p < 0.05.
Clinical study
Results: Tetric Evo Flow showed complete retention with 100%, 95.5%, 93.8%, and 88.5% at 1,
Retention
6, 12, and 24-month evaluations, respectively, while Helioseal F retention rates were 98.1%, 95.5%, 94.8%, and 85.4%, respectively, for the same evaluation periods. At the 24-month recall, 4 (4.2%) total losses were observed in subjects treated with Tetric Evo Flow and 2 total losses (2.1%) for Helioseal F, respectively. No significant differences were observed between the materials in retention rates or caries incidence for each evaluation period ( p > 0.05). Conclusion: Placement of flowable composite as fissure sealants in the younger population seems to be as effective as conventional fluoride containing fissure sealants for the prevention of fissure caries. Clinical relevance: The use of a flowable composite as a fissure sealant material, in conjunction with a total-etch, single bottle adhesive, yielded better retention than did the conventional fluoride containing resin-based fissure sealant over a 24-month period in young patients. # 2013 Elsevier Ltd. All rights reserved.
* Corresponding author. Tel.: +90 212 414 2020x30369; fax: +90 212 525 0075. E-mail addresses: [email protected], [email protected] (U. Erdemir), [email protected] (H.S. Sancakli), [email protected] (B.C. Yaman), [email protected] (S. Ozel), [email protected] (T. Yucel), [email protected] (E. Yıldız). 0300-5712/$ – see front matter # 2013 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jdent.2013.11.015
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1.
journal of dentistry 42 (2014) 149–157
Introduction
Although the field of dentistry has shown outstanding scientific advances in restorative materials and innovative prevention techniques over recent decades, dental caries remains a highly prevalent pathology worldwide.1,2 Although fluorides are highly effective in preventing caries on smooth surfaces, they are not equally effective in protecting occlusal surfaces.3 Reasons for this include the ‘‘morphology of occlusal pits and fissures that make mechanical cleaning difficult and facilitate the retention of bacteria, nutrients, and debris’’.4 Therefore, a specific barrier between the tooth surface and the oral environment is needed to avoid the development of caries. One of the most appropriate and cost effective treatments for the prevention of occlusal caries in children and adolescents at high risk is the application of pitand-fissure sealants.4–10 Pit-and-fissure sealants were introduced in the 1960s as an efficient caries prevention method and have shown high retention rates.11,12 Most of the sealant materials used today are resin-based composite adhesives with a main component of Bis-GMA, which allows the addition of filler particles to the sealant composition, considerably increasing their wear resistance.7 It is assumed that the residual bacteria in biofilm that remain in the fissure after thorough cleaning, do not survive under a properly applied sealant or cannot multiply if they do survive.13,14 Therefore, the retention rate becomes a determinant of their effectiveness as a caries prevention measure. Otherwise, a partial loss of the sealant material inherently leads to the occurrence of marginal leakage and, hence, to caries development underneath the sealant.15 A sealant is rarely retained completely over the tooth’s lifetime and must be reapplied. It has been previously reported that retention rates of sealant materials at a rate of 74–96%16 and 79–92%6 after one year. There are several possible variables that contribute to the retention of the sealant material, such as; ‘‘enamel properties, surface treatment procedure, and skill of the operator’’.17,18 Undoubtedly, the type of sealant material, its viscosity and flow, as well as the wear resistance of the material are major factors contributing to retention and caries prevention. Several materials and techniques have been developed to enhance the longevity of pit-and-fissure sealants, including the use of flowable composite resins as pit-and-fissure sealants.15,19,20 The use of flowable restorative systems in dentistry has increased, mainly because of their beneficial properties, such as ‘‘low viscosity,21 low modulus of elasticity,21,22 and ease of handling’’.23 These properties may even allow the materials to be successfully placed in ultraconservative preparations with retention rates similar to those of conventional resin pit-and-fissure sealants.19 Although fissure sealants have shown excellent efficacy in prevention of occlusal caries in both children and adolescents,4,6 there seem to be few research studies comparing the retention and caries prevention efficacy on pits and fissures with a flowable resin-based composite in a young population under long-term clinical conditions.
Therefore, the aim of this clinical study was to evaluate the retention rate and caries-prevention effect of a flowable composite pit-and-fissure sealant compared to a fluoride containing conventional resin-based sealant in a young population over a 2-year period. The null hypothesis was that there would be no difference between the flowable composite used as a fissure sealant and resin-based fissure sealant in retention rates and caries-prevention effect in a young population over a 2-year period.
2.
Materials and methods
2.1.
Protocol
The subjects were recruited from patients of Istanbul University, Faculty of Dentistry, Department of Operative Dentistry clinics, who were regularly attending for routine dental care. Thirty-four young patients with a mean age of 20 years (range, 16–22 years), exhibiting at least 2 non-cavitated pit-and-fissure caries on first and second molars, were selected to participate in this randomized, single-blinded, controlled, single-centre split-mouth design trial. The study conformed to good clinical practice (GCP) guidelines, and the research protocol was approved by the Ethical Committee at Istanbul University Faculty of Medicine (project no: 2011/383451). All patients received detailed information (verbal and written) on the principles of treatment, potential discomforts, risks of the procedures, and the study purpose, and signed appropriate informed consent forms. Moreover, the patients were instructed on possible causative factors of pit-andfissure caries, and the multifactorial origin of the caries process.
2.2.
Selection of patients
All patients requesting a routine dental treatment at the Department of Operative Dentistry, Faculty of Dentistry, Istanbul University, who were 16–22 years old (18 male and 16 female patients), in good general health, with at least 2 noncavitated upper/lower first and/or second molar teeth in each quadrant of maxilla or mandible were candidates for inclusion in the study. The patients were not admitted to the study if any of the following criteria were present: (1) known allergy to any of the resins used, (2) clinically detectable caries, (3) previously placed sealants or restorations, (4) bruxism or malocclusion, or (5) residence outside of the city of Istanbul, insufficient address for follow-up, or unwillingness to return for follow-up.
2.3.
Treatment regimen
One specially trained and experienced researcher performed the operative procedures. The fissures of the first and/or second molars were cleaned with a slurry of pumice, applied with a bristle brush in a slow-speed hand piece, to remove salivary pellicles and any remaining plaque. After prophylaxis, teeth were washed with a water spray for 60 s to remove pumice residues. Careful visual inspection was then carried out under good illumination on the clean, dry tooth surfaces with the use of a mirror and a blunt explorer. Occlusal caries
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Table 1 – Type and compositions of the used materials according to the manufacturer data. Material Helioseal F Tetric Evo Flow Excite
Type
Composition
Batch no
Shade
Resin-based fissure sealant Flowable resin-based composite Total-etch single bottle adhesive
Bis-GMA, UDMA, TEGDMA, silicone dioxide, fluorosilicate glass (40.5% wt), titanium dioxide, stabilizers and catalysts ( 0.05) (Table 2).
Table 2 – Distribution of retention rates for fissure sealant and flowable composite. Evaluation
FR n (%) PL n (%) TL n (%) Total no p Values
1-Month
6-Months
12-Months
24-Months
Helioseal F
Tetric Evo Flow
Helioseal F
Tetric Evo Flow
Helioseal F
Tetric Evo Flow
Helioseal F
Tetric Evo Flow
108 (98.1%) 2 (1.9%) 0 (0%) 110 p = 0.156
110 (100%) 0 (0%) 0 (0%) 110
105 (95.5%) 5 (4.5%) 0 (0%) 110 p = 0.985
105 (95.5%) 4 (3.6%) 1 (0.9%) 110
91 (94.8%) 5 (5.2%) 0 (0%) 96 p = 0.985
90 (93.8%) 5 (5.2%) 1 (1%) 96
82 (85.4%) 12 (12.5%) 2 (2.1%) 96 p = 0.244
85 (88.5%) 7 (7.3%) 4 (4.2%) 96
FR, fully retained; PL, partially lost; TL, totally lost.
1 (2.4%) 1 (2.1%) 2 (4.9%) 5 (10.6%) 38 (92.7%) 41 (87.2%) p = 0.309 0 (2.4%) 0 0%) 3 (7.3%) 1 (2.1%) 38 (92.7%) 46 (97.9%) p = 0.256 0 (0%) 0 (0%) 2 (4.1%) 1 (1.9%) 0 (0%) 0 (0%) 1 (2%) 0 (0%) 48 (98%) 54 (100%) p = 0.284 Helioseal F (%) Tetric Evo Flow (%) p Values Lower molars
4.
FR, fully retained; PL, partially lost; TL, totally lost.
TL
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Retention rates of flowable composite and fissure sealants on upper and lower molars at each evaluation period are shown in Table 3. There were no statistically significant differences in retention rates between the materials on the upper and on the lower molars at each evaluation period ( p > 0.05), except for the upper molars at 24-months. The data at 24 months showed that Tetric Evo Flow had significantly better retention than Helioseal F ( p < 0.05). Irrespective of the sealant material, there were no statistically significant differences for FR, PL, TL, and caries incidence at any recall interval between the upper and lower molars ( p > 0.05) (Table 4). Table 5 shows the incidence of new caries lesions throughout the study period with respect to each evaluation parameter according to the ICDAS-II criteria for Caries Associated with Restorations and Sealants scores. No caries were detected adjacent to sealant margins according to the ICDAS-II criteria at the 1- and 6-month recall appointments in any of the sealed teeth (score 0). The incidence of caries in Tetric Evo Flow treated teeth at the 12- and 24-month recall appointments was 4.2% versus 3.1% with Helioseal F treated teeth with representing ICDAS-II scores 1. During the evaluation period, score 2 was not detected adjacent to the sealant margins according to the ICDAS-II criteria in any of the sealant materials used. There were no statistically significant differences between the sealant materials, with respect to the caries prevention ability for each evaluation period ( p > 0.05). Among the Tetric Evo Flow and Helioseal F treated teeth, the caries incidence in the upper molars was higher than in the lower molars. Tetric Evo Flow demonstrated a higher caries incidence than Helioseal F in the upper molars. As shown in Table 6, this difference was not statistically significant at either the 12- or 24-month recall appointments ( p > 0.05). Intra-examiner Kappa values for 1st and 2nd examiners were 90% and 92%, respectively. The inter-examiner Kappa value was 0.85.
47 (95.9%) 53 (98.1%) p = 0.489
10 (18.2%) 2 (4.1%)
PL FR
44 (80%) 44 (89.8%) p = 0.030 0 (0%) 1 (2%)
TL PL
2 (3.6%) 4 (8.2%) 53 (96.4%) 44 (89.8%) p = 0.337
FR TL
0 (0%) 1 (1.8%) 3 (4.9%) 3 (5.4%)
PL FR
58 (95.1%) 52 (92.8%) p = 0.546
TL
0 (0%) 0 (0%)
PL
1 (1.4%) 0 (0%)
FR
60 (98.6%) 56 (100%) p = 0.345 Helioseal F (%) Tetric Evo Flow (%) p Values Upper molars
24-Months 12-Months 6-Months 1-Month Material Location of sealant
Table 3 – Retention rates of fissure sealant and flowable composite on upper and lower molars (%).
1 (1.8%) 3 (6.1%)
journal of dentistry 42 (2014) 149–157
Discussion
Fissure sealants have proven to be highly effective in the prevention of pit-and-fissure caries, due to their penetration, sealing capability, and retention.8,11,12 Since the efficacy of the seal is related to the adhesion to the enamel surface, the retention of a sealing material has become more of interest.25 Literatures have reported that most sealing failures occur within 1 year of application,25,26 and the overall sealant retention rates are estimated to be 74–96%16 and 79–92%6 after one year, which could be considered clinically success. In the present study, retention of a flowable composite fissure sealant, in combination with a total-etch dentine adhesive system, was compared with a fluoride containing resin-based fissure sealant on upper/lower first and second molars in young patients over a 24-month period. The findings of this clinical study support the null hypothesis that there would be no difference between the flowable composite used as a fissure sealant and the resin-based fissure sealant on retention rates and caries-prevention effect in a young population over a 2-year period. The findings of this study also show that the
154
FR, fully retained; PL, partially lost; TL, totally lost; D, decayed.
D TL
4 (3.8%) 2 (2.3%) 12 (11.5%) 7 (7.9%)
PL FR
88 (84.6%) 79 (89.8%) p = 0.384 5 (4.8%) 2 (2.3%) p = 0.526
D TL
1 (0.9%) 0 (0%) 6 (5.8%) 4 (4.5%)
PL FR
97 (93.3%) 84 (95.5%) p = 0.678 0 (0%) 0 (0%) p = 1.000
D TL
1 (0.9%) 0 (0%) 6 (5.1%) 3 (3%)
PL FR
110 (94%) 100 (97%) p = 0.618 0 (0%) 0 (0%) p = 1.000
D TL
0 (0%) 0 (0%) 1 (0.9%) 1 (1%)
PL FR
116 (99.1%) 102 (99%) p = 0.911 Upper molars Lower molars p Values
24-Months 12-Months 6-Months 1-Month Location of sealant
Table 4 – Retention rates and caries incidence of sealant materials on upper and lower molars (%).
5 (4.8%) 2 (2.3%) p = 0.526
journal of dentistry 42 (2014) 149–157
flowable composite material with acid-etching and a respective adhesive system yields high full retention (88.5%) and partial retention rates (7.3%), when compared to conventional resin-based fissure sealant material (85.4% FR and 12.5% PR, respectively), with no significant difference between them at 24 months. In a clinical study, Autio-Gold19 compared the retention rates and caries-prevention effects of a flowable composite with a fissure sealant material, and reported that both materials showed similar retention and caries-prevention effects. However, contrary to our findings, in that study the author reported very low retention rates for flowable composite resin over 18 months and concluded that this occurred because an adhesive system was not used before the flowable composite application. In addition, Dukic´ et al.20 compared the retention and caries-prevention effects of flowable composites and resin-based fissure sealants over 12 months and reported that flowable composites with adhesive systems showed great and durable caries-prevention effects. Similar outcomes have been reported in a metaanalysis,27 and clinical studies15,20,28 have reported that longterm retention rates of flowable composites used as a fissure sealants were comparable to those of conventional pit-andfissure sealants. The slightly better retention rates, in the present study, can be attributed to the properties of the flowable composite because its ‘‘bonding agent’’ leads to the formation of tags after etching with phosphoric acid,4,29 thereby increasing the retention. In addition, flowable composite behaves better mechanically, in terms of wear resistance, when compared to conventional resin-based fissure sealants.4,30 Flowable composite as a fissure sealant on occlusal fissures has shown less surface porosity and better wear resistance, due to a greater amount of filler particles, when compared to conventional fissure sealants.15,19 However, an increase in the amount of filler particles affects the flow characteristics of the material. The flowable composite resin, Tetric Evo Flow, incorporates 62 wt% filler particles. It can be argued that greater amount of filler particles, compared to the resin-based fissure sealant Helioseal F (40.5 wt%), affects the penetration capacity into the deep and shallow fissures. However, Kakaboura et al.31 reported that low-viscosity flowable composite resin can also penetrate the deep and shallow fissures as well as a conventional resin sealant can. Our study supports the retention rates found in previous investigations between the 2 sealant materials.15,19,20 At the beginning of the study, there were no cavitated caries or lesions on the selected molar teeth; however, caries was detected in 4 (4.2%) of the 96 teeth for Tetric Evo Flow treated teeth and 3 (3.1%) of the 96 Helioseal F treated teeth at 12 and 24 months, respectively. This is likely attributed to a total loss of materials leaving the deep fissures exposed32 and/ or a partial loss of the materials’ sharp margins causing microleakage that results in formation of caries under the sealant materials.15,32,33 No statistically significant differences were observed in caries incidence between the sealing materials over the course of the study. We can assume that both sealant materials used in this clinical investigation have shown a caries-prevention effect, as only 7 (3.6%) teeth of 192 sealed teeth showed incidence of caries. Similar to our findings, Pardi et al.28 reported that 4.3% of teeth sealed with
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journal of dentistry 42 (2014) 149–157
Table 5 – Incidence of new caries lesion throughout 24 months according to the ICDAS-II criteria (%). Evaluation (ICDAS-II scores)
0 n (%) 1 n (%) 2 n (%) Total no p Values
6-Months
1-Month
12-Months
24-Months
Helioseal F
Tetric Evo Flow
Helioseal F
Tetric Evo Flow
Helioseal F
Tetric Evo Flow
Helioseal F
Tetric Evo Flow
110 (100%) 0 (0%) 0 (0%) 110 p = 1.000
110 (100%) 0 (0%) 0 (0%) 110
110 (100%) 0 (0%) 0 (0%) 110 p = 1.000
110 (100%) 0 (0%) 0 (0%) 110
93 (96.9%) 3 (3.1%) 0 (0%) 96 p = 0.990
92 (95.8%) 4 (4.2%) 0 (0%) 96
93 (96.9%) 3 (3.1%) 0 (0%) 96 p = 0.990
92 (95.8%) 4 (4.2%) 0 (0%) 96
Table 6 – Distribution of new caries lesion in the upper and lower molars according to the ICDAS-II criteria (%). Location of sealant
Material
1-Month (ICDAS-II score)
6-Months (ICDAS-II score)
12-Months (ICDAS-II score)
24-Months (ICDAS-II score)
0
1
0
1
0
1
0
1
Upper molars
Helioseal F (%) Tetric Evo Flow (%) p Values
61 (100%) 56 (100%) p = 1.000
0 (0%) 0 (0%)
61 (100%) 56 (100%) p = 1.000
0 (0%) 0 (0%)
53 (96.4%) 46 (93.9%) p = 0.890
2 (3.6%) 3 (6.1%)
53 (96.4%) 46 (93.9%) p = 0.890
2 (3.6%) 3 (6.1%)
Lower molars
Helioseal F (%) Tetric Evo Flow (%) p Values
49 (100%) 54 (100%) p = 1.000
0 (0%) 0 (0%)
49 (100%) 54 (100%) p = 1.000
0 (0%) 0 (0%)
40 (97.6%) 46 (97.9%) p = 0.923
1 (2.4%) 1 (2.1%)
40 (97.6%) 46 (97.9%) p = 0.923
1 (2.4%) 1 (2.1%)
flowable composite and 3.1% of teeth sealed with resin-based fissure sealant showed caries after 2 years. In this study, both materials were applied to molar teeth at once. The cariesprevention effect of the materials by this regimen could decrease over time.33,34 Although overall low retention rates were recorded in the Helioseal F group, this group, interestingly, showed a similar caries rates as the Tetric Evo Flow group at all follow-up examinations. This can be explained by the resin-based fissure sealant material releasing more fluoride than the flowable composite material and retention of fissure sealant particles in the bottom of the fissures, resulting in a resistance to demineralization of the enamel.35 Therefore, the retention rate of the sealant material is of great importance in providing a diffusion barrier between the tooth surface and oral environment. The success rate of a sealant material has previously been attributed primarily to the retention of the sealant material.36 During the study period, both the materials showed better retention and caries-prevention effects on the lower molars than on the upper molars. This may be due to several factors such as the flow of the fissure sealant and flowable resin into the deep fissures occurring more easily in the lower molars, the technical sensitivity of the procedure, owing to the visibility of the teeth in the upper jaw,37 and an incorrect positioning of the curing light tip affecting the results.38 In the present study, the retention and caries-prevention effect of a fissure sealant and flowable composite used as a fissure sealant were evaluated in a young population (16–22 years of age). Results showed that applying sealants in this age group is highly effective in preventing caries. In accordance with our findings, Yildiz et al.38 reported that the use of fissure sealant materials in an 18–20-year-old population was highly effective in caries prevention. Feigal32 reported that fissure-sealant caries-prevention procedures can continue into adulthood and that ‘‘any tooth could benefit from sealants at any time’’.32,39
In the present clinical investigation, traditional surface pretreatment, including brushing with a non-fluoride containing prophylactic paste and acid-etching, was used as a standard procedure before sealant material application. In a previous investigation, examiners suggested the use of enameloplasty with steel or diamond burs, and acid-etching, for deeper penetration into the fissure sealant material.40 However, other researchers found no statistically significant differences between enameloplasty and traditional pretreatment procedures.41,42 Therefore, the authors of the present study chose to use traditional surface pretreatment methods, rather than enameloplasty, for the sealant material application. In the present clinical investigation, radiographic examination of the occlusal caries was not performed due to the ethical reasons. Occlusal surfaces traditionally diagnosed by careful visual examination with the use of a blunt explorer under good illumination on the clean, dry tooth surface. If necessary, radiographic examination was only performed for the detection of hidden caries for the purpose of improve the diagnose of occlusal caries.38 The use of rubber-dams for isolation of the operation field is well documented in the literature, and it has been reported that the placement of rubber dams significantly improves sealant retention rates.39,43 However, some investigations have stated that retention rates of fissure sealants and composite resin restorations are similar to those of either rubber dam or cotton roll isolation.44,45 Therefore, in the present study, the operation field was isolated using cotton rolls and a plastic saliva ejector held by an assistant to prevent saliva contamination during the procedure, as previously demonstrated.19 Therefore, no saliva contamination was observed during the application of sealant materials. In the present study, 2 calibrated examiners performed all of the clinical evaluations. The intra- and inter-examiner reliability was calculated using Cohen’s Kappa statistic for
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journal of dentistry 42 (2014) 149–157
the 4 categories (FR, PL, TL, and Caries) and showed high intraand inter-examiner agreement, likely due to training and calibration of the examiners at the beginning of the study.38 A split-mouth design was selected and the selection of the sealant material for each quadrant was randomized. A singleblind evaluation process was selected because of the white opaque shade of the conventional resin-based fissure sealant material. Therefore, only the patients were unaware of the difference.
5.
Conclusions
Within the limitations of the current clinical study, it can be concluded that flowable resin composite material, in conjunction with a total-etch, single-bottle adhesive, showed slightly better retention rates than conventional resin-based fissure sealant over a 24-month period. However, no significant differences were observed between them. Both materials showed similar caries-prevention effects. According to the results at 24 months, flowable composites combined with a total-etch adhesive can be used to seal pits and fissures successfully. Additional long-term clinical investigations are necessary to confirm these results.
references
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12. Locker D, Jokovic A, Kay EJ. Prevention. Part 8: the use of pit and fissure sealants in preventing caries in the permanent dentition of children. British Dental Journal 2003;195:375–8. 13. Mertz-Fairhurst EJ, Schuster GS, Fairhurst CW. Arresting caries by sealants: results of a clinical study. Journal of the American Dental Association 1986;112:194–7. 14. Kervanto-Seppa¨la¨ S, Lavonius E, Pietila¨ I, Pitka¨niemi J, Meurman JH, Kerosuo E. Comparing the caries-preventive effect of two fissure sealing modalities in public health care: a single application of glass ionomer and a routine resinbased sealant programme. A randomized split-mouth clinical trial. International Journal of Paediatric Dentistry 2008;18:56–61. 15. Corona SA, Borsatto MC, Garcia L, Ramos RP, Palma-Dibb RG. Randomized, controlled trial comparing the retention of a flowable restorative system with a conventional resin sealant: one-year follow up. International Journal of Paediatric Dentistry 2005;15:44–50. 16. Beauchamp J, Caufield PW, Crall JJ, Donly K, Feigal R, Gooch B, et al. Evidence-based clinical recommendations for the use of pit-and-fissure sealants: a report of the American Dental Association Council on Scientific Affairs. Journal of the American Dental Association 2008;139:257–68. 17. Holst A, Braune K, Sullivan A. A five-year evaluation of fissure sealants applied by dental assistants. Swedish Dental Journal 1998;22:195–201. 18. Symons AL, Chu CY, Meyers IA. The effect of fissure morphology and pretreatment of the enamel surface on penetration and adhesion of fissure sealants. Journal of Oral Rehabilitation 1996;23:791–8. 19. Autio-Gold JT. Clinical evaluation of a medium-filled flowable restorative material as a pit and fissure sealant. Operative Dentistry 2002;27:325–9. 20. Dukic´ W, Dukic´ OL, Milardovic´ S, Vindakijevic´ Z. Clinical comparison of flowable composite to other fissure sealing materials – a 12 months study. Collegium Antropologicum 2007;31:1019–24. 21. Prager MC. Using flowable composites in direct posterior restorations. Dentistry Today 1997;16:62–9. 22. Labella R, Lambrechts P, Van Meerbeek B, Vanherle G. Polymerization shrinkage and elasticity of flowable composites and filled adhesives. Dental Materials 1999;15:128–37. 23. Murchison DF, Charlton DG, Moore WS. Comparative radiopacity of flowable resin composites. Quintessence International 1999;30:179–84. 24. International Caries Detection and Assessment System (ICDAS) Coordinating Committee. Criteria manual: International Caries Detection and Assessment System (ICDAS II), Bogota, Colombia and Budapest, Hungary. 2009http://www.icdas.org. [accessed September 2010]. 25. Romcke RG, Lewis DW, Maze BD, Vickerson RA. Retention and maintenance of fissure sealants over 10 years. Journal of the Canadian Dental Association 1990;56:235–7. 26. Vrbic V. Retention of a fluoride-containing sealant on primary and permanent teeth 3 years after placement. Quintessence International 1999;30:825–8. 27. Ku¨hnisch J, Mansmann U, Heinrich-Weltzien R, Hickel R. Longevity of materials for pit and fissure sealing – results from a meta-analysis. Dental Materials 2012;28:298–303. 28. Pardi V, Pereira AC, Ambrosano GM, Meneghim M de C. Clinical evaluation of three different materials used as pit and fissure sealant: 24-months results. Journal of Clinical Pediatric Dentistry 2005;29:133–7. 29. Percinoto C, Cunha RF, Delbem AC, Aragones A. Penetration of a light-cured glass ionomer and a resin sealant into occlusal fissures and etched enamel. American Journal of Dentistry 1995;8:20–2.
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30. Attin T, Vataschki M, Hellwig E. Properties of resin-modified glass-ionomer restorative materials and two polyacidmodified resin composite materials. Quintessence International 1996;27:203–9. 31. Kakaboura A, Matthaiou L, Papagiannoulis L. In vitro study of penetration of flowable resin composite and compomer into occlusal fissures. European Journal of Paediatric Dentistry 2002;3:205–9. 32. Feigal RJ. Sealants and preventive restorations: review of effectiveness and clinical changes for improvement. Pediatric Dentistry 1998;20:85–92. 33. Yilmaz Y, Beldu¨z N, Eyu¨boglu O. A two-year evaluation of four different fissure sealants. European Archives of Paediatric Dentistry 2010;11:88–92. 34. Gomez SS, Basili CP, Emilson CG. A 2-year clinical evaluation of sealed noncavitated approximal posterior carious lesions in adolescents. Clinical Oral Investigations 2005;9:239–43. 35. Tanaka M, Ono H, Kadoma Y, Imai Y. Incorporation into human enamel of fluoride slowly released from a sealant in vivo. Journal Dental Research 1987;66:1591–3. 36. Ripa LW. Sealants revisited: an update of the effectiveness of pit-and-fissure sealants. Caries Research 1993;27:77–82. 37. Lygidakis NA, Oulis KI, Christodoulidis A. Evaluation of fissure sealants retention following four different isolation and surface preparation techniques: four years clinical trial dentistry. Journal of Clinical Pediatric 1994;19:23–5.
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38. Yildiz E, Do¨rter C, Efes B, Koray F. A comparative study of two fissure sealants: a 2-year clinical follow-up. Journal of Oral Rehabilitation 2004;31:979–84. 39. Yazici AR, Kiremitc¸i A, Celik C, Ozgu¨naltay G, Dayangac¸ B. A two-year clinical evaluation of pit and fissure sealants placed with and without air abrasion pretreatment in teenagers. Journal of the American Dental Association 2006;137:1401–5. 40. Hatibovic-Kofman S, Butler SA, Sadek H. Microleakage of three sealants following conventional, bur, and air-abrasion preparation of pits and fissures. International Journal of Paediatric Dentistry 2001;11:409–16. 41. Lupi-Pe´gurier L, Muller-Bolla M, Bertrand MF, Fradet T, Bolla M. Microleakage of a pit-and-fissure sealant: effect of airabrasion compared with classical enamel preparations. Journal of Adhesive Dentistry 2004;6:43–8. 42. Blackwood JA, Dilley DC, Roberts MW, Swift Jr EJ. Evaluation of pumice, fissure enameloplasty and air abrasion on sealant microleakage. Pediatric Dentistry 2002;24:199–203. 43. Ganss C, Klimek J, Gleim A. One year clinical evaluation of the retention and quality of two fluoride releasing sealants. Clinical Oral Investigations 1999;3:188–93. 44. Straffon LH, Dennison JB, More FG. Three-year evaluation of sealant: effect of isolation on efficacy. Journal of the American Dental Association 1985;110:714–7. 45. Waggoner WF, Siegal M. Pit and fissure sealant application: updating the technique. Journal of the American Dental Association 1996;127:351–61.
Available online at www.sciencedirect.com
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Clinical comparison of a flowable composite and fissure sealant: A 24-month split-mouth, randomized, and controlled study Ugur Erdemir a,*, Hande Sar Sancakli a, Batu Can Yaman b, Sevda Ozel c, Taner Yucel a, Esra Yıldız a a
Istanbul University, Faculty of Dentistry, Department of Operative Dentistry, 34093 Capa-Istanbul, Turkey Osmangazi University, Faculty of Dentistry, Department of Operative Dentistry, 26480 Eskisehir, Turkey c Istanbul University, Faculty of Medicine, Department of Biostatistics and Medical Informatics, 34093 Capa-Istanbul, Turkey b
article info
abstract
Article history:
Objectives: The aim of this clinical study was to evaluate the retention rate and caries-
Received 23 May 2013
prevention effect of a flowable composite compared to a conventional resin-based sealant in
Received in revised form
a young population over a 24-month period.
18 November 2013
Methods: Thirty-four patients, ranging in age from 16 to 22 years, diagnosed with at least 2
Accepted 21 November 2013
non-cavitated pit-and-fissure caries in the first and second molars were selected for this randomized split-mouth design trial. A total of 220 sealants, were placed in 117 upper molars and 103 lower molars. The teeth were sealed with a flowable resin composite (Tetric
Keywords:
Evo Flow) or a sealant material (Helioseal F). Each restoration was independently evaluated
Fissure caries
in terms of retention and the presence of caries at baseline and at 1, 6, 12, and 24 months.
Fissure sealant
Data were analyzed using non-parametric Mann–Whitney U and Friedman 1-way ANOVA
Flowable composite
tests at p < 0.05.
Clinical study
Results: Tetric Evo Flow showed complete retention with 100%, 95.5%, 93.8%, and 88.5% at 1,
Retention
6, 12, and 24-month evaluations, respectively, while Helioseal F retention rates were 98.1%, 95.5%, 94.8%, and 85.4%, respectively, for the same evaluation periods. At the 24-month recall, 4 (4.2%) total losses were observed in subjects treated with Tetric Evo Flow and 2 total losses (2.1%) for Helioseal F, respectively. No significant differences were observed between the materials in retention rates or caries incidence for each evaluation period ( p > 0.05). Conclusion: Placement of flowable composite as fissure sealants in the younger population seems to be as effective as conventional fluoride containing fissure sealants for the prevention of fissure caries. Clinical relevance: The use of a flowable composite as a fissure sealant material, in conjunction with a total-etch, single bottle adhesive, yielded better retention than did the conventional fluoride containing resin-based fissure sealant over a 24-month period in young patients. # 2013 Elsevier Ltd. All rights reserved.
* Corresponding author. Tel.: +90 212 414 2020x30369; fax: +90 212 525 0075. E-mail addresses: [email protected], [email protected] (U. Erdemir), [email protected] (H.S. Sancakli), [email protected] (B.C. Yaman), [email protected] (S. Ozel), [email protected] (T. Yucel), [email protected] (E. Yıldız). 0300-5712/$ – see front matter # 2013 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jdent.2013.11.015
150
1.
journal of dentistry 42 (2014) 149–157
Introduction
Although the field of dentistry has shown outstanding scientific advances in restorative materials and innovative prevention techniques over recent decades, dental caries remains a highly prevalent pathology worldwide.1,2 Although fluorides are highly effective in preventing caries on smooth surfaces, they are not equally effective in protecting occlusal surfaces.3 Reasons for this include the ‘‘morphology of occlusal pits and fissures that make mechanical cleaning difficult and facilitate the retention of bacteria, nutrients, and debris’’.4 Therefore, a specific barrier between the tooth surface and the oral environment is needed to avoid the development of caries. One of the most appropriate and cost effective treatments for the prevention of occlusal caries in children and adolescents at high risk is the application of pitand-fissure sealants.4–10 Pit-and-fissure sealants were introduced in the 1960s as an efficient caries prevention method and have shown high retention rates.11,12 Most of the sealant materials used today are resin-based composite adhesives with a main component of Bis-GMA, which allows the addition of filler particles to the sealant composition, considerably increasing their wear resistance.7 It is assumed that the residual bacteria in biofilm that remain in the fissure after thorough cleaning, do not survive under a properly applied sealant or cannot multiply if they do survive.13,14 Therefore, the retention rate becomes a determinant of their effectiveness as a caries prevention measure. Otherwise, a partial loss of the sealant material inherently leads to the occurrence of marginal leakage and, hence, to caries development underneath the sealant.15 A sealant is rarely retained completely over the tooth’s lifetime and must be reapplied. It has been previously reported that retention rates of sealant materials at a rate of 74–96%16 and 79–92%6 after one year. There are several possible variables that contribute to the retention of the sealant material, such as; ‘‘enamel properties, surface treatment procedure, and skill of the operator’’.17,18 Undoubtedly, the type of sealant material, its viscosity and flow, as well as the wear resistance of the material are major factors contributing to retention and caries prevention. Several materials and techniques have been developed to enhance the longevity of pit-and-fissure sealants, including the use of flowable composite resins as pit-and-fissure sealants.15,19,20 The use of flowable restorative systems in dentistry has increased, mainly because of their beneficial properties, such as ‘‘low viscosity,21 low modulus of elasticity,21,22 and ease of handling’’.23 These properties may even allow the materials to be successfully placed in ultraconservative preparations with retention rates similar to those of conventional resin pit-and-fissure sealants.19 Although fissure sealants have shown excellent efficacy in prevention of occlusal caries in both children and adolescents,4,6 there seem to be few research studies comparing the retention and caries prevention efficacy on pits and fissures with a flowable resin-based composite in a young population under long-term clinical conditions.
Therefore, the aim of this clinical study was to evaluate the retention rate and caries-prevention effect of a flowable composite pit-and-fissure sealant compared to a fluoride containing conventional resin-based sealant in a young population over a 2-year period. The null hypothesis was that there would be no difference between the flowable composite used as a fissure sealant and resin-based fissure sealant in retention rates and caries-prevention effect in a young population over a 2-year period.
2.
Materials and methods
2.1.
Protocol
The subjects were recruited from patients of Istanbul University, Faculty of Dentistry, Department of Operative Dentistry clinics, who were regularly attending for routine dental care. Thirty-four young patients with a mean age of 20 years (range, 16–22 years), exhibiting at least 2 non-cavitated pit-and-fissure caries on first and second molars, were selected to participate in this randomized, single-blinded, controlled, single-centre split-mouth design trial. The study conformed to good clinical practice (GCP) guidelines, and the research protocol was approved by the Ethical Committee at Istanbul University Faculty of Medicine (project no: 2011/383451). All patients received detailed information (verbal and written) on the principles of treatment, potential discomforts, risks of the procedures, and the study purpose, and signed appropriate informed consent forms. Moreover, the patients were instructed on possible causative factors of pit-andfissure caries, and the multifactorial origin of the caries process.
2.2.
Selection of patients
All patients requesting a routine dental treatment at the Department of Operative Dentistry, Faculty of Dentistry, Istanbul University, who were 16–22 years old (18 male and 16 female patients), in good general health, with at least 2 noncavitated upper/lower first and/or second molar teeth in each quadrant of maxilla or mandible were candidates for inclusion in the study. The patients were not admitted to the study if any of the following criteria were present: (1) known allergy to any of the resins used, (2) clinically detectable caries, (3) previously placed sealants or restorations, (4) bruxism or malocclusion, or (5) residence outside of the city of Istanbul, insufficient address for follow-up, or unwillingness to return for follow-up.
2.3.
Treatment regimen
One specially trained and experienced researcher performed the operative procedures. The fissures of the first and/or second molars were cleaned with a slurry of pumice, applied with a bristle brush in a slow-speed hand piece, to remove salivary pellicles and any remaining plaque. After prophylaxis, teeth were washed with a water spray for 60 s to remove pumice residues. Careful visual inspection was then carried out under good illumination on the clean, dry tooth surfaces with the use of a mirror and a blunt explorer. Occlusal caries
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journal of dentistry 42 (2014) 149–157
Table 1 – Type and compositions of the used materials according to the manufacturer data. Material Helioseal F Tetric Evo Flow Excite
Type
Composition
Batch no
Shade
Resin-based fissure sealant Flowable resin-based composite Total-etch single bottle adhesive
Bis-GMA, UDMA, TEGDMA, silicone dioxide, fluorosilicate glass (40.5% wt), titanium dioxide, stabilizers and catalysts ( 0.05) (Table 2).
Table 2 – Distribution of retention rates for fissure sealant and flowable composite. Evaluation
FR n (%) PL n (%) TL n (%) Total no p Values
1-Month
6-Months
12-Months
24-Months
Helioseal F
Tetric Evo Flow
Helioseal F
Tetric Evo Flow
Helioseal F
Tetric Evo Flow
Helioseal F
Tetric Evo Flow
108 (98.1%) 2 (1.9%) 0 (0%) 110 p = 0.156
110 (100%) 0 (0%) 0 (0%) 110
105 (95.5%) 5 (4.5%) 0 (0%) 110 p = 0.985
105 (95.5%) 4 (3.6%) 1 (0.9%) 110
91 (94.8%) 5 (5.2%) 0 (0%) 96 p = 0.985
90 (93.8%) 5 (5.2%) 1 (1%) 96
82 (85.4%) 12 (12.5%) 2 (2.1%) 96 p = 0.244
85 (88.5%) 7 (7.3%) 4 (4.2%) 96
FR, fully retained; PL, partially lost; TL, totally lost.
1 (2.4%) 1 (2.1%) 2 (4.9%) 5 (10.6%) 38 (92.7%) 41 (87.2%) p = 0.309 0 (2.4%) 0 0%) 3 (7.3%) 1 (2.1%) 38 (92.7%) 46 (97.9%) p = 0.256 0 (0%) 0 (0%) 2 (4.1%) 1 (1.9%) 0 (0%) 0 (0%) 1 (2%) 0 (0%) 48 (98%) 54 (100%) p = 0.284 Helioseal F (%) Tetric Evo Flow (%) p Values Lower molars
4.
FR, fully retained; PL, partially lost; TL, totally lost.
TL
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Retention rates of flowable composite and fissure sealants on upper and lower molars at each evaluation period are shown in Table 3. There were no statistically significant differences in retention rates between the materials on the upper and on the lower molars at each evaluation period ( p > 0.05), except for the upper molars at 24-months. The data at 24 months showed that Tetric Evo Flow had significantly better retention than Helioseal F ( p < 0.05). Irrespective of the sealant material, there were no statistically significant differences for FR, PL, TL, and caries incidence at any recall interval between the upper and lower molars ( p > 0.05) (Table 4). Table 5 shows the incidence of new caries lesions throughout the study period with respect to each evaluation parameter according to the ICDAS-II criteria for Caries Associated with Restorations and Sealants scores. No caries were detected adjacent to sealant margins according to the ICDAS-II criteria at the 1- and 6-month recall appointments in any of the sealed teeth (score 0). The incidence of caries in Tetric Evo Flow treated teeth at the 12- and 24-month recall appointments was 4.2% versus 3.1% with Helioseal F treated teeth with representing ICDAS-II scores 1. During the evaluation period, score 2 was not detected adjacent to the sealant margins according to the ICDAS-II criteria in any of the sealant materials used. There were no statistically significant differences between the sealant materials, with respect to the caries prevention ability for each evaluation period ( p > 0.05). Among the Tetric Evo Flow and Helioseal F treated teeth, the caries incidence in the upper molars was higher than in the lower molars. Tetric Evo Flow demonstrated a higher caries incidence than Helioseal F in the upper molars. As shown in Table 6, this difference was not statistically significant at either the 12- or 24-month recall appointments ( p > 0.05). Intra-examiner Kappa values for 1st and 2nd examiners were 90% and 92%, respectively. The inter-examiner Kappa value was 0.85.
47 (95.9%) 53 (98.1%) p = 0.489
10 (18.2%) 2 (4.1%)
PL FR
44 (80%) 44 (89.8%) p = 0.030 0 (0%) 1 (2%)
TL PL
2 (3.6%) 4 (8.2%) 53 (96.4%) 44 (89.8%) p = 0.337
FR TL
0 (0%) 1 (1.8%) 3 (4.9%) 3 (5.4%)
PL FR
58 (95.1%) 52 (92.8%) p = 0.546
TL
0 (0%) 0 (0%)
PL
1 (1.4%) 0 (0%)
FR
60 (98.6%) 56 (100%) p = 0.345 Helioseal F (%) Tetric Evo Flow (%) p Values Upper molars
24-Months 12-Months 6-Months 1-Month Material Location of sealant
Table 3 – Retention rates of fissure sealant and flowable composite on upper and lower molars (%).
1 (1.8%) 3 (6.1%)
journal of dentistry 42 (2014) 149–157
Discussion
Fissure sealants have proven to be highly effective in the prevention of pit-and-fissure caries, due to their penetration, sealing capability, and retention.8,11,12 Since the efficacy of the seal is related to the adhesion to the enamel surface, the retention of a sealing material has become more of interest.25 Literatures have reported that most sealing failures occur within 1 year of application,25,26 and the overall sealant retention rates are estimated to be 74–96%16 and 79–92%6 after one year, which could be considered clinically success. In the present study, retention of a flowable composite fissure sealant, in combination with a total-etch dentine adhesive system, was compared with a fluoride containing resin-based fissure sealant on upper/lower first and second molars in young patients over a 24-month period. The findings of this clinical study support the null hypothesis that there would be no difference between the flowable composite used as a fissure sealant and the resin-based fissure sealant on retention rates and caries-prevention effect in a young population over a 2-year period. The findings of this study also show that the
154
FR, fully retained; PL, partially lost; TL, totally lost; D, decayed.
D TL
4 (3.8%) 2 (2.3%) 12 (11.5%) 7 (7.9%)
PL FR
88 (84.6%) 79 (89.8%) p = 0.384 5 (4.8%) 2 (2.3%) p = 0.526
D TL
1 (0.9%) 0 (0%) 6 (5.8%) 4 (4.5%)
PL FR
97 (93.3%) 84 (95.5%) p = 0.678 0 (0%) 0 (0%) p = 1.000
D TL
1 (0.9%) 0 (0%) 6 (5.1%) 3 (3%)
PL FR
110 (94%) 100 (97%) p = 0.618 0 (0%) 0 (0%) p = 1.000
D TL
0 (0%) 0 (0%) 1 (0.9%) 1 (1%)
PL FR
116 (99.1%) 102 (99%) p = 0.911 Upper molars Lower molars p Values
24-Months 12-Months 6-Months 1-Month Location of sealant
Table 4 – Retention rates and caries incidence of sealant materials on upper and lower molars (%).
5 (4.8%) 2 (2.3%) p = 0.526
journal of dentistry 42 (2014) 149–157
flowable composite material with acid-etching and a respective adhesive system yields high full retention (88.5%) and partial retention rates (7.3%), when compared to conventional resin-based fissure sealant material (85.4% FR and 12.5% PR, respectively), with no significant difference between them at 24 months. In a clinical study, Autio-Gold19 compared the retention rates and caries-prevention effects of a flowable composite with a fissure sealant material, and reported that both materials showed similar retention and caries-prevention effects. However, contrary to our findings, in that study the author reported very low retention rates for flowable composite resin over 18 months and concluded that this occurred because an adhesive system was not used before the flowable composite application. In addition, Dukic´ et al.20 compared the retention and caries-prevention effects of flowable composites and resin-based fissure sealants over 12 months and reported that flowable composites with adhesive systems showed great and durable caries-prevention effects. Similar outcomes have been reported in a metaanalysis,27 and clinical studies15,20,28 have reported that longterm retention rates of flowable composites used as a fissure sealants were comparable to those of conventional pit-andfissure sealants. The slightly better retention rates, in the present study, can be attributed to the properties of the flowable composite because its ‘‘bonding agent’’ leads to the formation of tags after etching with phosphoric acid,4,29 thereby increasing the retention. In addition, flowable composite behaves better mechanically, in terms of wear resistance, when compared to conventional resin-based fissure sealants.4,30 Flowable composite as a fissure sealant on occlusal fissures has shown less surface porosity and better wear resistance, due to a greater amount of filler particles, when compared to conventional fissure sealants.15,19 However, an increase in the amount of filler particles affects the flow characteristics of the material. The flowable composite resin, Tetric Evo Flow, incorporates 62 wt% filler particles. It can be argued that greater amount of filler particles, compared to the resin-based fissure sealant Helioseal F (40.5 wt%), affects the penetration capacity into the deep and shallow fissures. However, Kakaboura et al.31 reported that low-viscosity flowable composite resin can also penetrate the deep and shallow fissures as well as a conventional resin sealant can. Our study supports the retention rates found in previous investigations between the 2 sealant materials.15,19,20 At the beginning of the study, there were no cavitated caries or lesions on the selected molar teeth; however, caries was detected in 4 (4.2%) of the 96 teeth for Tetric Evo Flow treated teeth and 3 (3.1%) of the 96 Helioseal F treated teeth at 12 and 24 months, respectively. This is likely attributed to a total loss of materials leaving the deep fissures exposed32 and/ or a partial loss of the materials’ sharp margins causing microleakage that results in formation of caries under the sealant materials.15,32,33 No statistically significant differences were observed in caries incidence between the sealing materials over the course of the study. We can assume that both sealant materials used in this clinical investigation have shown a caries-prevention effect, as only 7 (3.6%) teeth of 192 sealed teeth showed incidence of caries. Similar to our findings, Pardi et al.28 reported that 4.3% of teeth sealed with
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journal of dentistry 42 (2014) 149–157
Table 5 – Incidence of new caries lesion throughout 24 months according to the ICDAS-II criteria (%). Evaluation (ICDAS-II scores)
0 n (%) 1 n (%) 2 n (%) Total no p Values
6-Months
1-Month
12-Months
24-Months
Helioseal F
Tetric Evo Flow
Helioseal F
Tetric Evo Flow
Helioseal F
Tetric Evo Flow
Helioseal F
Tetric Evo Flow
110 (100%) 0 (0%) 0 (0%) 110 p = 1.000
110 (100%) 0 (0%) 0 (0%) 110
110 (100%) 0 (0%) 0 (0%) 110 p = 1.000
110 (100%) 0 (0%) 0 (0%) 110
93 (96.9%) 3 (3.1%) 0 (0%) 96 p = 0.990
92 (95.8%) 4 (4.2%) 0 (0%) 96
93 (96.9%) 3 (3.1%) 0 (0%) 96 p = 0.990
92 (95.8%) 4 (4.2%) 0 (0%) 96
Table 6 – Distribution of new caries lesion in the upper and lower molars according to the ICDAS-II criteria (%). Location of sealant
Material
1-Month (ICDAS-II score)
6-Months (ICDAS-II score)
12-Months (ICDAS-II score)
24-Months (ICDAS-II score)
0
1
0
1
0
1
0
1
Upper molars
Helioseal F (%) Tetric Evo Flow (%) p Values
61 (100%) 56 (100%) p = 1.000
0 (0%) 0 (0%)
61 (100%) 56 (100%) p = 1.000
0 (0%) 0 (0%)
53 (96.4%) 46 (93.9%) p = 0.890
2 (3.6%) 3 (6.1%)
53 (96.4%) 46 (93.9%) p = 0.890
2 (3.6%) 3 (6.1%)
Lower molars
Helioseal F (%) Tetric Evo Flow (%) p Values
49 (100%) 54 (100%) p = 1.000
0 (0%) 0 (0%)
49 (100%) 54 (100%) p = 1.000
0 (0%) 0 (0%)
40 (97.6%) 46 (97.9%) p = 0.923
1 (2.4%) 1 (2.1%)
40 (97.6%) 46 (97.9%) p = 0.923
1 (2.4%) 1 (2.1%)
flowable composite and 3.1% of teeth sealed with resin-based fissure sealant showed caries after 2 years. In this study, both materials were applied to molar teeth at once. The cariesprevention effect of the materials by this regimen could decrease over time.33,34 Although overall low retention rates were recorded in the Helioseal F group, this group, interestingly, showed a similar caries rates as the Tetric Evo Flow group at all follow-up examinations. This can be explained by the resin-based fissure sealant material releasing more fluoride than the flowable composite material and retention of fissure sealant particles in the bottom of the fissures, resulting in a resistance to demineralization of the enamel.35 Therefore, the retention rate of the sealant material is of great importance in providing a diffusion barrier between the tooth surface and oral environment. The success rate of a sealant material has previously been attributed primarily to the retention of the sealant material.36 During the study period, both the materials showed better retention and caries-prevention effects on the lower molars than on the upper molars. This may be due to several factors such as the flow of the fissure sealant and flowable resin into the deep fissures occurring more easily in the lower molars, the technical sensitivity of the procedure, owing to the visibility of the teeth in the upper jaw,37 and an incorrect positioning of the curing light tip affecting the results.38 In the present study, the retention and caries-prevention effect of a fissure sealant and flowable composite used as a fissure sealant were evaluated in a young population (16–22 years of age). Results showed that applying sealants in this age group is highly effective in preventing caries. In accordance with our findings, Yildiz et al.38 reported that the use of fissure sealant materials in an 18–20-year-old population was highly effective in caries prevention. Feigal32 reported that fissure-sealant caries-prevention procedures can continue into adulthood and that ‘‘any tooth could benefit from sealants at any time’’.32,39
In the present clinical investigation, traditional surface pretreatment, including brushing with a non-fluoride containing prophylactic paste and acid-etching, was used as a standard procedure before sealant material application. In a previous investigation, examiners suggested the use of enameloplasty with steel or diamond burs, and acid-etching, for deeper penetration into the fissure sealant material.40 However, other researchers found no statistically significant differences between enameloplasty and traditional pretreatment procedures.41,42 Therefore, the authors of the present study chose to use traditional surface pretreatment methods, rather than enameloplasty, for the sealant material application. In the present clinical investigation, radiographic examination of the occlusal caries was not performed due to the ethical reasons. Occlusal surfaces traditionally diagnosed by careful visual examination with the use of a blunt explorer under good illumination on the clean, dry tooth surface. If necessary, radiographic examination was only performed for the detection of hidden caries for the purpose of improve the diagnose of occlusal caries.38 The use of rubber-dams for isolation of the operation field is well documented in the literature, and it has been reported that the placement of rubber dams significantly improves sealant retention rates.39,43 However, some investigations have stated that retention rates of fissure sealants and composite resin restorations are similar to those of either rubber dam or cotton roll isolation.44,45 Therefore, in the present study, the operation field was isolated using cotton rolls and a plastic saliva ejector held by an assistant to prevent saliva contamination during the procedure, as previously demonstrated.19 Therefore, no saliva contamination was observed during the application of sealant materials. In the present study, 2 calibrated examiners performed all of the clinical evaluations. The intra- and inter-examiner reliability was calculated using Cohen’s Kappa statistic for
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the 4 categories (FR, PL, TL, and Caries) and showed high intraand inter-examiner agreement, likely due to training and calibration of the examiners at the beginning of the study.38 A split-mouth design was selected and the selection of the sealant material for each quadrant was randomized. A singleblind evaluation process was selected because of the white opaque shade of the conventional resin-based fissure sealant material. Therefore, only the patients were unaware of the difference.
5.
Conclusions
Within the limitations of the current clinical study, it can be concluded that flowable resin composite material, in conjunction with a total-etch, single-bottle adhesive, showed slightly better retention rates than conventional resin-based fissure sealant over a 24-month period. However, no significant differences were observed between them. Both materials showed similar caries-prevention effects. According to the results at 24 months, flowable composites combined with a total-etch adhesive can be used to seal pits and fissures successfully. Additional long-term clinical investigations are necessary to confirm these results.
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