|Year : 2018 | Volume
| Issue : 6 | Page : 523-528
Comparison of clinical effectiveness of single and multiple applications of 1% chlorhexidine varnish (Cervitec Plus) along with scaling and root planing in patients with chronic periodontitis
Sonia Sachdeva1, Vishakha Grover2, Ranjan Malhotra3, Anoop Kapoor4, Kanishk Mohanty1
1 Sai Dental Clinic and Implant Centre, Jalandhar, Punjab, India
2 Department of Periodontology and Oral Implantology, Dr. H. S. J. Institute of Dental Sciences and Hospital, Punjab University, Chandigarh, India
3 Department of Periodontology and Oral Implantology, Himachal Dental College and Hospital, Sundernagar, Himachal Pradesh, India
4 Department of Periodontology and Oral Implantology, Sri Sukhmani Dental College and Hospital, Dera Bassi, Punjab, India
|Date of Submission||15-Apr-2018|
|Date of Acceptance||25-Jun-2018|
|Date of Web Publication||1-Nov-2018|
Dr. Vishakha Grover
3192, Ground Floor, Sector 37-D, Chandigarh
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: Local drug delivery is most commonly used as an adjunct to scaling and root planing (SRP) for the treatment of periodontal disease. Varied success rates have been documented for various vehicles used for intrasite delivery of active therapeutic agents. Recently, varnishes acting as a reservoir of chlorhexidine have shown potential for the management of chronic periodontitis patients. The aim of the present investigation was a comparative evaluation of the clinical effectiveness of single and multiple applications of 1% chlorhexidine and thymol varnish (Cervitec Plus) along with SRP in patients with chronic periodontitis. Materials and Methods: The present study included 30 patients with chronic periodontitis divided into three groups based on the number of subgingival applications of chlorhexidine varnish single application (Group A), two applications at a week's interval (Group B), and three applications with 7-day interval in between two applications (Group C). Clinical parameters, namely plaque index (PI), sulcus bleeding index, probing pocket depth (PPD), and relative attachment level (RAL) were recorded at baseline, 1 month and 3 months in all three groups to compare the clinical efficacy. Results: A statistically significant reduction was observed in PI, sulcus bleeding index, PPD, and RAL at 1 and 3 months in all the three groups. Greater (though statistically nonsignificant) improvements were observed in Groups B and C. Conclusion: Within limitations of the study, it can be concluded that multiple applications of 1% chlorhexidine and thymol varnish (Cervitec Plus) have an added benefit over the single application in the treatment of chronic periodontitis.
Keywords: Chlorhexidine, chronic periodontitis, local anti-infective agents, nonsurgical periodontal debridement, scaling, subgingival
|How to cite this article:|
Sachdeva S, Grover V, Malhotra R, Kapoor A, Mohanty K. Comparison of clinical effectiveness of single and multiple applications of 1% chlorhexidine varnish (Cervitec Plus) along with scaling and root planing in patients with chronic periodontitis. J Indian Soc Periodontol 2018;22:523-8
|How to cite this URL:|
Sachdeva S, Grover V, Malhotra R, Kapoor A, Mohanty K. Comparison of clinical effectiveness of single and multiple applications of 1% chlorhexidine varnish (Cervitec Plus) along with scaling and root planing in patients with chronic periodontitis. J Indian Soc Periodontol [serial online] 2018 [cited 2019 Feb 18];22:523-8. Available from: http://www.jisponline.com/text.asp?2018/22/6/523/244559
| Introduction|| |
Periodontal diseases are the most prevalent immunoinflammatory afflictions of the oral cavity caused by microbial and host interactions, leading to the destruction of attachment apparatus of teeth, eventually leading to tooth loss.,,, Mechanical plaque removal is essential, and the most elementary treatment procedure for the management of periodontal infections, but may not provide optimal benefits in areas of complex anatomy such as deep pockets, developmental grooves, and furcations.,, In the past, the use of antimicrobial therapy to complement the results of mechanical cleaning has been extensively researched and practiced in routine clinical care. Concerns about systemic antimicrobials, such as inability to deliver adequate concentration locally for sufficient period of time, development of resistance strains, associated adverse effects, and drug interactions; and limitations of topical application of solutions either by mouthwash or by irrigation which failed to retain the antibacterial activity at the site for longtime to provide sustained effectiveness, provided the impetus for the development of novel methods of antimicrobial application.,,
Intrapocket administration, i.e., application of an antimicrobial agent at the site of infection, achieves greater concentration of the drug (sometimes 100 folds more than minimal inhibitory concentration), lessens the chance of developing drug resistance, enhances patient compliance, reduces the risk of extraoral superinfections, and avoids gastrointestinal adverse reactions due to minimal systemic uptake.,,,, A number of controlled drug delivery devices have been designed; each vehicle system has its benefits and limitations.,, The fiber used earlier was nonbiodegradable and required removal at the end of the therapeutic period, and its placement was also somewhat difficult in some interdental as well as furcation areas.,, The use of chlorhexidine chips also has carried some concerns regarding their longtime retention and cost-effectiveness., Minor irritation has been observed in few of the cases treated with chlorhexidine chips.
Varnishes are a novel class of vehicles emerging for antimicrobial delivery in the management of oral infections. An ample dosage is administered and retained at the site of action, minimizing the associated adverse effects. The most salient advantage offered by this mode is prolonged direct contact of the drug with the affected tissue. It further allows multiple site intervention, thus enhancing its cost-effectiveness. Hence, varnishes seem quite promising as vehicles for local delivery of antimicrobial agents in periodontal milieu.
Chlorhexidine is without doubt the “gold standard” among the available antiplaque agents., Varnishes containing chlorhexidine are available in the concentrations of 1% (Cervitec), 10% (chlorozoin), 35% (EC 40), and 20% (Bio C).In vitro studies by Petersson et al. have designated potential periodontal pathogens, Porphyromonas gingivalis, and Aggregatibacter actinomycetemcomitans as being the most sensitive bacteria to the chlorhexidine–thymol varnish (Cervitec). Matthijs and Andriaens stated that to accomplish a reservoir of chlorhexidine on the tooth surface, a high concentration can make a reservoir in a single application; however, multiple applications are needed to accomplish the same in case of low-concentration varnishes (Cervitec). Puig Silla et al. also recommended to utilize the increased frequency of applications to retain the antibacterial effect for a longer span of time.
The present study was aimed at comparing the clinical effects of commercially available 1% chlorhexidine–thymol varnish, in single and multiple applications of its subgingival administration for 15 days, in combination with mechanical therapy.
| Materials and Methods|| |
Thirty patients (18 males and 12 females) in the age group of 30–65 years diagnosed with moderate-to-severe chronic periodontitis were selected among the patients visiting the dental outpatient department. The study protocol was approved by the Institutional Ethical Committee (BFUHS/2k10/p-TH/8683). The study purpose, course, and duration were informed to the participants, and their informed consent was obtained. The sample size was determined with a power of 80% based on the previous studies.
The patients diagnosed with moderate-to-severe chronic periodontitis with pocket depth of 5 mm or more around at least one tooth in each quadrant, with no previous history of allergy to chlorhexidine, no history of use of any active-medicated oral hygiene preparation, and willing to participate in the study were included in the study.
The patients diagnosed with any systemic disease/condition or under any long-term systemic medication, wearing orthodontic appliances, or other removable appliances; patients on any antimicrobial drugs in the previous 3 months, having hypersensitivity to chlorhexidine; pregnant/nursing women; patients on any drug/alcohol abuse; sites neighboring recent extraction sockets; and teeth with presence of any periapical/pulpal alterations were excluded from the study.
The patients were categorized randomly into three groups of 10 patients each depending on the frequency of chlorhexidine varnish application. Group A patients received a single subgingival application of Cervitec Plus; Group B patients received two subgingival applications of Cervitec Plus at a week's interval; and Group C patients received three subgingival applications of Cervitec Plus with 7-day interval in between two applications.
The clinical measurements recorded for all patients in the study were as follows: plaque index (PI), Sulcus Bleeding index (SBI) (Muhlemann and Son in 1971), probing pocket depth (PPD), and relative attachment level (RAL). A UNC 15 calibrated periodontal probe and a customized acrylic stent were used for recording parameters.
One percentage of chlorhexidine varnish (1% chlorhexidine varnish commercially available as Cervitec Plus (Ivoclar Vivadent, Schaan, Liechtenstein), which consists of 1% chlorhexidine diacetate and 1% thymol as active antimicrobial ingredients. The base solution used for active agents is ethanol/water. Polyvinyl butyral is present as a polymer vehicle.
[Figure 1] depicts a flowchart describing the study method.
|Figure 1: Flowchart showing chronological order of procedures done during the study|
Click here to view
After patient selection, clinical parameters, i.e., PI, sulcular bleeding index (SBI), PPD, and RAL were recorded for selected teeth. Phase 1 therapy was performed in two sessions within a time frame of 24 h. After complete scaling and root planing (SRP), the varnish was applied subgingivally into the experimental sites. The experimental sites were isolated with cotton rolls and dried with compressed air. A 30G insulin syringe was used for varnish application. Tip of the needle was introduced atraumatically into the pocket depth without touching the base of the pocket. Varnish was then expressed into the pocket until the pocket was completely filled. Subgingival varnish application was done circumferentially along the entire tooth surface and was left to dry for 15–30 s.
The patients were asked to avoid eating, drinking, and rinsing after application, at least for 30 min, resume normal oral hygiene procedures next morning, not to use any chemotherapeutic mouthrinse or oral irrigation devices during the course of study and to report in case of sensitivity, swelling, local pain, or any other adverse reaction at the site of application if any.
A second application of varnish was carried out in Group B patients after 7 days. The third and last applications of varnish were carried out in Group C patients after 14 days from baseline.
Two recall appointments were scheduled, i.e., 1 and 3 months from the baseline for all study groups as recommended in the previous literature.,, At both follow-up visits, all clinical parameters were reevaluated; oral hygiene instructions were revised; and any adverse effects, such as extrinsic staining, taste disturbances, mucosal erosion, and tenderness or enlarged gums, were observed by routinely questioning patients about the presence of any symptoms.
The statistical analysis was carried out using Statistical Package for Social Sciences version 15.0 (SPSS Inc., Chicago, IL, USA). The mean and standard deviation for all parameters were calculated. The statistical significance of differences in independent variables for the intragroup measurements was analyzed using Student's t-test (two-tailed, paired). The statistical significance of intergroup differences in measurements was tested using one-way analysis of variance (ANOVA) test, and for multiple comparisons between groups post hoc, the Bonferroni test was used. A two-tailed P < 0.05 was considered as statistically significant. No statistically significant difference was found at baseline between the groups on the basis of age (by using ANOVA) and sex (by using Chi-square test).
| Results|| |
The study population consisted of 19 males (63.3%) and 11 females (36.7%). One patient from Group A failed to attend the second recall examination whose data were excluded from the study. Male:female ratio in Group A, Group B, and Group C was 4:1 (male = 80.0%, female = 20.0%), 7:3 (male = 70.0%, female = 30.0%), and 2:3 (male = 40.0%, female = 60.0%), respectively. The age of participants ranged from 30 to 55 years and the mean age of participants in Groups A, B, and C was 38.80 ± 6.17 years, 37.10 ± 7.62 years, and 37.90 ± 4.95 years, respectively. Intragroup variation of different parameters, namely PI, SBI, PPD, and RAL in three groups at different observation periods is summarized in [Table 1]. A statistically significant reduction in PI, SBI, PPD, and RAL was observed at both 1 and 3 months in all the three groups.
|Table 1: Mean change for plaque index, sulcus bleeding index, probing pocket depth, and relative attachment level at each follow-up in Group A, Group B, and Group C|
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Reduction in mean values of PI, bleeding index, PPD, and RAL in three groups at 1 month and 3 months is represented in [Figure 2], [Figure 3], [Figure 4], [Figure 5], respectively. Intergroup comparisons revealed nonsignificant differences in PI, SBI, PPD, and RAL between three groups at different periods of observation [Table 2].
|Figure 2: Line diagram showing change in plaque index score at different observation periods in Group A, Group B, and Group C|
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|Figure 3: Line diagram showing change in bleeding index at different observation periods in Group A, Group B, and Group C|
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|Figure 4: Line diagram showing change in pocket depth (in mm) at different observation periods in Group A, Group B, and Group C|
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|Figure 5: Line diagram showing change in relative attachment level (in mm) at different observation periods in Group A, Group B, and Group C|
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|Table 2: Comparison of mean change in plaque index, sulcus bleeding index, probing pocket depth, and relative attachment level at each follow-up between Group A, Group B, and Group C|
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| Discussion|| |
The present study was conducted to compare the clinical effects of single and multiple subgingival administrations of 1% chlorhexidine varnish in combination with mechanical therapy for the treatment of chronic periodontitis. The results elucidated a statistically significant reduction in clinical parameters (PPD, RAL, PI, and SBI) in all the three groups at 1 month and 3 months as compared to baseline. Similar findings have been reported by Cosyn et al., in 2005 and 2007, following subgingival administration of 35% chlorhexidine varnish (EC-40) after SRP., The results are also in accordance with the findings of George et al., who observed statistically significant reduction in PI and bleeding index scores after a single application of 1% chlorhexidine varnish at 3 months. Jagadish Pai et al. reported significant improvements in participants using chlorhexidine varnish as well as chip as mode of delivery. Manikandan et al. reported beneficial effects of 1% chlorhexidine in reducing deposition of plaque, lowering scores of gingival index, and bleeding on probing in patients with chronic gingivitis. They also emphasized on multiple applications of varnish after SRP to sustain the clinical improvements for an extended span of time.
Results of the present study are in contrast with the study done by Dudic et al., who reported no change in PI and pocket depth reduction up to 12 weeks in patients receiving supragingival 1% chlorhexidine vanish application after mechanical therapy as compared to patients receiving placebo varnish. They observed a reduction in bleeding score up to 4 weeks after varnish application, but again a significant increase from week 4 to week 12. The authors speculated the exhaustibility of drug reservoir on the surfaces within 4 weeks of time. The differences in findings may be attributed to differences in patient selection and the method of varnish application. Clavero et al. reported a nonsignificant reduction in PI scores of institutionalized elderly patients for 6 months, which they attributed to poor oral hygiene of elderly patients, presence of removable prostheses, and also the outcome may have been influenced by the older age of patients in their study (≥65 years).
Intergroup comparison revealed additional pocket depth reduction and clinical attachment gain in patient groups receiving two and three applications of chlorhexidine varnish as compared to the patients receiving single subgingival application; however, the differences between observations were not statistically significant. There were no significant differences observed among the mean plaque and bleeding index scores between all three groups. This is by far the first investigation comparing the effect of single and multiple subgingival applications of chlorhexidine varnish on clinical parameters measuring periodontal disease. Although the impact of repeated varnish applications on caries incidence has been studied, it failed to provide any conclusive evidence, as different studies provided varied results (Bratthall et al. 1995, Fennis-Ie et al. 1998, Joharji and Adenubi 2001, and Baca et al. 2002, 2004) whereas others refuted a decrease of caries incidence (Jenatschke et al. 2001 and de Soet et al. 2002) with repeated applications of chlorhexidine varnish. Ribeiro et al. have observed that repeated applications of 1% chlorhexidine varnish do not provide any added benefit on biofilm formation and counts of Streptococcus mutans. Ribeiro et al., in 2011, evaluated the effect of different 1% chlorhexidine varnish application protocols on biochemical constitution of plaque in school children but did not observe any difference between the different groups.
It can be interpreted that either multiple applications of varnish do not have added benefit for improvement of clinical parameters or the differences between findings may not have reached statistical significance. However, as Greenstein mentioned that if the differences between different study groups are not statistically significant, it does not denote that the differences are not clinically meaningful with regard to a desired outcome, however, there are hardly many reliable methods to understand the significance of minor changes.
| Conclusion|| |
Limitations of this study include smaller sample size and lack of concomitant microbial and biochemical analysis that could have helped in better interpretation of findings related to multiple applications of varnish. Within the limitations of the study, it can be concluded that multiple applications of 1% chlorhexidine and thymol varnish have an added benefit over single application in the treatment of chronic periodontitis. One percentage of chlorhexidine varnish provides a safe, effective, and easy to apply adjunct to SRP to achieve good clinical results for the management of patients suffering from periodontitis. The future research and longitudinal studies with larger sample size along with concomitant biochemical and microbial analysis are recommended to further ascertain these findings.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
[Table 1], [Table 2]