Comparative Evaluation of Clinical Efficacy of Chlorhexidine, Phenolic and Chitosan Mouthrinses on Plaque and Gingivitis: Single-Centre, Double Blind, Randomized Controlled Clinical Study

Research Article

Austin J Dent. 2017; 4(1): 1064.

Comparative Evaluation of Clinical Efficacy of Chlorhexidine, Phenolic and Chitosan Mouthrinses on Plaque and Gingivitis: Single-Centre, Double Blind, Randomized Controlled Clinical Study

Shah HP*, Bhavsar NV and Chavda MG

Department of Periodontia, Gujarat University, India

*Corresponding author: Shah HP, Department of Periodontia, Government dental college and hospital, Gujarat University, A/94, Natasha Park-2, Opp. Military boys hostel, Chhani road, Vadodara- 390002, Gujarat, India

Received: December 04, 2016; Accepted: January 20, 2017; Published: January 23, 2017

Abstract

The present study was conducted to determine the effect of different mouthwash preparations used as supplement to regular oral hygiene measures on plaque and gingivitis.

A total of 40 patients with chronic gingivitis demonstrating good oral hygiene were recruited for the study and divided into 4 groups. The subjects were briefed about the nature of the study and informed consents were taken. 4 different mouthwash preparations were given among the 4 groups. They are chlorhexidine digluconate, phenolic (Essential oil), chitosan anti-adhesive mouthwash and placebo (distilled water) for the control group. Clinical parameters including gingival index (Loe-Silness, 1963), plaque index (Turesky modification of Quigley-Hein, 1970) and stain index (Lobene, 1968) were recorded at baseline, 3 weeks and 6 weeks for all 4 groups.

Results showed that there is highly statistically significant decrease in plaque and gingival index in chlorhexidine and Essential oil group, statistically significant decrease in chitosan and placebo group. Findings from this study indicate chlorhexidine to be the most effective anti-plaque and anti-gingivitis agent, followed by Essential oil mouthwash with the benefit of reduced staining, thus can be used on long term basis, and whereas chitosan is not significantly effective compared to placebo group.

Keywords: Chlorhexidine; Phenolic; Chitosan; Mouthwash; Plaque; Gingivitis

Abbreviations

CHX: ChlorHeXidine; Ch: CHitosan; EO: Essential Oil

Introduction

The most common prevalent infectious oral diseases in humans are caries and periodontal diseases, including gingivitis and periodontitis, which are usually associated with dental plaque [1]. Removal of this bacterial biofilm is a decisive factor in the prevention as well as treatment of these diseases.

This specific form of biofilm can be negatively affected by plaque control. Plaque control includes the mechanical as well as chemical approaches to retard the plaque formation. Mechanical approaches include tooth brushing, interdental cleaning, using oral hygiene aids and professional prophylaxis. The effectiveness of this method mainly depends on the individual’s manual ability and motivation. However, the efficacy of mechanical debridement is limited by deep periodontal pockets, concavities, grooves and furcations in which pathogens persist. Moreover, recolonization of debrided sites by pathogenic bacteria from other intraoral niches has been reported [2]. This fact, couples with an increase in the information available on the microbiology of periodontal disease has stimulated a great interest in developing topical antimicrobial agents to control biofilm [3,4].

Over the years, a number of enzyme preparations, antiseptics (e.g., bisbiguanides, quaternary ammonium compounds, phenolic compounds, alkaloids, fluorides) and surface active agents have been developed and tested. [5,6].

Among the chemotherapeutic agents used in mouth-washes, chlorhexidine based formulations are currently the gold standard [7], with abundant evidence supporting its effectiveness. In spite of this proven effectiveness its long term use is limited because of some distinct adverse side effects like brownish staining of teeth, mucosal erosions [8].

Phenols and essential oils have been used in mouthrinses and lozenges for many years, which act via both a plaque inhibitory action and an anti-inflammatory action, possibly due to an anti-oxidative activity [9].

Chitosan, only natural polysaccharide that presents cationic character due to its amino groups which, at low pH, are protonated and can interact with negatively charged compounds such as proteins, anionic polysaccharides (e.g. alginates, carragenates, pectins), fatty acids, bile acids and phospholipids [10]. This behavior, along with its biocompatibility, biodegradability and lack of toxicity, has led to the usage of chitosan in diverse fields as technology, food, cosmetics, medicine, biotechnology, agriculture and the paper industry [11,12].

In recent years, a great attention has been devoted to the use of chitosan for pharmacological and biomedical applications. It exhibits various promising biological activities such as antimicrobial, antifungal, biodegradable, bio adhesive and biocompatible properties. It has shown excellent in vitro effect on bacterial biofilm as mouthrinse. So, naturally desirable next step would be testing in vivo clinical effectiveness. It is produced commercially by de acetylation of chitin, which is the structural element in the exoskeleton of crustaceans (crabs, shrimp, etc.) and cell walls of fungi [13].

Therefore, this study was undertaken with the purpose of exploring the potential of chitosan as a mouthrinse and comparing it with that of the established agents such as the ‘gold standard’ chlorhexidine and Essential oil mouthrinses on plaque and gingivitis.

Material and Methods

A group of 40 patients, 21 males and 19 females, in the age group of 16 to 50 years, from outpatient department at Department of Periodontia, Government dental college & hospital, Ahmedabad were recruited in the study.

Inclusion criteria

The patients with history of any systemic disorder, drug therapy, and parafunctional habits were excluded as they may alter the treatment plan or affect the outcome of the treatment. The patients with habits of tobacco chewing, smoking, or snuffing were excluded because of their established role in altering the soft tissue response, which may affect evaluation of clinical effect of mouthrinses on gingival health. Also, the stains produced by them, mask the true clinical effects of mouthwash on teeth staining.

Study protocol

At baseline, a complete intraoral soft tissue & hard tissue examination was performed and clinical parameters were recorded, including Plaque index (Turesky modification of Quigley & Hein index 1970) [14,15], gingival index (Loe & Silness 1963) [16] and Stain index (Modification of Lobene index 1968) [17] by the examiner in all the patients. They were rendered scaling and polishing along with root planing. They were instructed to continue to exercise their regular non-supervised, self-performed plaque control.

Patients were now divided into 4 groups. Group A (chlorhexidine), Group B (Essential oil), Group C (chitosan) and Group D (Placebocontrol). To avoid bias, this random division and allocation of respective mouthrinses were done by a junior resident student of the Periodontia department by withdrawing chit from box method. Resident was unaware of the study findings recorded by the examiner. Also, different mouthrinses were allocated in similar opaque white colored bottles for subject blinding. The members of control group and Essential oil group rinse vigorously with 20 ml for 30 s twice daily for 6 weeks. While chlorhexidine group and chitosan group rinse with 10 ml for 60 s twice daily for 6 weeks. At 3 weeks and 6 weeks after baseline, parameters were recorded again.

Materials used-Chlorhexidine mouthwash

Commercially available 0.2% chlorhexidine gluconate mouthwash. (Eludril perio, mouthwash, WIN Medicare pvt. Ltd, New Delhi, India)

Essential oil mouthwash

Commercially available Essential oil anticavity fluoride mouthwash (Listerine, Pfizer Consumer Healthcare, Morris Plains, New Jersey, USA)

Chitosan polymeric anti-adhesive mouthwash

Chitosan mouthwash formulation (Ch) was prepared using High Molecular Weight (DD >75%; MW 624 kDa) and Low Molecular Weight chitosan (75% < DD < 85%; MW 107 kDa) with the final concentration of either chitosan being 0.4% (v/v). The chitosan based mouthwash, prepared for a final pH of 5,contained 0.5% (w/v) salt (NaCl), 1% (w/v) stabilizer (arabic gum), 5% (w/v) sweetener (mannitol). Food grade flavoring and coloring were gently provided added at 0.1% (v/v) each.

(School of pharmacy, R.K University, Rajkot, Gujarat)

Placebo group

Distilled water.

Results and Statistical Analysis

The data obtained from the present study was suitably tabulated in appropriate tables. The mean and

Standard deviation was calculated for various parameters. The changes in clinical parameters from baseline, 3 weeks and 6 weeks were analysed among all the 4 groups using ANOVA test and adjusted p -values by performing bonferroni post-hoc test.

P-Value <0.05 is significant

P-Value <0.001 is highly significant

The result of the present study permitted following conclusions to be drawn:

There is highly statistically significant (p< 0.001) decrease in plaque index in chlorhexidine and essential oil mouthrinse groups (Table 1, Figure 1 and 2). There is highly statistically significant (p< 0.001) decrease in gingival index in chlorhexidine and essential oil mouthrinse groups (Table 2, Figure 1 and 2).