|Year : 2015 | Volume
| Issue : 3 | Page : 222-227
Evaluation of efficacy of a commercially available herbal mouthwash on dental plaque and gingivitis: A double-blinded parallel randomized controlled trial
Sanjukta Bagchi, Sabyasachi Saha, GV Jagannath, Vamsi Krishna Reddy, Pooja Sinha
Department of Public Health Dentistry, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow, Uttar Pradesh, India
|Date of Web Publication||14-Sep-2015|
Department of Public Health Dentistry, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Aim: To evaluate if a commercially available herbal mouthwash, can be a better choice as an anti-plaque and antigingivitis agent when compared with chlorhexidine. Materials and Methods: In a double-blind, parallel group randomized clinical trial 90 nursing students aged 18-25 years were randomly divided into three groups: A (chlorhexidine), B (HiOra) and C (distilled water). These groups were asked to rinse with their respective mouthwash two times daily for 21 days. Plaque and gingivitis were evaluated by using Turesky et al. modification of Quigley Hein Plaque Index (1970) and Modified Gingival Index by Lobene et al. (1986) respectively. Statistical analysis was done using ANOVA test. Results: There was statistically significant reduction in plaque and gingival scores from baseline to 21 days in both the groups A and B. Conclusions: Although chlorhexidine group proved to be the best anti-plaque and antigingivitis agent, it was found that HiOra group also showed gradual improvement from baseline to 21 days. Whereas no improvement was seen in the Group C using distilled water over 21 days.
Keywords: Anti-plaque agents, chlorhexidine, herbal mouthwash
|How to cite this article:|
Bagchi S, Saha S, Jagannath G V, Reddy VK, Sinha P. Evaluation of efficacy of a commercially available herbal mouthwash on dental plaque and gingivitis: A double-blinded parallel randomized controlled trial. J Indian Assoc Public Health Dent 2015;13:222-7
|How to cite this URL:|
Bagchi S, Saha S, Jagannath G V, Reddy VK, Sinha P. Evaluation of efficacy of a commercially available herbal mouthwash on dental plaque and gingivitis: A double-blinded parallel randomized controlled trial. J Indian Assoc Public Health Dent [serial online] 2015 [cited 2018 Dec 16];13:222-7. Available from: http://www.jiaphd.org/text.asp?2015/13/3/222/165210
| Introduction|| |
Plaque is the primary etiological factor in gingival inflammation. Oral hygiene failure results information of pathogenic plaque.  Therefore, plaque control represents the cornerstone of good oral hygiene practice.  The mechanical supragingival plaque control includes the toothbrush, floss, woodsticks, and interdental brushes. However, the degree of motivation and skill required for the effective use of these oral hygiene products may be beyond the ability of the majority of patients.  Hence, a chemical plaque control approach is desirable to deal with the potential deficiencies of daily self-performed oral hygiene.
Chlorhexidine is regarded as the "gold standard" anti-plaque agent.  However, it is not a "Magic Bullet" due to certain side effects like tooth staining, taste disturbance, etc.  It has served the dental profession over three decades and has also been recognized by the pharmaceutical industry as the positive control, against which the efficacy of alternative anti-plaque agents should be measured. 
Natural herbs such as triphala, tulsi patra, jyestiamadh, neem, clove oil, pudina, ajwain, and many more used either alone or in combination have been scientifically proven to be safe and effective against various oral health problems such as bleeding gums, halitosis, mouth ulcers, and preventing tooth decay. The major strength of these natural herbs is the absence of any side effects. Moreover, these do not contain alcohol and sugar found in most other over-the-counter products. The microorganisms feed on these ingredients releasing by-products and cause halitosis. Thus, herbal mouthrinses promote better oral hygiene and health. 
Thus, the aim of the study was to evaluate the efficacy of a commercially available herbal mouthwash as an anti-plaque and antigingivitis agent.
| Materials and methods|| |
The present study was a double-blind, parallel, randomized clinical trial. The clinical trial was conducted in the Department of Public Health Dentistry, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow. Ethical clearance was obtained from the Institutional Ethical Committee, and informed consent was taken from all the study participants. A study protocol and a case sheet containing general information, the format for recording plaque and gingival indices and subjective and objective symptoms was prepared. Detail flow chart of the protocol is given in [Figure 1].
The study sample consisted of 90 nursing students aged 18-25 years. Initially, all the 120 nursing students studying in the first and second year were screened, out of which 90 students were included in the study after following inclusion and exclusion criteria:
Subjects aged 18-25 years, having a minimum of 20 teeth, Turesky modification of Quigley Hein Plaque Index of 2 or more and Lobene et al. modified Gingival Index between 1.1 and 3.0 were included in the study. Criteria for exclusion were history of systemic diseases, antibiotic and periodontal therapy in past 3 months , allergy to test products such as irritation and burning sensation, desquamation of oral mucosa, subjects suffering from destructive periodontal disease, using any other chemotherapeutic anti-plaque/antigingivitis products and having severe malalignment of teeth, orthodontic appliances, fully crowned teeth, and removable partial dentures.
The study was carried out by a single investigator who was trained and calibrated. Kappa coefficient value for intra-examiner reproducibility was 0.86.
In order to bring the plaque and gingival scores to baseline, thorough oral prophylaxis was performed on all the subjects 15 days before the start of the study. This enabled the examiner to ensure that any presence of mild gingival and the periodontal problem would subside during this 2 week period.
The indices used for recording plaque were Turesky et al. modification of Quigley Hein Plaque Index (1970), and gingivitis was Modified Gingival Index by Lobene et al. (1986). , The subjects were recalled after 15 days for recording of baseline scores of plaque and gingivitis. The allocation sequence was concealed from the researcher enrolling and assessing participants in sequentially numbered, opaque, sealed, and stapled envelopes. Aluminum foil inside the envelope was used to render the envelope impermeable to intense light. The 90 participants were randomly assigned following simple randomization procedures using lottery method into three groups comprising 30 in each group:
Each subject was identified by a code. All the mouthwashes were dispensed in identical looking plastic bottles measuring 150 ml which were coded as A, B, and C. The mouthwashes were distributed among the subjects during each successive visit. Group allocation and dispensing of the mouthwashes was independently performed by a separate investigator. In the study, both the investigator and the subjects were blinded.
- Group A: 0.2% chlorhexidine gluconate mouthwash (positive control)
- Group B: Herbal mouthwash (test group; HiOra R mouthwash manufactured by The Himalaya Drug Company)
- Group C: Distilled water (control group or placebo).
All the subjects were instructed to rinse twice daily with 10 ml of the allocated mouthwash (undiluted) for 1 min, after 30 min of brushing their teeth. Subsequent rinsing with water was not allowed. They were provided with measuring cups with 10 ml marking in order to use the correct volume of mouthwash. They were also asked to brush their teeth with a soft nylon toothbrush and a nontherapeutic, low abrasive dentifrice. The mouthrinsing was performed at home without supervision. To check for compliance, the subjects were asked to note the times of day when they used mouthwash. The quantity of mouthwash given to the subjects was precalculated at every visit. At each recall, they were asked to bring the bottles to assess the volume of mouthwash. This gave a view whether the subjects rinsed correctly with prescribed mouthrinse or not.
During first recall at 14 th day, both the indices along with subjective (such as taste acceptability, burning sensation, dryness, or soreness of mouth) and objective (such as staining of teeth, staining of tongue, ulcer formation, and allergy) symptoms were recorded. The subjects were instructed to follow the routine plaque control measures and were recalled after 1-week. At 21 st day, the subjects were again assessed for plaque and gingivitis and any reported side effects.
SPSS version 16 (IBM Corporation) was used for statistical analysis. Intergroup comparison of plaque and gingivitis scores were done using ANOVA test. The level of significance was kept as P < 0.05.
| Results|| |
In the groups A and B, there was statistically highly significant reduction in mean plaque scores between baseline and 14 days (Group A; 1.35 vs. 0.98 and Group B; 1.52 vs. 1.17); between baseline and 21 days (Group A; 1.35 vs. 0.75 and Group B; 1.52 vs. 0.89) [Table 1].
In the groups A and B, there was statistically highly significant reduction in mean gingival scores between baseline and 14 days (Group A; 2.06 vs. 1.70 and Group B; 2.05 vs. 1.43); between baseline and 21 days (Group A: 2.06 vs. 0.75 and Group B: 2.05 vs. 1.42) [Table 2].
Regarding taste acceptability, all the thirty subjects (100%) in Group B reported the taste of herbal mouthwash as acceptable. Regarding reported burning sensation of the mouth, Group B subjects (100%) did not experience any such symptom till the 21 st day. However, in Group A, 20 subjects (67%) on the 14 th day and 24 subjects (80%) on the 21 st day reported burning sensation. Regarding the symptom of dryness or soreness, none of the subjects in Group B reported such symptom. In Group A, two subjects (7%) reported feeling the dryness of mouth [Table 3].
|Table 3: Intergroup comparison with respect to subjective symptoms at 14th and 21st day |
Click here to view
As far as objective symptoms were considered, none of the subjects in three groups had any staining of teeth or tongue, ulcer formation or allergic reaction following the use of their mouthrinses.
| Discussion|| |
Human dental plaque is one of the ecosystems in which a maximum number of microorganisms are observed. The plaque biofilm has been attributed to as one of the main etiologic factor for the two most common oral diseases; dental caries and periodontal diseases. Though, a wide array of anti-plaque agents are available in the market, their cost, unfavorable side effects, rise in bacterial resistance to antibiotics and need for an affordable anti-plaque agent has led to considerable interest in the development of the other classes of antimicrobials.  Such efforts are exploring alternative allopathic drugs, ayurveda - the traditional system of medicine in India being the next widely explored one. 
Since ancient times, natural herbs such as neem, tulsi, clove oil, ajwain, and others used alone or in combination have been significantly proven to be safe and effective medicine against oral problems such as bleeding gums, halitosis, mouth ulcers, and tooth decay. The major strength of these natural herbs is that their use has been reported with little or no side effects. 
According to World Health Organization estimates, more than 80% of the people in developing countries depend on the traditional medicine for their primary health needs.  It is generally estimated that over 6000 traditional plants in India are used in folk and herbal medicine.  Recently, numerous studies have been conducted to verify the enormous wealth of medicinal plants and their effects on oral health. The herbal mouthwashes are gaining popularity as they contain naturally occurring ingredients called as phytochemicals that achieve the desired antimicrobial and anti-inflammatory effects. Herbal formulations may be more appealing because they work without alcohol, artificial preservatives, flavors, or colors. 
One of the recently marketed herbal mouthwashes is HiOra R (manufactured by The Himalaya Drug Company, Bengaluru, Karnataka, India). It is a herbal preparation, made from a combination of natural herbs with beneficial properties of anti-cariogenic and anti-plaque due to the presence of Pilu (Salvadora persica) 5 mg,  antibacterial, anti-inflammatory, and immunity booster due to Bibhitaka (Terminalia bellerica) 10 mg,  antioxidant, antimicrobial, and plaque inhibiting properties due to Nagavalli (Piper betle) 10 mg.  Essential oils of Gandhapura taila (Gaultheria fragrantissima) 1.2 mg possess antimicrobial, anti-inflammatory, and analgesic properties.  Oil extracted from Ela (Elettaria cardamomum) 0.2 mg is a potent antiseptic that is known to kill bacteria-producing bad breath.  Peppermint satva (Mentha spp.) 1.6 mg acts as a natural mouth freshener. Yavani satva (Trachyspermum ammi) 0.4 mg also has antimicrobial properties.  S. persica is one among the most commonly used antibacterial agent in traditional ayurvedic medicine. Its role as an anti-plaque agent has been reported extensively. ,,,
The current study findings revealed that the anti-plaque and antigingivitis effects of herbal mouthrinse was similar to that of 0.2% chlorhexidine mouthrinse and significantly better than rinsing with distilled water. The findings of the study were similar to the studies conducted by Rahmani et al. and Ghazi et al. who compared the anti-plaque and antigingivitis effect of a mouthwash containing S. persica with 0.2% chlorhexidine and showed improvement in both plaque and gingival index (GI) scores. ,
The 21-day experimental gingivitis model given by Loe et al. was used as the clinical method to test the efficacy of oral mouthrinses.  This model had been previously used in many studies and has consistently shown its reliability, validity, responsiveness, and interpretability. Originally, this model was adopted to investigate the influence of a compound on the development of plaque and gingivitis in the absence of mechanical oral hygiene. The present study, however, differed from the original study model in that the subjects instead of total abstinence from oral hygiene; the mouthwash was used as an adjunct to tooth brushing. Such a study design assesses the actual effectiveness of the mouthwash in a real life situation.
The age selected for the study population is 18-25 years as the prevalence of gingivitis and occurrence and reoccurrence of periodontal disease is high from young age in all population.  Gingivitis is one of the most common forms of periodontal disease and around 100% of people aged 17-22 have gingivitis in different degrees. 
In the present study, the improvement in plaque scores between baseline and 21 days for Group A was 4.42%. While the improvement in Group B was 4.17%. Thus, it can be inferred that the efficacy of the herbal mouthrinse was almost at par as that of chlorhexidine in reducing plaque accumulation. This was similar to the studies done by Narayan and Mendon in and Bhat et al. which compared the efficacy of herbal and chlorhexidine mouthrinses on dental plaque formation and concluded that both the mouthrinses were effective as anti-plaque agents. ,
With regard to gingival scores, the magnitude of difference between baseline and 21 days for Group B was 3.06% and Group A was 3.05%, which indicate that the herbal mouthrinse has an equal efficacy in reducing gingivitis due to its astringent, antimicrobial, and anti-inflammatory properties and antibacterial effects of S. persica on periodontal pathogens, particularly Bacteroides species. 
Among Group C subjects using distilled water, no improvement was seen in mean plaque and gingival scores over 21 days which was similar to the study by Scherer et al. who found lower Loe and Silness GI scores with herbal mouthwash as compared to distilled water.  Khalessi et al. in their study concluded better plaque control efficacy of persica containing mouthwash with that of a placebo. 
Chlorhexidine till date is the proven most effective anti-plaque agent.  Its efficacy can be attributed to its bacteriostatic and bactericidal properties.  However, its prolonged use is limited due to local side effects including extrinsic tooth and tongue brown staining, taste disturbance, enhanced supragingival calculus formation, and desquamation of the oral mucosa. On the other hand, herbal mouthwash due to its natural ingredients has no reported side effects and can serve as a good alternative to patients who wish to avoid alcohol (e.g., Xerostomics), sugar (e.g., Diabetics), any artificial preservatives and colors in their mouth rinses. 
The study is not without its limitations. A crossover design with wash off period could have been more reliable study design as it eliminates the bias of variable host response. Furthermore, a longer period study could throw light on the long-term advantages and disadvantages of the herbal mouthwash. Further research to establish the level of substantivity, plaque inhibition, safety, and microbial parameters is necessary before this product finds a place among the other agents for daily plaque removal. The findings of the current study can be applied to other clinical settings and public health programs.
| Conclusion|| |
Both 0.2% chlorhexidine gluconate and HiOra R mouthwashes can be effectively used as an adjunct to mechanical plaque control in the prevention of plaque and gingivitis. However, owing to the side effects reported due to the use of chlorhexidine mouthrinse and biocompatibility and well acceptance of HiOra R mouthwash by the subjects, it can be effectively used as an alternative to chlorhexidine mouthrinse.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]