J Clin Periodontol 2014; 41: 157–163 doi: 10.1111/jcpe.12199
One-stage full-mouth disinfection combined with a periodontal dressing: a randomized controlled clinical trial
Johan A. J. Keestra1, Wim Coucke2 and Marc Quirynen1 1
Department of Periodontology, School of Dentistry, Oral Pathology & Maxillo-facial Surgery, Faculty of Medicine, Catholic University Leuven, Leuven, Belgium; 2 Department of Clinical Biology, Scientific Institute of Public Health, Brussels, Belgium
Keestra JAJ, Coucke W, Quirynen M. One-stage full-mouth disinfection combined with a periodontal dressing: a randomized controlled clinical trial. J Clin Periodontol 2014; 41: 157–163. doi: 10.1111/jcpe.12199.
Abstract Aim: To compare the clinical benefit of a periodontal dressing applied after a one-stage full-mouth disinfection (OSFMD) in patients with chronic periodontitis up to 3 months after therapy. Material and Methods: This randomized, controlled split-mouth study included 24 patients. After OSFMD, a test and a control side were selected by means of a computer-generated randomization list. Test sides received a periodontal dressing (Coepakâ) for 7 days and the control sides received no periodontal dressing. After 7 days the periodontal dressing was removed and the pain experience was recorded. After 3 months, the clinical periodontal parameters were recorded. Results: The periodontal dressing group showed a significant (p < 0.05) additional pocket depth reduction and additional clinical attachment gain for the moderate pockets of single- and multi-rooted teeth compared with the control group. A significant (p < 0.05) lower percentage of sites with probing pocket depth ≥5 mm were shown for the periodontal dressing group compared with the control group (2.7 16.3% versus 4.8 21.4%). The pain intensity was significantly reduced when using a periodontal dressing (5.13 0.89 versus 3.42 1.27). Conclusion: The use of a periodontal dressing for 7 days after a OSFMD offers an additional short-term clinical improvement and lowers the pain intensity.
Periodontitis is an inflammatory disease that results in the destruction of the teeth-supporting tissues. It is a result of an imbalance between the wide range of microorganisms, the host response and some essential Conflict of interest and source of funding statement This article has been prepared without any sources of institutional, private or corporate financial support, and there are no potential conflicts of interest.
modifying factors (Socransky & Haffajee 1992). The primary clinical signs are bleeding on probing (BOP), pocket formation (PPD), gingival recession (REC) and at a later stage increased tooth mobility. The goals of treatment are to reduce the infection, resolve inflammation and create a clinical condition, which is compatible with periodontal health (Lang & Tonetti 2003). It has been shown that non-surgical periodontal therapy, consisting of scaling and root planing, results
© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Key words: chronic periodontitis; full-mouth disinfection; non-surgical therapy; periodontal dressing Accepted for publication 17 November 2013
in clinical improvements (Badersten et al. 1981). This is usually done in a quadrant wise approach (QSRP). In 1995 Quirynen and co-workers introduced the one-stage full-mouth disinfection (OSFMD). With this procedure scaling and root planing was performed in two sessions within 24 h and was supplemented with supra- and subgingival use of chlorhexidine (Quirynen et al. 1995, 2006, Mongardini et al. 1999). Periodontal dressings were introduced in 1923 in order to protect
157
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Keestra et al.
wounds after periodontal surgery (Ward 1923). Nowadays, it is still used after resective periodontal surgery as well as after recession coverage. The periodontal dressing protects the tissue and keeps the tissue in close contact with the teeth. It stabilizes the coagulum and protects it from different forces during talking and eating (Wikesj€ o et al. 1992). Wound healing is a complex process involving different phases such as; homeostasis phase, inflammatory phase, proliferation and remodelling phase (Stadelmann et al. 1998). The first and most important step is the formation of a fibrin clot. This clot will protect the wound and attract inflammatory cells. When a tissue is wounded, platelets start to release inflammatory factors, cytokines and growth factors to facilitate the healing (Barrientos et al. 2008). When all the steps are successfully accomplished, the healing will result in reduction of the swelling, recession of the gingival margin due to resolution of inflammation and formation of long junctional epithelium. Sigusch et al. (2005) introduced the use of a periodontal dressing as an adjunctive tool for the treatment of patients with aggressive periodontitis. The group with the periodontal dressing applied for 7 days showed a significant pocket reduction and clinical attachment gain compared with the control group. Genovesi et al. (2012) applied a periodontal dressing for 7 days after non-surgical therapy for the treatment of patients with moderate-to-advanced periodontitis. The results were similar to the results of Sigusch et al. (2005). The aim of this randomized clinical trial was to evaluate, in a splitmouth design, the effect of a periodontal dressing applied for 7 days after OSFMD. Material and Methods
This study was designed as a randomized-controlled split-mouth trial to compare the clinical effects of two different periodontal treatments, OSFMD alone or combined with a periodontal dressing for 7 days with a 3 months follow-up period. The ethical committee at the University Hospital Leuven approved the protocol. All participants had to sign an informed consent before entering the
Fig. 1. Study design.
study. The study started in September 2010 and ended in June 2012. Twenty-six volunteers were selected for this prospective study (Fig. 1). All patients consulted or were referred to the Department of Periodontology of the University Hospitals Leuven for the treatment of chronic periodontitis. The general health of all the patients was good. The following inclusion/exclusion criteria had to be fulfilled:
•
• •
Inclusion criteria
• • • • •
Age between 30 and 75 years. A minimum of 18 teeth, wisdom teeth excluded. Previously untreated moderate chronic periodontitis (Armitage 1999) with radiographic evidence of generalized alveolar bone loss >30%. Presence of at least one pocket with probing pocket depth (PPD) ≥6 mm per quadrant, which was BOP. Presence of at least three teeth per quadrant.
Exclusion criteria
• • • •
Periodontal treatment in the last 3 years. Antibiotic intake 6 months before the screening visit. Pregnancy. Systemic diseases with an impact on periodontal healing (e.g. Diabetes).
The purpose of the study was explained to the patients who met the inclusion criteria and they were asked to participate by signing an informed consent form. The following clinical parameters (in sequential order) were recorded by only one trained and calibrated periodontist (J.K.).
•
•
The plaque score (PS) was detected visually or with the probe at 4 sites per tooth (mesial, distal, buccal and lingual); the scores ranged from 0 (absent) to 1 (present) (O’Leary et al. 1972). The PPD was recorded to the nearest 0.5 mm at six sites per single-rooted teeth and ten sites for multi-rooted teeth. The amount of gingival recession (REC, the distance from the cemento-enamel junction to the gingival margin) was measured to the nearest 0.5 mm at the same sites as the PPD. The BOP was evaluated 30 s after probing in the depth of the pockets at four sites per tooth (mesial, distal, buccal and lingual); the scores ranged from 0 (absent) to 1 (present). The clinical attachment level (CAL) was calculated for each site as the sum of the PPD and the REC.
These variables were recorded using the Merritt B probe (Hu-Friedy, Chicago, IL, USA). After the clinical examination, oral hygiene instructions were given (the modified-Bass technique, interdental cleaning and tongue scraping in the case of tongue coating). After 1 or 2 weeks OSFMD was performed by one periodontist (J.K.). Scaling and root planing using ultrasonic and hand instruments was performed in two sessions within 24 h and was supplemented with:
• • • •
Tongue brushing (by the patient) for 60 s with chlorhexidine 1% gel. Rinsing twice with a chlorhexidine 0.12% solution for 1 min. Spraying the pharynx with a 0.12% chlorhexidine spray. Subgingival irrigation of all the pockets three times within
© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
159
Full-mouth disinfection with periodontal dressing 10 min. with the chlorhexidine 1% gel using a syringe (the tip of the needle was blunted so that the resistance offered by the bottom of the pocket could be felt).
difference between the two treatments. Treatment was used as a fixed factor. Position, tooth number and patient were used as nested random factors. Normal quantile plots and residual dot plots were used to assess the normality and variability distribution of the data and did not indicate any deviation from the basic assumptions. Significance was determined by using an a of 0.05; p-values lower than 0.05 were considered significant. S-Plus 7 (Tibco, Palo Alto, CA, USA) was used for the statistical analyses.
pared with the control group the test group showed a significant reduction of the pain intensity, which was 1.71 (p < 0.0001). The mean values for PPD, REC and CAL are presented in Table 2. The control group showed a significant reduction of the PPD with 1.20 mm (p = 0.0001) and CAL with 0.74 mm (p = 0.0001) compared to the baseline. The test group also showed a significant reduction of the PPD with 1.49 mm (p = 0.0001) and CAL with 1.01 mm (p = 0.0001) compared to the baseline. The test group showed a significantly higher reduction of the PPD with 0.29 (p < 0.0001) mm and CAL with 0.26 mm (p < 0.0001). The control group showed a significant increase of the REC with 0.45 mm (p = 0.0001) compared to the baseline. The test group also showed a significant increase of the REC with 0.48 mm (p = 0.0001) compared to the baseline. The test group showed no significant difference of the REC. Those three clinical parameters were also divided into moderate pockets (4–6 mm) and deep pockets (>6 mm). The control group showed a significant reduction of the PPD of the moderate pockets with 1.87 mm (p = 0.0018) and for the deep pockets 3.27 mm (p = 0.0018). The significant reduction was also seen for the CAL of the moderate pockets with 1.20 mm (p = 0.0018) and for the deep pockets 1.83 mm (p = 0.0018) compared to the baseline. The test group also showed a significant reduction of the PPD of the moderate pockets with 2.20 mm (p = 0.0018) and for the deep pockets 3.56 mm (p = 0.0018). Again the significant reduction was also seen for the CAL of the moderate pockets with 1.53 mm (p = 0.0018) and for the deep pockets 2.10 mm (p =
Additionally, the patients had to rinse twice daily for 1 min. with a 0.12% chlorhexidine solution for 2 months (Quirynen et al. 1995, 2006, Mongardini et al. 1999). The first treatment was started at the right side (first and fourth quadrant). At the end of the first treatment, a test and control side was selected by means of a computergenerated randomization list. If the first quadrant was selected as the test side, the third quadrant was selected after the second treatment as the test side. Hereby, the periodontal dressing was always placed in one upper and one lower quadrant. The operator (J.K.) mixed the periodontal dressing (Coepakâ, Alsip, IL, USA) according to the manufacturer’s instructions. The oral hygiene instructions were given and each patient had to avoid brushing the periodontal dressing area as long as the periodontal dressing was in place. After 1 week, the periodontal dressing was removed from the test sides and oral hygiene instructions were repeated, identical to the first time. The patients had to compare the difference between the sides with the periodontal dressing and the sides without the periodontal dressing. During this appointment the patients had to fill out a pain intensity scale on a scale from 0 to 10 (0 = no pain, 5 = moderate pain and 10 = worst imaginable pain) and the amount of pain medication was recorded. After 3 months, all clinical examinations were recorded by only one trained and calibrated periodontist (J.K.).
Twenty-six patients passed the inclusion / exclusion criteria. Two patients were excluded because they did not show up at the final appointment after 3 months. Finally, a total of twenty-four patients were statistically analysed. Table 1 presents the demographic characteristics. All patients belonged to the Caucasian race with an average age of 48.3 (range 33–64 years). The total number of teeth and mean percentage of sites (with PPD < 4 mm, PPD 4–6 mm and PPD > 6 mm) were equally distributed. The mean values for PS and BOP are presented in Table 2. The control group showed a significant reduction of the PS with 37% (p = 0.0001) and BOP with 39% (p = 0.0001) compared to the baseline. The test group also showed a significant reduction of the PS with 48% (p = 0.0001) and BOP with 51% (p = 0.0001) compared to the baseline. The test group showed a significantly higher reduction of the PS with 11% (p < 0.0001) and BOP with 12% (p < 0.0001). The pain sensation was measured 7 days after OSFMD, the results are presented in Table 2. When com-
Statistical analyses
Table 1. Demographic characteristics and mean SD full-mouth clinical parameters
A power analysis was carried out. Based on these calculations, it was defined that 22 patients would be necessary. Considering a drop out of about 15%, it was established that at least 25 patients were needed. The concordance correlation coefficient was used to quantify the degree of agreement or congruence between two measurements. Linear mixed models were fit to assess the
Results
Variable Gender (male/female) Age (years) Smokers (n) Total tooth (n) Multi rooted (n) Single-rooted (n) Mean % (number) of sites with PPD 6 mm
© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Control
Test
13/11 48.4 9.2 0 304 79 225
13/11 48.4 9.2 0 303 79 224
57.4 49.5 36.1 48 6.5 24.7
54.9 48.8 37.4 48.4 7.8 26.8
BOP, bleeding on probing; CAL, clinical attachment level; PPD, probing pocket depth; PS, plaque score; REC, gingival recession; SE, standard error; SD, standard deviation.
0.4000 0.12 0.0018 7.71
1.00
5.93
1.19
1.83
0.13
0.0018
7.72
1.22
5.78
1.37
2.10
0.13
0.27
>0.9999
One-stage full-mouth disinfection combined with a periodontal dressing: a randomized controlled clinical trial
Johan A. J. Keestra1, Wim Coucke2 and Marc Quirynen1 1
Department of Periodontology, School of Dentistry, Oral Pathology & Maxillo-facial Surgery, Faculty of Medicine, Catholic University Leuven, Leuven, Belgium; 2 Department of Clinical Biology, Scientific Institute of Public Health, Brussels, Belgium
Keestra JAJ, Coucke W, Quirynen M. One-stage full-mouth disinfection combined with a periodontal dressing: a randomized controlled clinical trial. J Clin Periodontol 2014; 41: 157–163. doi: 10.1111/jcpe.12199.
Abstract Aim: To compare the clinical benefit of a periodontal dressing applied after a one-stage full-mouth disinfection (OSFMD) in patients with chronic periodontitis up to 3 months after therapy. Material and Methods: This randomized, controlled split-mouth study included 24 patients. After OSFMD, a test and a control side were selected by means of a computer-generated randomization list. Test sides received a periodontal dressing (Coepakâ) for 7 days and the control sides received no periodontal dressing. After 7 days the periodontal dressing was removed and the pain experience was recorded. After 3 months, the clinical periodontal parameters were recorded. Results: The periodontal dressing group showed a significant (p < 0.05) additional pocket depth reduction and additional clinical attachment gain for the moderate pockets of single- and multi-rooted teeth compared with the control group. A significant (p < 0.05) lower percentage of sites with probing pocket depth ≥5 mm were shown for the periodontal dressing group compared with the control group (2.7 16.3% versus 4.8 21.4%). The pain intensity was significantly reduced when using a periodontal dressing (5.13 0.89 versus 3.42 1.27). Conclusion: The use of a periodontal dressing for 7 days after a OSFMD offers an additional short-term clinical improvement and lowers the pain intensity.
Periodontitis is an inflammatory disease that results in the destruction of the teeth-supporting tissues. It is a result of an imbalance between the wide range of microorganisms, the host response and some essential Conflict of interest and source of funding statement This article has been prepared without any sources of institutional, private or corporate financial support, and there are no potential conflicts of interest.
modifying factors (Socransky & Haffajee 1992). The primary clinical signs are bleeding on probing (BOP), pocket formation (PPD), gingival recession (REC) and at a later stage increased tooth mobility. The goals of treatment are to reduce the infection, resolve inflammation and create a clinical condition, which is compatible with periodontal health (Lang & Tonetti 2003). It has been shown that non-surgical periodontal therapy, consisting of scaling and root planing, results
© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Key words: chronic periodontitis; full-mouth disinfection; non-surgical therapy; periodontal dressing Accepted for publication 17 November 2013
in clinical improvements (Badersten et al. 1981). This is usually done in a quadrant wise approach (QSRP). In 1995 Quirynen and co-workers introduced the one-stage full-mouth disinfection (OSFMD). With this procedure scaling and root planing was performed in two sessions within 24 h and was supplemented with supra- and subgingival use of chlorhexidine (Quirynen et al. 1995, 2006, Mongardini et al. 1999). Periodontal dressings were introduced in 1923 in order to protect
157
158
Keestra et al.
wounds after periodontal surgery (Ward 1923). Nowadays, it is still used after resective periodontal surgery as well as after recession coverage. The periodontal dressing protects the tissue and keeps the tissue in close contact with the teeth. It stabilizes the coagulum and protects it from different forces during talking and eating (Wikesj€ o et al. 1992). Wound healing is a complex process involving different phases such as; homeostasis phase, inflammatory phase, proliferation and remodelling phase (Stadelmann et al. 1998). The first and most important step is the formation of a fibrin clot. This clot will protect the wound and attract inflammatory cells. When a tissue is wounded, platelets start to release inflammatory factors, cytokines and growth factors to facilitate the healing (Barrientos et al. 2008). When all the steps are successfully accomplished, the healing will result in reduction of the swelling, recession of the gingival margin due to resolution of inflammation and formation of long junctional epithelium. Sigusch et al. (2005) introduced the use of a periodontal dressing as an adjunctive tool for the treatment of patients with aggressive periodontitis. The group with the periodontal dressing applied for 7 days showed a significant pocket reduction and clinical attachment gain compared with the control group. Genovesi et al. (2012) applied a periodontal dressing for 7 days after non-surgical therapy for the treatment of patients with moderate-to-advanced periodontitis. The results were similar to the results of Sigusch et al. (2005). The aim of this randomized clinical trial was to evaluate, in a splitmouth design, the effect of a periodontal dressing applied for 7 days after OSFMD. Material and Methods
This study was designed as a randomized-controlled split-mouth trial to compare the clinical effects of two different periodontal treatments, OSFMD alone or combined with a periodontal dressing for 7 days with a 3 months follow-up period. The ethical committee at the University Hospital Leuven approved the protocol. All participants had to sign an informed consent before entering the
Fig. 1. Study design.
study. The study started in September 2010 and ended in June 2012. Twenty-six volunteers were selected for this prospective study (Fig. 1). All patients consulted or were referred to the Department of Periodontology of the University Hospitals Leuven for the treatment of chronic periodontitis. The general health of all the patients was good. The following inclusion/exclusion criteria had to be fulfilled:
•
• •
Inclusion criteria
• • • • •
Age between 30 and 75 years. A minimum of 18 teeth, wisdom teeth excluded. Previously untreated moderate chronic periodontitis (Armitage 1999) with radiographic evidence of generalized alveolar bone loss >30%. Presence of at least one pocket with probing pocket depth (PPD) ≥6 mm per quadrant, which was BOP. Presence of at least three teeth per quadrant.
Exclusion criteria
• • • •
Periodontal treatment in the last 3 years. Antibiotic intake 6 months before the screening visit. Pregnancy. Systemic diseases with an impact on periodontal healing (e.g. Diabetes).
The purpose of the study was explained to the patients who met the inclusion criteria and they were asked to participate by signing an informed consent form. The following clinical parameters (in sequential order) were recorded by only one trained and calibrated periodontist (J.K.).
•
•
The plaque score (PS) was detected visually or with the probe at 4 sites per tooth (mesial, distal, buccal and lingual); the scores ranged from 0 (absent) to 1 (present) (O’Leary et al. 1972). The PPD was recorded to the nearest 0.5 mm at six sites per single-rooted teeth and ten sites for multi-rooted teeth. The amount of gingival recession (REC, the distance from the cemento-enamel junction to the gingival margin) was measured to the nearest 0.5 mm at the same sites as the PPD. The BOP was evaluated 30 s after probing in the depth of the pockets at four sites per tooth (mesial, distal, buccal and lingual); the scores ranged from 0 (absent) to 1 (present). The clinical attachment level (CAL) was calculated for each site as the sum of the PPD and the REC.
These variables were recorded using the Merritt B probe (Hu-Friedy, Chicago, IL, USA). After the clinical examination, oral hygiene instructions were given (the modified-Bass technique, interdental cleaning and tongue scraping in the case of tongue coating). After 1 or 2 weeks OSFMD was performed by one periodontist (J.K.). Scaling and root planing using ultrasonic and hand instruments was performed in two sessions within 24 h and was supplemented with:
• • • •
Tongue brushing (by the patient) for 60 s with chlorhexidine 1% gel. Rinsing twice with a chlorhexidine 0.12% solution for 1 min. Spraying the pharynx with a 0.12% chlorhexidine spray. Subgingival irrigation of all the pockets three times within
© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
159
Full-mouth disinfection with periodontal dressing 10 min. with the chlorhexidine 1% gel using a syringe (the tip of the needle was blunted so that the resistance offered by the bottom of the pocket could be felt).
difference between the two treatments. Treatment was used as a fixed factor. Position, tooth number and patient were used as nested random factors. Normal quantile plots and residual dot plots were used to assess the normality and variability distribution of the data and did not indicate any deviation from the basic assumptions. Significance was determined by using an a of 0.05; p-values lower than 0.05 were considered significant. S-Plus 7 (Tibco, Palo Alto, CA, USA) was used for the statistical analyses.
pared with the control group the test group showed a significant reduction of the pain intensity, which was 1.71 (p < 0.0001). The mean values for PPD, REC and CAL are presented in Table 2. The control group showed a significant reduction of the PPD with 1.20 mm (p = 0.0001) and CAL with 0.74 mm (p = 0.0001) compared to the baseline. The test group also showed a significant reduction of the PPD with 1.49 mm (p = 0.0001) and CAL with 1.01 mm (p = 0.0001) compared to the baseline. The test group showed a significantly higher reduction of the PPD with 0.29 (p < 0.0001) mm and CAL with 0.26 mm (p < 0.0001). The control group showed a significant increase of the REC with 0.45 mm (p = 0.0001) compared to the baseline. The test group also showed a significant increase of the REC with 0.48 mm (p = 0.0001) compared to the baseline. The test group showed no significant difference of the REC. Those three clinical parameters were also divided into moderate pockets (4–6 mm) and deep pockets (>6 mm). The control group showed a significant reduction of the PPD of the moderate pockets with 1.87 mm (p = 0.0018) and for the deep pockets 3.27 mm (p = 0.0018). The significant reduction was also seen for the CAL of the moderate pockets with 1.20 mm (p = 0.0018) and for the deep pockets 1.83 mm (p = 0.0018) compared to the baseline. The test group also showed a significant reduction of the PPD of the moderate pockets with 2.20 mm (p = 0.0018) and for the deep pockets 3.56 mm (p = 0.0018). Again the significant reduction was also seen for the CAL of the moderate pockets with 1.53 mm (p = 0.0018) and for the deep pockets 2.10 mm (p =
Additionally, the patients had to rinse twice daily for 1 min. with a 0.12% chlorhexidine solution for 2 months (Quirynen et al. 1995, 2006, Mongardini et al. 1999). The first treatment was started at the right side (first and fourth quadrant). At the end of the first treatment, a test and control side was selected by means of a computergenerated randomization list. If the first quadrant was selected as the test side, the third quadrant was selected after the second treatment as the test side. Hereby, the periodontal dressing was always placed in one upper and one lower quadrant. The operator (J.K.) mixed the periodontal dressing (Coepakâ, Alsip, IL, USA) according to the manufacturer’s instructions. The oral hygiene instructions were given and each patient had to avoid brushing the periodontal dressing area as long as the periodontal dressing was in place. After 1 week, the periodontal dressing was removed from the test sides and oral hygiene instructions were repeated, identical to the first time. The patients had to compare the difference between the sides with the periodontal dressing and the sides without the periodontal dressing. During this appointment the patients had to fill out a pain intensity scale on a scale from 0 to 10 (0 = no pain, 5 = moderate pain and 10 = worst imaginable pain) and the amount of pain medication was recorded. After 3 months, all clinical examinations were recorded by only one trained and calibrated periodontist (J.K.).
Twenty-six patients passed the inclusion / exclusion criteria. Two patients were excluded because they did not show up at the final appointment after 3 months. Finally, a total of twenty-four patients were statistically analysed. Table 1 presents the demographic characteristics. All patients belonged to the Caucasian race with an average age of 48.3 (range 33–64 years). The total number of teeth and mean percentage of sites (with PPD < 4 mm, PPD 4–6 mm and PPD > 6 mm) were equally distributed. The mean values for PS and BOP are presented in Table 2. The control group showed a significant reduction of the PS with 37% (p = 0.0001) and BOP with 39% (p = 0.0001) compared to the baseline. The test group also showed a significant reduction of the PS with 48% (p = 0.0001) and BOP with 51% (p = 0.0001) compared to the baseline. The test group showed a significantly higher reduction of the PS with 11% (p < 0.0001) and BOP with 12% (p < 0.0001). The pain sensation was measured 7 days after OSFMD, the results are presented in Table 2. When com-
Statistical analyses
Table 1. Demographic characteristics and mean SD full-mouth clinical parameters
A power analysis was carried out. Based on these calculations, it was defined that 22 patients would be necessary. Considering a drop out of about 15%, it was established that at least 25 patients were needed. The concordance correlation coefficient was used to quantify the degree of agreement or congruence between two measurements. Linear mixed models were fit to assess the
Results
Variable Gender (male/female) Age (years) Smokers (n) Total tooth (n) Multi rooted (n) Single-rooted (n) Mean % (number) of sites with PPD 6 mm
© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Control
Test
13/11 48.4 9.2 0 304 79 225
13/11 48.4 9.2 0 303 79 224
57.4 49.5 36.1 48 6.5 24.7
54.9 48.8 37.4 48.4 7.8 26.8
BOP, bleeding on probing; CAL, clinical attachment level; PPD, probing pocket depth; PS, plaque score; REC, gingival recession; SE, standard error; SD, standard deviation.
0.4000 0.12 0.0018 7.71
1.00
5.93
1.19
1.83
0.13
0.0018
7.72
1.22
5.78
1.37
2.10
0.13
0.27
>0.9999
