Dr. Shreya Shetty et al., Asian Journal of Pharmaceutical Technology & Innovation, 01 (03); 2013; 01-08

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1 Asian Journal of Pharmaceutical Technology & Innovation ISSN: Received on: Accepted on: Published on: Corresponding Author: *DR. SHREYA SHETTY* M.D.S. (PERIODONTICS) * Department of Periodontics Bangalore Institute of Dental Sciences & Postgraduate Research, Hosur Road, Bangalore , Karnataka State. Fax no * Id- drshreyak@rediffmail.com Research Article Comparative Efficacy of Chlorhexidine and a Herbal Mouth Rinse in Patients with Gingival Inflammation - A Clinical & Microbiologic Study Dr. Shreya Shetty *, Dr. Surya Pillai, Dr. Srirangarajan Sridharan, Dr. Aparna Satyanarayana, Dr. Aparna Rahul ABSTRACT BACKGROUND: Current trends have witnessed a popular inclination towards the use of herbal products in the field of medicine and dentistry mainly because they are naturally occurring and have fewer side effects. Herbal mouthrinses have been recently introduced with the objective of achieving effective plaque control. Till date, chlorhexidine has been a gold standard with regard to anti-plaque agents. The objective of this randomized double blinded controlled pilot study therefore was to assess and compare for the first time, the clinical and microbiological efficacy of chlorhexidine and a herbal mouthrinse in patients with chronic gingival inflammation. MATERIALS & METHODS:- 40 systemically healthy subjects between the age groups of yrs with chronic gingival inflammation received oral prophylaxis as part of phase 1 therapy after which they were asked to refrain from oral hygiene measures, and then randomly divided into 2 groups of 20 patients each, one prescribed chlorhexidine and the other, herbal mouthrinse( hiora) twice daily for 2 minutes for four days. On day 5, subgingival plaque samples were collected for culture. Clinical periodontal parameters viz plaque index, gingival index and oral hygiene index were assessed on day 0 and day 5 and analyzed statistically RESULTS There were no statistically significant differences between the two groups with regard to the clinical parameters and colony counts of the bacteria. However, the chlorhexidine group showed statistically suggestive significance with respect to inhibition of S. mutans(p<0.1) and moderate significance with respect to inhibition of A.comitans.(p<0.05) CONCLUSION Herbal mouth rinses may be as effective as chlorhexidine as chemical anti-plaque agents with fewer side effects. However, alternative study designs using larger sample sizes and longer duration are needed to further reiterate its benefits. Key-words: Mouthrinses, chlorhexidine, herbal mouthrinse, bacterial culture. Cite this article as: Dr. Shreya Shetty, Dr. Surya Pillai, Dr. Srirangarajan Sridharan, Dr. Aparna Satyanarayana, Dr. Aparna Rahul, Comparative Efficacy of Chlorhexidine and a Herbal Mouth Rinse in Patients with Gingival Inflammation - A Clinical & Microbiologic Study, Asian Journal of Pharmaceutical Technology & Innovation, 01 (03);

2 INTRODUCTION: Mouthwashes (mouthrinses) are solutions or liquids used to rinse the mouth for a number of purposes: (a) to remove or destroy bacteria (b) to act as an astringent (c) to deodorise and (d) to have a therapeutic effect by relieving infection or preventing dental caries 1. They come under the broad blanket of chemical plaque control agents.commercially available artificial drugs have unpleasant side effects and moreoever, the number of drug resistant microorganisms is increasing. Chlorhexidine(CHX) is considered the most common and extensively studied chemical agent for plaque control to date 1. It has been used as an adjunct to mechanical plaque control such as tooth brushing and oral prophylaxis for the maintenance of proper oral hygiene. Inspite of potent antimicrobial and anti plaque properties of chlorhexidine, its widespread and prolonged use is limited by its local side effects. The adverse effects of chlorhexidine include extrinsic staining of teeth 2, transient impairment of taste sensation and taste perturbation 3. Occasionally reported are cases of burning sensation and painful desquamation of the oral mucosa. The search for alternative products has led to the evolution of natural phytochemicals isolated from plants which have been used in traditional medicine and are considered as good alternatives to synthetic chemicals. Medicinal plants have been used as traditional treatments for numerous human diseases for thousands of years and in many parts of the world. In rural areas of the developing countries, they continue to be used as the primary source of medicine 4. About 80% of the people in developing countries use traditional medicines for their health care. The natural products derived from medicinal plants have proven to be an abundant source of biologically active compounds, many of which have been the basis for the development of new lead chemicals for pharmaceuticals 5. Ayurveda is an ancient Indian science that mainly involves the use of naturally occurring herbs and shrubs to provide a cure for medical ailments without causing any undue side effects. Ayurveda is popular in Asia and Europe and in the opinion of the authors, is fast gaining recognition worldwide. Many plant-derived medicines used in traditional medicinal systems have been recorded in pharmacopeias as agents used to treat infections and a number of these have been recently investigated for their efficacy against oral microbial pathogens 6. Natural herbs like neem, tulsi, triphala,clove oil, ajwain, etc. have been used alone or in combination and have been scientifically proven to be safe and effective medicine against various oral health problems like bleeding gums, halitosis,mouth ulcers and decay. The major strength of these natural herbs is that their use has not been reported with any side effect till date 7. One such herbal product is Hiora**, a herbal mouthwash known for its antiseptic, antimicrobial, antiplaque and analgesic property 8. Hiora contains herbs having antimicrobial properties such as oil of syzygium aromaticum, cinnamomum zeylanicum, and extract of spinacia oleracea, triphala, trikatu and powders of yashada bhasma and suryakshara. syzygium aromaticum which have shown to have antifungal, antiviral, analgesic/anesthetic,antiseptic, anticoagulant and antioxidant properties. Oil of clove has also shown antimicrobial activity

3 AIMS & OBJECTIVES The objective of this double blinded randomized controlled pilot study was to comparatively assess and evaluate whether the clinical and antimicrobial effects of the herbal mouthrinse( hiora) was as effective as chlorhexidine as a chemical anti-plaque agent. MATERIALS & METHODS Following the approval of the Ethical Committee of Bangalore Institute of Dental Sciences, Forty systemically healthy subjects aged yrs were recruited for this double blinded randomized controlled experimental pilot study from the Institute in the period between January 2011 and March 2011 based on the following criteria: 1. Presence of mild to moderate chronic gingival inflammation. 2. Absence of periodontal pockets. 3. Negative history of smoking or tobacco/paan/betelnut chewing. 4. Subjects carrying out optimal plaque control and oral hygiene measures. 5. Subjects not using mouthwash or any other chemical anti-plaque agent as adjunctive oral hygiene methods. 6. Subjects who have not had any infection, systemic or oral, in the last 6 months and have not taken any drugs during the same period. The selected subjects were required to sign a consent form confirming their agreement to participate in the study. ** Himalaya drug company, Bangalore, India. At baseline, oral prophylaxis was done for all the 40 subjects and they were in turn asked to refrain from any oral hygiene measures. They were then randomly assigned to two groups, test and control. The test Group was prescribed the herbal mouthrinse( Hiora) and the control group was prescribed Chlorhexidine(Peridex), Both the mouthrinses were packed in similar coloured bottles but labeled/coded differently and randomly administered to the subjects by a blinded operator. The operator merely made note of the code administered against the subjects name. The subjects were also unaware of which mouthrinse they were being administered. They were asked to rinse with 5ml of mouthrinse for 2 min twice daily for 4 days. On the 5 th day, the subgingival plaque samples were collected from all the patients in both the groups and sent for microbiological analysis by culture. Clinical periodontal parameters such as plaque index, gingival index, oral hygiene index and bleeding index were also assessed on the 5th day. The selected subjects also filled up a questionnaire regarding the comfort and the pleasantness of the mouthrinses prescribed at the end of the 5th day. The clinical parameters and colony counts of the microorganisms obtained by culture were analyzed statistically by descriptive statistical analysis. The Statistical software namely SAS 9.2, SPSS 15.0, Stata 10.1, MedCalc were used for the analysis of this data. RESULTS Comparison of Clinical Variables (TABLE 1)(FIGURE 1,2,3&4) 3

4 There were no statistically significant changes between the 2 groups when the clinical parameters viz, plaque index, gingival index, oral hygiene index and bleeding index were compared at the end of 5 days.(p >0.5). TABLE-1 COMPARISON OF CLINICAL VARIABLES Comparison of Bacterial Culture (TABLE 2 &3)(FIGURE 5) The Periodontal pathogens observed with the culture of plaque samples were Porphyromonas gingivalis (Pg), Actinobacillus actinomycetemcomitans(aa) and the cariogenic pathogens such as Streptococcus mutans and Escheria coli. There was statistically significant reduction of Aa in the chlorhexidine group compared with the herbal group (p >0.01). On the contrary, there was suggestively significant reduction of streptococcus mutans in the herbal Dr. Reddy s laboratories, Hyderabad, India. group compared to the chlorhexidine group.( 0.05<P<0.10) TABLE 2: COMPARISON OF BACTERIAL CULTURE + Suggestive significance (P value: 0.05<P<0.10) * Moderately significant ( P value:0.01<p 0.05) ** Strongly significant (P value : P 0.01) 4

5 TABLE 3: COMPARISON OF BACTERIAL COLONY COUNT DISCUSSION As dental plaque is a well known etiologic factor for gingivitis, optimal plaque control is essential to prevent and/or arrest the uncomplicated gingival inflammation 15. Mechanical measures such as tooth brushing and other home devices are the most commonly used methods to clean the teeth. However it has been revealed that the vast majority of patients will not always completely remove all the plaque by these ways 16. Furthermore for handicapped or elder individuals use of mechanical methods is more problematic due to their compromised dexterity or motivation 17. To overcome those shortcomings chemical plaque control has been a subject of scientific interest. Antimicrobial rinses have been considered safe in reducing plaque and gingivitis 18. Chlorhexidine(CHX) is the most common and extensively studied chemical agent for plaque control to date 1. Its efficacy as a mouthrinse 19 and as a local drug delivery agent 20 to inhibit dental plaque and gingivitis has been well documented. It is considered the gold standard of chemical anti-plaque agents against which the efficacy of other antimicrobial and antiplaque agents is assessed 21 mainly because of its broad spectrum of activity against most of the oral pathogens. Inspite of potent antimicrobial and anti plaque properties of chlorhexidine, its widespread and prolonged use is limited by its local side effects. The adverse effects of chlorhexidine include extrinsic staining of teeth 2 ) transient impairment of taste sensation and taste perturbation 3. Occasionally reported are cases of burning sensation and painful desquamation on oral mucosa.in view of this, herbal products are steadily gaining interest in the present era as they are naturally occurring, hence economical. They also claim to have little or no side effects 22. Herbal (HiOra) mouthrinse has shown antibacterial and anti-inflammatory effect in a few studies 23. The present study was therefore carried out to evaluate whether the clinical and antimicrobial efficacy of herbal(hiora) mouthrinse was as good as or better than chlorhexidine mouthrinse. As scaling and root planning was done at baseline, all periodontal indices were essentially zero at baseline. Evaluation of the clinical parameters at the end of 5 days showed no significant differences between the 2 groups. This definitely suggests that the clinical efficacy of the 2 methods is nearly the same which is in accordance with a study carried out on similar lines 8. Chlorhexidine has been shown to improve the clinical signs of inflammation when used as an adjunct to scaling and root planning 24, so also herbal mouthrinses have shown effective clinical benefits 25. Since the clinical parameters were not sufficient to establish any difference in the efficacy of the agents, it was decided to correspondingly evaluate their effects on the plaque microorganisms. The 5 day plaque sample is diverse with a combination of periodontal as well as cariogenic pathogens. Since it was a pilot project, it was decided to 5

6 evaluate 2 periodontal pathogens- Aa and Pg and 2 cariogenic organisms Streptococcus mutans and E. coli. The chlorhexidine group showed significant reduction in Aa, in accordance with various studies which have shown effective reduction of actinomyces species by chlorhexidine 26,27. However, there was suggestive significance that the herbal mouthrinse may reduce cariogenic pathogen Steptococcus mutans which is in accordance with studies concluding the same 28. Based on the limited evidence available till date, the herbal mouthrinses have shown antimicrobial efficacy against periodontal and cariogenic pathogens both in vivo and in vitro 22,26,29. The present study also showed findings similar to that observed in the above studies. The clinical and microbiologic effects of both the mouthrinses being comparable, leaves only one area where the comparison between the two could be possibly relevant. It has been reported that long term use of chlorhexidine is limited by staining of teeth and taste alteration 2. However; no such effect has been reported with herbal extracts. In addition, among the various side effects of chlorhexidine, only unpleasant taste was assessed in this study whereas other effects such as staining which is a long term phenomenon, could not be assessed due to short duration of the study. Chlorhexidine s superior anti-plaque effect has been mainly attributed to its unique property of substantivity. The proposed mechanism of HiOra is due to its synergistic action of its potent herbs by virtue of their components which individually exert their antimicrobial activities. Whether substantivity exists or not could not be ascertained in this study. This aspect can spur future research. This being a pilot project, a few limitations were obvious such as short duration, small sample size and limited microbial assessment. Further research needs to focus mainly on these areas and on substantivity of herbal mouthrinses. CONCLUSION Evidence in dental literature support and recognize chlorhexidine as gold standard against which other antiplaque agents are measured. But the long term use of chlorhexidine is limited by its side effects. Herbal products, though negate these effects and can be used safely for a longer time period, still need to establish the property of substantivity in order to reach the gold standard of chlorhexidine. Thus it could be safely concluded that herbal mouthrinses can be used as adjuncts in periodontal therapy, however further long term research on a larger population is recommended. ACKNOWLEDGEMENTS: The authors wish to thank m/s Himalaya Drug Company, Bangalore, India for funding this project. The authors would also like to acknowledge the kind services of Dr. Prahlad Patki, head of research and development, and Dr. Sandeep Varma, Chief research scientist, Himalaya Drug Company, for their valuable assistance in carrying out this study. CLINICAL RELEVANCE: The herbal mouthrinse is suggested as a suitable, economical,safe and viable option to chlorhexidine, as it has similar clinical and antimicrobial efficacy with absolutely no side effects as evidenced with chlorhexidine. 6

7 FIGURE 1: COMPARISON OF GINGIVAL INDEX SCORES IN THE 2 GROUPS FIGURE 2: COMPARISON OF PLAQUE INDEX IN THE 2 GROUPS FIGURE 3 : COMPARISON OF ORAL HYGIENE INDEX SCORES IN THE 2 GROUPS FIGURE 4: COMPARISON OF GINGIVAL BLEEDING SCORES IN THE 2 GROUPS FIGURE 5 :: COMPARISONS OF THE ANTIMICROBIAL EFFICACY OF THE 2 AGENTS SOURCE OF FUNDING: - HIMALAYA DRUG COMPANY, BANGALORE 7

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