*1 Senior lecturer, Department of Periodontology and Oral implantology Dasmesh Institute of Research and Dental Sciences, Faridkot(Punjab),India. 2 M.D.S(Senior lecturer) Department of Oral Medicine and Radiology, Swami Devi Dayal Dental College, Barwala, Haryana, India. 3 Retired Professor, Department of Periodontology & Oral Implantology, National Dental College & Hospital, Gulabgarh, Derabassi, Distt. SAS nagar, Mohali (Punjab),India. Abstract: Background: Controlled local delivery of disinfecting agents has been demonstrated to be efficient in improving the outcome of periodontal therapy. Aims: The aim of present study was to evaluate the efficacy of a controlled-release biodegradable chlorhexidine chip (Periocol CG) when used as an adjunct to scaling and root planing in the treatment of periodontitis. Study Design: Study was carried out as randomized controlled two group parallel clinical trial. Material and method: Forty patients in the age group of 30-65 years suffering from chronic periodontitis, having pocket depth ranging between 5-8mm were selected for the study. At screening visit complete history taking, periodontal examination and full mouth supragingival scaling was done for each patient. At baseline visit, all clinical parameters were recorded at selected sites and patients were randomly assigned to either control group (group A) or the treatment group (group B). All patients in the both groups received complete subgingival scaling and root planing. Then in group B, chlorhexidine chip (Periocol CG) was inserted at the selected site. Patients were recalled at 1month, 2 months and 3 months from the baseline for recording clinical observations. Results: There was statistically significant clinical attachment gain, reduction in bleeding index scores and probing pocket depth reduction in both the groups but group B showed better results than group A and these differences were statistically significant. Conclusions: The results of this study show that chlorhexidine chip (PerioCol-CG) is an effective adjunctive therapy to scaling and root planing in the treatment of chronic periodontitis. Keywords: Antimicrobial agents, chlorhexidine chip (Periocol-CG), local drug delivery systems, periodontitis. Introduction: The periodontal diseases represent a group of localized microbial-induced infections involving the gingival and supporting tissues of the teeth. The process of periodontal pocket formation represents the pathological sequel of microbial and inflammatory mediated degradation of collagenous connective tissues and alveolar bone [1] . Recent developments in science and technology have revolutionized the basic outlook and approach to the periodontal disease. A thorough understanding of the etiopathogenesis of periodontal disease has provided the clinicians and researchers with a number of diagnostic tools and techniques that has widened the treatment options [2] .
Conventional periodontal treatment consists of mechanical debridement to eliminate the subgingival microbiota and infected tissue in the inflamed pocket, usually performed by scaling and root planning [3] . The aim of non-surgical periodontal therapy is to eliminate both living bacteria in the microbial biofilm and calcified biofilm microorganisms i.e. dental calculus, from the root surface and from the subgingival area without the surgical reflection of the soft tissues surrounding the teeth [1] . However, deep periodontal pockets, especially with root surface concavities or furcation involvement prevent the effectiveness of scaling and root planing. Consequently, this has led to the adjunctive use of antimicrobials, assuming that chemical aids would compensate for technical limitations and prevent early microbial recolonization to ultimately, ensure the best chance for clinical improvements [4] . Goodson et al. 1979
first proposed the concept of controlled delivery of drug therapy in the treatment of periodontitis [2] . The advantage of this form of therapy is that, it reaches the base of the periodontal pocket and is maintained for an adequate time for the antimicrobial effect to occur. Local administration of antimicrobial drugs directly into the periodontal pocket has been suggested as a means of bypassing systemic complications and targeting localized areas of periodontal destruction. The local concentration achieved can be much higher than is possible by systemic route and there is no Research article ISSN NO- 2230 7885 CODEN JPBSCT NLM Title: J Pharm Biomed Sci.
Dental sciences Bhatia Archana et al. / JPBMS, 2012, 20 (02) 2 Journal of Pharmaceutical and Biomedical Sciences (JPBMS), Vol. 20, Issue 20 dependence on patient compliance for success of the therapy [5] .
Different drugs used for local delivery are tetracyclines including doxycycline [1,6] and minocycline [7] , metronidazole [8,9] and chlorhexidine [10-14] . Of all chemical plaque control agents, chlorhexidine has proven to be the most effective, safe, clinically effective in reducing plaque and gingivitis and is time-tested gold standard for the treatment of periodontal diseases. The aim of the present study was to evaluate the efficacy of a controlled-release biodegradable chlorhexidine chip (Periocol CG) * when used as an adjunct to scaling and root planing in the management of periodontitis.
Subjects and methods: Forty patients (28 males and 12 females) in the age group of 30-65 years suffering from mild to moderate adult periodontitis were selected amongst the patients visiting the Department of Periodontology and Oral Implantology, National Dental College and Hospital, Dera Bassi (Punjab).The study protocol was approved by the institutional ethics committee. The patients were duly informed about the study and their signed consent was obtained.
Inclusion Criteria Patients with probing pocket depth ranging between 5 to 8mm in one or both sides of the arches. Patients with absence of any periapical / pulpal alteration on qualifying teeth. Patients without any history of drug allergy to chlorhexidine. Patients not using any medicated toothpaste/ antibacterial mouthwash / antibiotics or any anti-inflammatory drug before the commencement of study for at least past 3 months. Exclusion Criteria Pregnant / Nursing women. Patients wearing any orthodontic appliance or other restorative appliance which can impinge on the tissues being assessed. Patients on medication that may influence the pattern of tissue response. Patients having soft or hard tissue tumors of the oral cavity. Patients on any drug/ alcohol abuse.
Material: A new preparation of sustained release chlorhexidine (Periocol CG) containing approximately 2.5mg chlorhexidine gluconate in a biodegradable matrix of type I collagen of fish origin was used in this study. The chip measures 4mm in length, 5mm in width and 0.25-0.35mm thickness (4 50.25-0.35 mm) and a single chip weighs about 10 mg. It is self retentive and releases chlorhexidine in vitro, with a release profile of approximately 40-45 % within first 24 hours and there on, in a linear fashion for 7- 8 days. Collagen based membranes are resorbed after 30 days; however their coronal edge degrades within first 10 days. Its shelf life is 2 years.(Fig 1.).
Study Plan:
* Periocol CG, Eucare Pharmaceuticals Pvt Ltd, Chennai, India A Flow chart indicating chronological order of procedures done during study period is shown in Figure 2.For each patient, screening visit was scheduled one week before the baseline visit. At screening visit (1 week before baseline visit) after complete history taking and clinical examination, gingival index and probing pocket depth were recorded and full mouth supragingival scaling was done. At baseline, patients selected at the screening visit returned to the department and were enrolled in the study if they were willing to continue the participation and met the enrolment criteria. Before starting any treatment, all clinical parameters (probing pocket depth, clinical attachment level [15, 16] , bleeding index [17] ) were recorded at selected sites for all the subjects.
Fig 1. sterile collagen periodontal chip with 2.5mg chlorhexidine gluconate (PerioCol-CG)within the box.
Fig 2. Flow chart indicating chronological order of procedures done during study period
Grouping Patients were randomly assigned to one of two groups as follows:- Group A-Scaling and root planing alone (twenty patients) Group B- Scaling and root planing and application of a degradable drug delivery system contains 2.5 mg chlorhexidine (twenty patients). In group A, complete subgingival scaling and root planing was done with hand instruments. In group B, after Dental sciences Bhatia Archana et al. / JPBMS, 2012, 20 (02) 3 Journal of Pharmaceutical and Biomedical Sciences (JPBMS), Vol. 20, Issue 20, complete subgingival scaling and root planing the experimental site was isolated and dried with compressed air for the placement of chlorhexidine chip as a wet chip becomes soft and more difficult to insert. Chlorhexidine chip was carried by using dental forceps, with the round side of the chip facing away from the forceps. At the opening of the periodontal pocket, the round edge was kept along the long axis and chip was inserted into the pocket until resistance was felt (Fig. 3). The patient was permitted to perform normal hygiene procedures, but instructed not to floss for 10 days in the selected sites and adjacent sites at the same interproximal regions to avoid the possibility of chlorhexidine chip dislodgement from the crevice. Patients were also instructed not to use any chemotherapeutic mouth rinse or oral irrigation devices. Patients were recalled for follow up at 1, 2 and 3 months from the baseline for recording clinical parameters. 6.94 6.47 5.89 5.73 5.36 5.26 5.21 4.94 7.36 7.21 7.36 6.89 9.52 9.15 8.47 8.36 0 1 2 3 4 5 6 7 8 9 10 baseline after 1 month after 2 months after 3 months C h a n g e s
f r o m
b a s e l i n e ( m m ) Duration Group B(PD) Group A(PD) group A(CAL) group B(CAL) p value BL to 2M(PD)=0.03** BL to 3 M(PD)=0.44* BL to 2 M(CAL)=0.02** 1M to 2 M(CAL)=0.38*
Fig 3. Line diagram showing comparison of changes in pocket depth and clinical attachment level in both control group (group A) and experimental group (group B)
Results: 40 patients were enrolled in the study but 38 patients (26 males and 12 females) completed the study. Data from two patients who failed to attend an examination during two consecutive time frames were excluded from the study. The mean age of the patients was 38.6 years (range 30-54 years) and there were 28 males (70.0%) and 12 females (30.0%).Male: female ratio was 16:4(M=80.0%,F=20.0%) and 12:8(M=60.0%,F=40.0%)in group A and group B respectively. No statistically significant difference was found between two groups on the basis of cross tabulation of sex groups by using Chi-square test at baseline. A) Probing Pocket Depth: In group A, the mean probing pocket depth of 20 participants at baseline was 5.36+0.59mm and it decreased to 5.26+0.65mm, 5.21+0.71mm and 4.94+0.97mm at 1, 2 and 3 months interval respectively (Table 1). The difference between mean score when put to statistical analysis, was found to be statistically significant only between observations made at baseline and at 3 months interval.
Table 1. Mean values of all the clinical parameters taken during the study in both control group (group A) and experimental (group B)
In group B, the mean probing pocket depth of 20 participants at baseline was 6.94+0.84mm and it decreased to 6.47+0.84mm, 5.89+1.41mm and 5.68+1.60mm at 1, 2 and 3 months interval respectively (Table 1). The difference between mean score when put to statistical analysis was found to be statistically highly significant for the observations made between baseline and 1 month interval and between baseline and 3 months interval (Table 2, Fig. 3).
PD0
PD1
PD2
PD3
CAL0
CAL1
CAL2
CAL3
BI0
BI1
BI2
BI3
Group A Mean 5.36 5.26 5.21 4.94 7.36 7.21 7.36 6.89 1.15 0.94 1.0 0.89 SD 0.59 0.65 0.71 0.97 1.06 1.18 1.11 1.04 0.33 0.55 0.44 0.39
Group B Mean 6.94 6.47 5.89 5.68 9.52 9.15 8.47 8.86 1.28 1.05
0.87 0.89 SD 0.84 0.84 1.41 1.60 0.90 1.01 1.34 1.53 0.41 0.52 0.40 0.48 Dental sciences Bhatia Archana et al. / JPBMS, 2012, 20 (02) 4 Journal of Pharmaceutical and Biomedical Sciences (JPBMS), Vol. 20, Issue 20 Table 2.Comparison of pocket depth changes for both control group (group A) and experimental group (group B) at each recall visit. Paired Samples Test G r o u p
Paired Differences Mean Std. deviation Std. Mean Error 95% confidence interval of the difference T df p - value Result Lower Upper
B PD0 PD1 0.47368 0.61178 0.14035 0.17882 0.76855 3.375 18 0.003 HS PD0 PD2 1.05263 0.91127 0.20906 0.61341 1.49185 5.035 18 0.001 HS PD0 PD3 1.26316 1.19453 0.27404 0.68741 1.83890 4.609 18 0.001 HS PD0 =Pocket depth at baseline PD1=Pocket depth after 1 month PD2=Pocket depth after 2months PD3=Pocket depth after 3 months t =paired t test, df =degree of freedom NS=Non-significant, S=Significant, HS=Highly-significant
B) Clinical Attachment Level: In group A, the mean clinical attachment level of 20 patients at baseline was 7.36+1.06mm. The mean clinical attachment level at 1, 2 and 3 months interval was 7.21+1.18mm, 7.36+1.11mm and 6.89+1.04mm respectively (Table 1). The difference between the mean scores when put to statistical analysis was found to be statistically insignificant between baseline & 1 month interval, baseline & 2 months interval and baseline & 3 months interval. In group B, the mean clinical attachment level of 20 patients at baseline was 9.52+0.90mm. The mean clinical attachment level at 1, 2 and 3 months interval was 9.15+1.01mm, 8.47+1.34mm and 8.86+1.53mm respectively (Table 1). The difference between mean scores when put to statistical analysis was found to be statistically significant at 1 month interval and highly significant at 2 and 3 months interval when compared with observations made at the baseline (Table 3 Figure 3). Table 3. Comparison of change in clinical attachment level for both control group (group A) and experimental group (group B) Paired Samples Test G r o u p Paired Differences Mean Std. deviation Std. Mean Error 95% confidence interval of the difference t df p-value Result Lower Upper
CAL0 =clinical attachment level at baseline, CAL1 =clinical attachment level after 1 month , CAL2 =clinical attachment level after 2 months , CAL3 =clinical attachment level after 3 months t =paired t test df =degree of freedom. NS =Non-significant, S =Significant, HS =Highly-significant.
C) Bleeding index scores: In group A, the mean bleeding index score of 20 patients was 1.15+0.33, 0.94+0.55, 1.0+0.44 and 0.89+0.39 at 0, 1, 2 and 3 months interval respectively (Table 1). The difference between mean scores when put to statistical analysis was found to be statistically significant only at 3 months interval. In group B, the mean bleeding index score of 20 patients was 1.28+0.41, 1.05+0.52, 0.87+0.40 and 0.89+0.48 at 0, 1, 2 and 3 months interval respectively (Table 1). The difference between mean scores when put to statistical analysis was found to be statistically insignificant only at 1 month interval, highly significant at 2 and 3 months interval when compared with baseline readings (Table 4, Fig. 4). Table 4. Comparison of bleeding index score in both control group (group A) and experimental group (group B) Paired Samples Test G r o u p
Paired Differences Mean Std. deviation Std. Mean Error 95% confidence interval of the difference T df p-value Result Lower Upper
Dental sciences Bhatia Archana et al. / JPBMS, 2012, 20 (02) 5 Journal of Pharmaceutical and Biomedical Sciences (JPBMS), Vol. 20, Issue 20, 0.76 0.92 0.88 0.84 0.85 0.76 0.74 0.71 1.15 0.94 1 0.89 1.28 1.05 0.87 0.89 0 0.2 0.4 0.6 0.8 1 1.2 1.4 baseline after 1 month after 2 months after 3 months B l e e d i n g
a n d
p l a q u e
i n d e x
S c o r e Duration group A(PS) group B(PS) group A(BI) group B(BI) p value BL to 2 M(PS)=0.25* BL to 3 M(PS)=0.36*
Fig 4. Line diagram showing comparison of bleeding index (Muhlemann and Sons) in both control group (group A) and experimental group (group B)
PD0 =Pocket depth at baseline, PD1 =Pocket depth after 1 month , PD2 =Pocket depth after 2months, PD3 =Pocket depth after 3 months CAL0 =clinical attachment level at baseline, CAL1 =clinical attachment level after 1 month, CAL2 =clinical attachment level after 2 months , CAL3 =clinical attachment level after 3 months BI0 =bleeding index baseline, BI1=bleeding index after 1 month, BI2 =bleeding index after 2 months ,BI3 =bleeding index after 3months SD =Standard Deviation.
D) Adverse effects: Adverse effects were noted in only 5 subjects of group B and none of the subjects of group A showed any adverse effects due to treatment procedure. The difference between these scores when put to statistical analysis, was found to be statistically significant (Table 5, Fig. 5).
Fig 5. Bar diagramshowing any adverse effects of treatment outcomes in both control group (group A) and experimental group (group B)
Discussion: The present study was undertaken to evaluate the efficacy of subgingivally placed controlled release degradable chlorhexidine chip (Periocol CG) as an adjunct to scaling and root planing in the management of chronic periodontitis. Three months had been selected as the time duration of the study because effects of locally delivered controlled release chlorhexidine have been shown to be evident up to 11 weeks after administration (Soskolne et al. 1983 [18] , Stabolz et al. 1986 [19] ) and 3 months correspond to the typical recall interval for periodontal patients (Jeffcoat et al. 1998 [4] ). Mean reduction in pocket depth from baseline for the duration of the study at one month, two months and three months were 0.10+0.45mm, 0.15+0.60mm and 0.42 +0.76mm respectively for the group A (Scaling and root planing alone group) and 0.47+0.61mm, 1.05+0.91mm and 1.26+1.19mm respectively for the group B (Scaling and root planing plus chlorhexidine chip group) (Table 2). Our results are in accordance with Srinivas et al 2000 [20] and Rodrigues et al. [21] , who found statistically significant difference in mean pocket depth reduction between scaling and root planing group and combination group. According to Soskolne et al 2003 [22] , if after definitive periodontal therapy, there are still residual pockets of 5mm remaining; then combined routine periodontal maintenance therapy along with the chlorhexidine chip is advisable. Clinical attachment gain from the baseline for the duration of study at 1 month, 2 months and three months interval were 0.150.37mm, 0.000.57mm and 0.471.26mm respectively for group A and 0.360.76mm, 1.051.12mm and 1.151.30mm respectively for group B (Table 3). The findings of our study are in partial accordance with Azmak et al. 2002 [3] , he observed a significant improvement in clinical attachment level in both scaling and root planing plus chlorhexidine chip group and scaling and root planing Dental sciences Bhatia Archana et al. / JPBMS, 2012, 20 (02) 6 Journal of Pharmaceutical and Biomedical Sciences (JPBMS), Vol. 20, Issue 20 alone group at one month, three months and at six months as compared to baseline. At the end of the study, the mean change in clinical attachment level from baseline was 0.47+1.26mm for the group A and 1.15+1.30mm for group B (Table 3). These findings are in accordance with Jeffcoat K et al. 2000 [23] ,they observed improved attachment levels over the 9 month period for the scaling and root planing plus chlorhexidine chip group and a significant improvement compared to scaling and root planing alone group at 9 months. Reduction in bleeding index score at one month, two months and three months intervals was 0.210.65, 0.150.55 and 0.260.45 respectively for group A and 0.230.69, 0.420.44 and 0.390.56 respectively for group B as compared to baseline (Table 4). There was statistically significant difference in bleeding index score observed at three months interval in group A and statistically highly significant difference in bleeding index score at two months and at three months interval in group B compared to baseline. These findings are in accordance with Azmak et al. 2002 [3] ,who found a mean reduction in bleeding index score at one month and three months for both combination group and scaling and root planing alone group when compared to baseline. However, at all periods of observations a statistically non-significant correlation was observed in bleeding index score in between the group A and B. About 5 patients (26 %) observed adverse effects like gingival pain and tender gums in group B whereas there was not even a single patient in group A, who observed any side effect due to treatment procedure. Adverse effects occurred in the first week of the study, appeared to be associated with chip placement at baseline after scaling and root planing. None of the changes discovered on oral examination were of a serious and irreversible nature [24].
Conclusion: In conclusion, the results of this study show that chlorhexidine chip containing 2.5 mg chlorhexidine gluconate (Periocol CG) is an effective adjunctive therapy to scaling and root planing in the treatment of chronic periodontitis. It provides a safe, easily applied single dose means of achieving significant better clinical results than scaling and root planing alone. The adjunctive use of the chlorhexidine chip with scaling and root planing resulted in a clinically meaningful improvement in pocket depth reduction and clinical attachment level gain compared to scaling and root planing alone.
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Source of funding:- None Conflict of interest:-Not declared.
Corresponding Author:- Dr. Bhatia Archana., Senior lecturer, Department of Periodontology and Oral implantology, Dasmesh Institute of Research and Dental Sciences Faridkot (Punjab), India. Contact no.+91-9888370446
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