The comparative effects of 0.12% chlorhexidine and herbal oral rinse on dental plaque-induced gingivitis: A randomized clinical trial.

BACKGROUND: Chlorhexidine (CHX) is considered as a gold standard of antimicrobial rinses. Various herbal oral rinses are available in the market. However, little is known of its effectiveness. AIM: The aim of this study was to evaluate the clinical changes after the usage of herbal oral rinse and 0.12% CHX.
MATERIALS AND METHODS: In a randomized clinical trial, 76 patients with dental plaque-induced gingivitis were assigned to Group I (Herbal Oral Rinse - Hiora(®)) and 76 patients with dental plaque-induced gingivitis to Group II (0.12% Chlorhexidine-Peridex(®)). Gingival index and Plaque index scores were recorded at baseline and 21 days after scaling.
RESULTS: Intragroup comparison in both groups showed that plaque index and gingival index scores were statistically significant after 21 days as compared to baseline. Intergroup comparison showed that plaque index scores and gingival index scores were statistically significant in Group II as compared to Group I.
CONCLUSION: When herbal oral rinse was compared to 0.12% CHX, 0.12% CHX mouth rinse effectively reduced the clinical symptoms of plaque-induced gingivitis.

RCT Entities:   Population Interventions Outcomes

INTRODUCTION

Bacterial plaque is the primary etiological cause of gingivitis.[1] Mechanical plaque control is largely the responsibility of the individual using toothbrushes and interdental cleaning devices. Despite one's best efforts, mechanical aids fail to adequately remove plaque biofilm, for which chemical plaque control is often recommended as an adjunct to mechanical plaque control to help maintain gingival health.

A number of chemical agents like phenolic compounds, bis-biguanides, pyrimidines, quaternary ammonium compounds, oxygenating agents, halogens, heavy metal salts which have antiseptic or antimicrobial action have been used, with variable success, to inhibit plaque formation and the development of gingivitis.[2] Chlorhexidine (CHX) is the most studied and effective antiseptic for plaque inhibition and prevention of gingivitis when used twice daily as mouth rinse.[3] CHX besides its side effects including: Brown discoloration of the teeth, some restorative materials and mucosa; bitter taste and a slight increase in supragingival calculus formation is known as “Gold Standard” of antimicrobial rinses because of broad-spectrum activity and substantivity of 8–12 h.[45]

In order to overcome such side effects the World Health Organization advice researchers to investigate the possible use of natural products such as herb and plant extracts. A number of clinical studies have shown the effects of using mouthwashes extracted from herbs such as Myrtus communis, Qureucus infectoria, Capparis spinosa, and Cinnamon in the prevention of dental plaque accumulation and subsequent gingival inflammation.

There is the minimum evidence that proves the efficacy of herbal mouth rinses and their ability to control plaque-induced gingivitis. Thus, the aim of this study was to evaluate the clinical changes after the usage of herbal oral rinse and 0.12% CHX.

MATERIALS AND METHODS

This randomized controlled clinical trial was carried out in the Department of Periodontology and Implantology, M A Rangoonwala College of Dental Sciences and Research Center, Pune.

The study population consisted of 152 individuals, who were systemically healthy, between 20 and 50 years of age and with moderate to severe plaque-induced gingivitis were enrolled in the study. They were equally distributed in the test (n = 76) and the control group (n = 76). Participants were excluded from the study if they suffered from nonplaque induced gingivitis or periodontitis, history of antibiotic use and use of any form of herbal products in the last 90 days, need for antibiotic premedication, patients using mouth rinse within the last 3 months, pregnant women, habit of smoking or any form of smokeless tobacco and with systemic diseases. Patients were selected on the basis of inclusion and exclusion criteria and were randomly assigned using a coin toss to:

Group I (Test Group): Hiora® herbal oral rinse that consists of Piper betle (Nagavalli), Bhibhitika (Terminalia bellerica), Pilu (Salvadora persica) commonly known as meswak, Gandharpura tailum, Yavani, Ela, Peppermint satva

Group II (Control group): Peridex® that consists of 0.12% CHX.

The examiner and participants were blinded to product allocation.

The clinical examination included gingival index (Loë and Silness, 1967) and plaque index (Silness and Loë, 1964) which were recorded at baseline and postoperatively after 21 days. Oral hygiene instructions were given to all the participants at the baseline. The selected individuals underwent scaling following the baseline measurements. All the patients in Group I and Group II were instructed to use the assigned mouth rinse 15 ml twice daily for 30 s in conjunction to their normal oral hygiene routine. Participants from both the groups were advised to use the Colgate® medium bristle toothbrush and Colgate Total® toothpaste.

Patients were recalled at weekly interval to check for the oral hygiene and the oral hygiene was reinforced in noncompliant patients. Thus, the compliance of the patient was assessed.

Statistical analysis

Data were statistically analyzed. Between group statistical comparison of all the parameters is done using independent sample t-test after confirming the underlying normality assumption. Within group statistical comparison of all the parameters is done using paired sample t-test after confirming the underlying normality assumption of differences. The relative percentage change in both the parameters is calculated using following the formula: (Baseline - 21 days) × 100/(baseline). P < 0.05 is considered to be statistically significant.

RESULTS

Group I did not yield statistically significant results than Group II in the proportion of gingival index scores and plaque index scores of baseline parameters [Table 1].

Table 1

Intergroup comparison of baseline parameters

Plaque index scores

When within group comparison of pretreatment and posttreatment scores was done, plaque index scores of posttreatment were statistically significant [Table 2]. When between group comparison of relative percentage change in study parameters was done Group II results were statistically significant as compared to Group I [Table 3].

Table 2

Intragroup comparison of pre- and post-mouthwash treatment (Plaque Index)

Table 3

Inter group comparison of relative percentage change in study parameters

Gingival index scores

When within group comparison of pretreatment and posttreatment scores was done, gingival index scores of posttreatment were statistically significant [Table 4]. When between group comparison of relative percentage change in study parameters was done Group II results were statistically significant as compared to Group I [Table 3].

Table 4

Intragroup comparison of pre- and post-mouthwash treatment (Gingival Index)

DISCUSSION

The purpose of this study was to determine the comparative effects of herbal oral rinse (Hiora®) to 0.12% CHX (Peridex®) on gingival health and plaque accumulation over time.

Hiora® herbal oral rinse consists of P. betle (Nagavalli), Bhibhitika (T. bellerica), Pilu (S. persica) commonly known as Meswak, Gandharpura tailum, Yavani, Ela, Peppermint satva. Research by Kaim et al. suggests that there are certain ingredients in herbal oral rinses that exhibit evidence of anti-inflammatory and anti-fungal therapeutics effects.[6] S. persica (Meswak) prevents dental plaque accumulation and subsequent gingival inflammation. It is a medicinal plant that has been used by many people in Africa, South America, Middle East and Asia. S. persica contains a number of identified antimicrobials and prophylactic components including fluorides, alkaloids, sulfur compounds and volatile oils such as benzyl isothiocyanate. They alter the characteristics of the early plaque settlers Streptococcus sanguinis, Streptococcus mitis and Actinomyces species and make them less adherent. This could account for a significant reduction in the binding capacity by the extracts. The anionic components S. persica has an antimicrobial activity against Streptococcus aureus, Streptococcus mutans, Streptococcus fecalis, Lactobacillus, Pseudomonas Aeruginosa, and Candida albicans. In this regards, Almas et al. compared antimicrobial activity of eight commercially available mouth rinses and 50% Miswak extract against seven microorganisms. They found that mouth rinses containing CHX had the maximum antibacterial activity while Miswak extract had low antibacterial activity.[7] Hydrochavicol in P. betle inhibits expression of pro-inflammatory cytokine, tumor necrosis factor-α, disrupts the permeability barrier of the microbial membrane of S. mutans and Actinomyces species and also has an astringent action. Gallic acid in bibhitika has an astringent action. Methyl salicylate in Gandharpura taila, cineole in Ela, thymol in Yavani and menthol in Peppermint satva impart a fragrant and refreshing effect. Additional research conducted by Scherer et al. demonstrated that herbal oral rinse reduced gingival bleeding after 3 months of use as compared to placebo.[8]

Chlorhexidine is effective against an array of microorganisms including Gram-positive and Gram-negative organisms, fungi, yeast and viruses. It is bacteriostatic at low concentration and bactericidal at high concentrations. The ability of an oral rinse to be retained in the oral cavity and maintain potency over an extended length of time has been debated. Lang stated the substantivity of an antimicrobial agent needs sufficient contact time with a microorganism in order to inhibit or kill it.[9] CHX, with a substantivity of 12 h is considered to be highly effective; whereas, the substantivity of herbal mouth rinse is unknown.

Hence, in the present study, comparison was made between herbal oral rinse (Hiora®) and 0.12% CHX (Peridex®) to see their effectiveness. In this study, there was a statistically significant reduction in the proportion of gingival index scores and plaque index scores in the CHX group. These results correlate with studies done by Southern et al., 2000[10] and Malhotra et al., 2011.[11] However, in a study done by Chatterjee et al., 2011[12] herbal oral rinse is equally effective in reducing periodontal indices as CHX. However, there is not enough statistically significant evidence to suggest that herbal oral rinse had a greater effect in reducing gingival index scores. With the proliferation of herbal oral care products, it is important for clinicians to make evidence-based decisions when making product recommendations.

Research needs to be conducted to determine the substantivity of herbal mouth rinse as well as to determine its antimicrobial effects on gingivitis, plaque biofilm accumulation, and related bacteria. Suggestions for future studies include: (1) Expand study population to include broader disease status, and varied age group (2) extend study to 6 months (3) add stains and calculus indices.

CONCLUSION

Within the limitations of the study when herbal oral rinse was compared to 0.12% CHX, 0.12% CHX mouth rinse effectively reduced the clinical symptoms of plaque-induced gingivitis, and had a statistically significant effect on the reduction of plaque scores.