Evaluation of efficacy of clorni* gel as an adjunct to phase 1 Therapy, in the treatment of gingivitis - A randomisedControlled clinical study.

Introduction

Periodontitis is preceded by gingivitis & to prevent its progression to periodontitis, successful periodontal therapy is required; which can be achieved by effective scaling & root planning & also by adjunctive use of anti-microbial agents.^1,2 These agents can be used for rinsing, irrigation, systemic administration or local application. A 100- fold higher concentration of antimicrobial agents can be achieved by local route of drug delivery as compared to systemic administration.⁹ Various chemotherapeutic agents including tetracycline, doxycycline, metronidazole, ornidazole and chlorhexidine are available for local application. Ornidazole, is efficient strictly against anaerobic bacteria and has antibacterial activity, due to reduction of the nitro group to a more reactive amine that attacks microbial DNA inhibiting further synthesis and causing degradation of DNA.³ Chlorhexidine is considered as gold standard for the treatment of gingivitis. Not much research has been done to study the efficacy of ornidazole as topical application for the treatment of gingivitis. Hence, the need for the study is to compare the efficacy of 1% Ornidazole and 0.25% Chlorhexidine gluconate (Clorni*) and 1.0% Chlorhexidine gluconate (Hexigel*) in the treatment of gingivitis.

Materials and Methods

In this clinical study, a sample of 30 subjects in the age group of fifteen years to thirty years were selected and the study was carried out for one year. The sampling method used was convenience sampling. The study was approved by the Institutional Review Board.

Inclusion Criteria:

a) Age group: 15-30 years,

b) Plaque score ≥1

c) Bleeding on brushing,

d) Probing depths lesser than 5mm,

e) Presence of gingival inflammation,

f) Absence of bone loss.

Exclusion Criteria:

a) Patient having any systemic disease,

b) Patient allergic to nitro -imidazole group of drugs,

c) Patients under orthodontic treatment,

d) Those having radiographic evidence of bone loss,

e) Those who had a habit of smoking or using tobacco in other forms,

f) Previous history of periodontal therapy,

g) Previous use of antibiotics or anti-inflammatory medication within the preceding six weeks,

e) Pregnant females.

Treatment protocol8

Each patient was given a detailed verbal description of the study and all the selected patients were required to sign an informed consent prior to commencement of the study.

Patients were selected, based on the inclusion and exclusion criteria. At first session case history was recorded, clinical parameters were determined by recording Gingival Index (Loe&Silness, 1963), Plaque Index (Silness& Loe,1964), Papillary Bleeding Index (Muhlemann,1977).

Patients were randomly assigned to two groups. In group one (control group), patients underwent scaling and root planing, and hexigel* application. In group two (test group), patients underwent scaling and root planing, and clorni* gel application, followed by baseline recordings in both the group.

Patients were instructed to apply one half inch of the ointment to the finger and smear this buccally and lingually over each quadrant of the mouth.

Demonstration of the application method was given to each patient. Five minutes after application, patients were instructed to rinse their mouth. Patients were instructed to use the gel twice daily, morning and before bedtime & were asked to avoid any usage of mouth wash during the study period.

Patients clinical parameters were assessed at baseline, seventh day and at one month. Oral hygiene maintenance was reinforced at every visit.

Statistical analysis

Statistical Package for Social Sciences [SPSS] for Windows, Version 22.0. Released in 2013. Armonk, NY: IBM Corp., was used to perform statistical analyses.

Descriptive Statistics:

Descriptive analysis includes expression of all explanatory and outcome variables in terms of Mean and SD for continuous variables, whereas in terms of frequency and proportions for categorical variables.

Inferential Statistics:

Age wise and gender wise distribution of demographic characteristics among the participants were analysed by Mann Whitney test and Chi Square test respectively.

Comparison of mean PI Scores, GI scores, and Bleeding Index scores between experimental and control group at different time intervals were analysed using Student Independent t Test.

Comparison of mean PI scores, GI scores and Bleeding Index scores between different time intervals in each group were analysed using Repeated Measures of ANOVA followed by Bonferroni's Post hoc Test.

The level of significance [P-Value] was set at P<0.05.

Results

The demographic characteristics of the patient sample are summarised in Table 1. There were no significant differences in regards to Age and gender.

Plaque index (PI)

There was an overall statistically significant reduction in the plaque score (p value < 0.001) in both the control and test groups with mean difference of 1.25±0.05 at baseline, 1.04±0.07 at 1 week and 1.03±0.07 at 1 month in Group 1. The mean difference was 1.25±0.05 at baseline, 1.06±0.08 at 1 week and 1.04±0.08 at 1 month in Group 2. Intragroup comparison revealed that PI scores were statistical significant from baseline to one week and from baseline to one month (p value <0.001), but no statistical significance was seen from one week to one month. (Table 2)

On comparison between the groups, plaque index scores were not statistically significant, as the p value was 0.49 at 1 week and 0.64 at 1 month. (Table 3)

Gingival index (GI)

There was an overall statistically significant reduction in the gingival score (p value < 0.001) in both the groups with mean difference of 0.58±0.16 at baseline, 0.13±0.05 at 1 week and 0.13±0.05 at 1 month in Group 1. With respect to Group 2, the mean difference was 0.59±0.14 at baseline, 0.14±0.05 at 1 week and 0.13±0.05 at 1 month. GI scores showed statistical significance from baseline to one week and from baseline to one month (p value <0.001), but no statistical significance was seen from one week to one month, when intragroup comparison was done. (Table 4)

On inter-group comparison, the gingival index score was not statistically significant, since the p value was 0.72 at 1 week and 0.70 at 1 month. (Table 5)

Bleeding Index (BI)

There was an overall statistically significant reduction in the bleeding score (p value ≤ 0.001) in both the groups with mean difference of 0.51±0.37 at baseline, 0.13±0.05 at 1 week and 0.10±0.04 at 1 month in Group 1. With respect to Group 2, the mean difference was 0.59±0.38 at baseline, 0.14±0.05 at 1 week and 0.11±0.03 at 1 month. Intragroup comparison showed that, GI scores were statistical significant from baseline to one week and from baseline to one month (p value ≤0.001), but no statistical significance was seen from one week to one month. (Table 6)

Intergroup comparison revealed that the bleeding index score was not statistically significant with p value of 0.72 at 1 week and 0.58 at 1 month. (Table 7)

Discussion

Periodontal diseases and gingivitis are both biofilm-related diseases; however, while gingivitis is a reversible disease, and therefore could be successfully treated by means of control of supragingival biofilm by mechanical plaque control.⁴ Successful outcome of periodontal therapy depends upon the mechanical debridement, eliminating plaque retentive factors, endotoxin deposits which leads to recolonization of the pathogenic microbes.

Mechanical therapy alone may be unable to completely eliminate periodontal pathogens from the soft tissues and hard tissue surfaces and within other niches in the oral cavity which may cause recolonization of these pathogens leading to reinfection.^5,6 To overcome these deficiencies in traditional periodontal therapy, adjunctive use of chemotherapeutic agents either systemically, locally or topically becomes an indispensable treatment modality.^6,7,8

Since use of systemic antibiotics is associated with some disadvantages such as inability of systemic drugs to achieve high gingival crevicular fluid concentration,⁹ an increased risk of adverse drug reactions,¹⁰ increased selection of multiple antibiotic‑resistant micro‑organisms¹¹ and uncertain patient compliance¹², the local administration of drugs is recommended.

Ornidazole specifically acts on gram negative anaerobic, facultative bacteria which are responsible for periodontal disease. Ornidazole requires a very low minimum inhibitory concentration to inhibit the growth of periodontal pathogens¹³ as compared to that of Metronidazole (Metrogel 1% Marketed formulation). Ornidazole is effective with SRP in reduction of gingival inflammation.¹⁴

Chlorhexidine remains the most effective topical antiseptic reported to date & has been combined with other topical antimicrobial agents to treat gingivitis.¹⁵ In the present study, combination of ornidazole and chlorhexidine in gel form has been used on gingivitis patients, to evaluate its efficacy as an adjunct to phase 1 therapy.

The present study showed a reduction in PI values from baseline to follow up visit in both group 1 and group 2. This can be attributed to the fact that there was a reduction in supragingival plaque after SRP and maintenance of oral hygiene measures. The results of this study were in accordance with Sato K. Yoneyama et al16, who concluded that the high quality self-performed plaque control was maintained during the 5th year of monitoring. Cugini et al¹⁷, reported significant reduction in plaque scores, post 12 months with effective SRP, maintenance and oral hygiene measures. The study done by Bhavin patel et al¹⁸, significant reduction in plaque index score at the end of 4 weeks, which depicts the effect of SRP and patients’ oral hygiene maintenance.

There was reduction in GI scores in both the groups. This may be due to elimination of local etiological factors like plaque and calculus after SRP. This was in accordance with the study done by Hinrichs et al.19 and Cugini et al¹⁷, which showed statistically significant reduction in GI score, following SRP.

There was reduction in BI scores in both the groups. This was in accordance with the study done by Adinarayan R et al.⁸ wherein, bleeding index scores were reduced in both the groups at the end of 1 month.

No significant difference was seen in the clinical parameters between 1 week and 1 month, attributing to the scaling and root planning and oral hygiene maintenance of the patients.8

In the present study, both the groups had similar effects on clinical parameters, which is not in accordance with the study done by Adinarayan R et al.⁸ and M.Nagasreeet al.¹⁴ where the group which was treated with Ornidazole, as an adjunct to SRP had shown better efficacy in terms of all clinical parameters, although their control group had received only SRP. The combination of ornidazole and chlorhexidine, reported no adverse effects and was well tolerated by the patient. Its small sample size and a short term clinical trial, were the limitations of the study.

Conclusion

The clinical trial on clorni gel as an adjunct to phase 1 therapy has shown improved results on the clinical parameters of plaque index, gingival index and bleeding index on gingivitis patients on a short-term basis. Clorni gel can be used as an adjunct to SRP in the treatment of gingivitis.