Effectiveness of a herbal mouthrinse on de novo plaque formation

Background: 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. Objectives: To compare the effeciveness of the herbal mouthrinse (Hiora) against chlorhexidine mouthrinse. Methods:The study is a randomized, double blind, crossover clinical study. At the baseline, the volunteers brush their teeth using toothpaste without any active ingredient for 2 minutes. Oral prophylaxis was performed to ensure that the teeth are free of plaque, stains and calculus. Each subject was randomly assigned to both the experimental groups. During the trials, the volunteers were rinsed their mouths, according to the assigned random sequence of treatments: Chlorhexidine as chemical and HiOra as herbal mouthrinse. Both the mouthrinses were packed in similar coloured bottles but labeled differently and randomly administered to the subjects by a blinded operator. Each subject received oral and written instructions on the use of mouth rinses. After one week, the study subjects were asked to suspend their oral hygiene for 24 hours, and accumulated plaque was re-evaluated with erythrosine. The plaque index was recorded in the six selected teeth at the end of the trial. After the trial period, the usual oral hygiene habits resumed. Results: There were no statistically significant differences between herbal and chemical mouthrinses. Conclusion: Herbal mouth rinses may be as effective as chlorhexidine as chemical anti-plaque agents with fewer side effects.


Introduction
History of medicine is a fascinating subject as it is a saga of man's struggle against disease. As the civilization advances and as the pattern of disease changes, the medical science also changes (Narayanaswami V 1981 p.1). Sprouted in the pristine land of India, some 5000 years ago, Ayurveda, the science of life and longevity, is the oldest healthcare system in the world and it combines the profound thoughts of medicine and philosophy. Since then Ayurveda has stood for the wholesome physical, mental and spiritual growth of humanity around the world. Today, it's a unique, indispensable branch of medicine, a complete naturalistic system that depends on the diagnosis of human body to achieve the right balance. Dental plaque is a biofilm that forms naturally on the surfaces of exposed teeth (Marsh PD et al 1995 p.169). It is a complex organized microbial community which has been the primary etiological factor for the most frequently occurring oral diseases, such as dental caries and periodontal diseases. Although the dental biofilm cannot be eliminated, it can be controlled with comprehensive mechanical and oral hygiene practices. Routine tooth brushing is widely recognized as the first step to mitigate the effects of dental plaque and maintain oral health (Axelsson P 1993 p.219). Several products for chemical inhibition of microbial plaque are available in the dental market. However, certain patients may not be willing or able to perform adequate mechanical plaque removal on a regular basis. These patients could benefit from chemotherapeutic anti-plaque agents as adjuncts to mechanical removal. Topical antimicrobials in dental products have four general mechanisms of action. They can decrease the rate of new plaque accumulation, decrease or remove existing plaque, suppress the growth of pathogenic microflora or inhibit the production of virulence factors (Marsh PD 1992p.1431).Compounds derived from bisbiguanide including chlorhexidinedigluconate (CHX) and alexidina are the most effective agents currently used (Baker PJ et al 1987p.1099).Today, therapeutic ingredients available in mouthrinses include various metal ions such as stannous, zinc, copper and also essential oil mixtures, chlorhexidine (CHX) and cetylpyridinium chloride (CPC) ( .However, these rinses have side effects, such as enamel discoloration, mucosal erosion, taste disturbance, mouth burning, dry mouth, carcinogenic effects and the smoothing of composite materials, which limits their usage to approximately 5 weeks (Moran J et al 1994 p.904). To prevent these side effects, alcohol-free CHX mouth rinses have been developed, one of them is Ondro-hexidine® (One Drop Only GmbH, Stieffring, 14, 13627 Berlin-Germany), which is an alcohol free mouthrinse. 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 (H. R. Chitme et al 2003 p.70). Hiora*, A herbal mouthwash known for its antiseptic, antimicrobial, antiplaque and analgesic property (Narayan A 2012 et al p.460). Hiora contains herbs having antimicrobial properties such as oil of syzygiumaromaticum, cinnamomumzeylanicum, and extract of spinaciaoleracea, triphala, trikatu and powders of yashadabhasma and suryakshara. Syzygiumaromaticum which has shown to have antifungal, antiviral, analgesic/anaesthetic, antiseptic, anticoagulant and antioxidant properties. Several antiplaque agents are being available in the market. However, due to several undesirable side effects associated with these agents stimulated the search for alternate agents (Jagdish L et al 2009 p.30).Hence the purpose of this study is to compare the effect of herbal and chemical mouthrinses on de novo plaque formation. Hence the aim of this double blinded, randomized controlled study is to assess and compare the effectiveness of the herbal mouthrinse (Hiora) against chlorhexidine mouthwash.

Materials and methods
This study was designed to compare the effectiveness of the herbal mouthrinse (Hiora) against chlorhexidine mouthwash. Ethical clearance was obtained from the Institutional Review Board of Coorg Institute of Dental Sciences, Virajpet. A total of 30 subjects were invited to participate voluntarily in the project and Consent was taken from all the participants by explaining about the study, objectives, reasons, duration and possible risks of the study procedures. The study population comprised dental students, which is an interesting group for this kind of study, taking into consideration that they can be easily controlled in terms of compliance. Subjects were randomly assigned to the test (HiOra mouthrinse) and control (Chlorhexidine) group.At the baseline -the volunteers brushed their teeth using toothpaste without any active ingredient for 2 minutes. Oral prophylaxis was performed to ensure that the teeth were free of plaque, stains and calculus. During the trials, the test group was given the herbal mouthrinse (Hiora) and the control group was given Chlorhexidine. All subjects were instructed to use their allocated products 15 ml per 3 minutes twice a day for a week. All participants were instructed to refrain from using any other oral hygiene measures. Both the mouthrinses were packed in similar coloured bottles, but labelled differently and randomly administered to the subjects by a blinded operator. The subjects were also unaware of which mouthrinse they are being administered. After one week, the subjects returned to the clinic for the clinical assessments. The day prior to the final assessment, oral hygiene was suspended for 24 hours, and the accumulated plaque was revealed with erythrosine. All measurements were conducted under the same conditions by a qualified, experienced examiner who had participated in similar studies. Plaque was assessed using the modified Quigley & Hein Plaque Index.
Inclusion criteria: 1) People who are older than 18 years. 2) Systemically healthy and having at least 24 teeth. Exclusion criteria: 1) Orthodontic appliances or removable prosthesis.
3) Use of other drugs that might affect normal gingival health.
Data analysis included descriptive statistics such as frequency distribution and cross tabulation. Descriptive statistics was computed and Data analysis was done using the unpaired t-test at a significance level of 5% (p <0.05). The data was analysed by using SPSS version 17.

Results
Of the 30 subjects (9 females, 21 males aged 20-25 years) who started, all of them completed the study and were deemed evaluable for analyses. Mean Age of the study subjects was 22.4 ± 0.92. Table 1 and Graph 1 shows the mean PI values for the two mouth rinses used. There were no significant differences (p > 0.05) found between HiOra mouthrinse and Chlorhexidine.

Discussion
This clinical study aimed to compare the inhibition of plaque formation by a Chlorhexidine mouthrinse with that by mouthrinses containing herbal contents. The experimental protocol consisting of no oral hygiene for one day has been used previously because plaque formation can be measured in a short period without causing detectable harm to the study subjects (Rivera S  . It is considered the gold standard of chemical anti-plaque agents against which the efficacy of other antimicrobial and antiplaque agents is assessedmainly because of its broad spectrum of activity against most of the oral pathogens (Fardal O et al 1986 p.863). In spite of potent antiplaque and antimicrobial properties of Chlorhexidine, its widespread and prolonged use is limited by its local side effects. Chlorhexidine mouth rinses are the gold standard for the inhibition of plaque formation; however, most of these effective formulations have high alcohol content, and they are, consequently, inappropriate for some patients ( The anti-plaque effect of the high bio-available, alcohol-free herbal mouthrinse in this study demonstrates that it is not different from chemical mouthrinse with chlorhexidine. It is suited for a broad range of patients, particularly those sensitive to products containing alcohol and those allergic. It has substantial future implications that these ayurvedic mouthrinses can be promoted by dentist as they have equal plaque reduction efficacy as compared to chlorhexidine with lesser or no side effects.

Conclusion
This preliminary study proves that Herbal mouthrinses are as effective as chlorhexidine in plaque inhibition. So these ayurvedic preparations can be used in regular dental practice for prevention of plaque formation.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.

Footnotes
Source of Support: Nil. Conflict of Interest: None declare