|Year : 2020 | Volume
| Issue : 2 | Page : 140-144
Comparative evaluation of the efficacy of Triphala gel and chlorhexidine digluconate gel in management of patients with chronic gingivitis: A randomized clinical trial
Snehal R Ambhore, Ashvini M Padhye
Department of Periodontics, Mahatma Gandhi Mission’s Dental College and Hospital, Navi Mumbai, Maharashtra, India
|Date of Submission||16-Aug-2019|
|Date of Acceptance||25-Oct-2019|
|Date of Web Publication||28-Mar-2020|
Dr. Snehal R Ambhore
Mahatma Gandhi Mission’s Dental College and Hospital, Junction of NH4 Sion Panvel Expressway, Sector 18, Navi Mumbai 410209, Maharashtra.
Source of Support: None, Conflict of Interest: None
Aim: To evaluate the efficacy of Triphala gel and chlorhexidine digluconate gel in the management of patients with chronic gingivitis. Materials and Methods: A total of 46 subjects diagnosed with mild to moderate chronic gingivitis were enrolled for this study after obtaining their informed consent. In their first visit, a detailed case history was recorded including gingival index, plaque index, and sulcus bleeding index at baseline; then full-mouth scaling and polishing was performed on the first visit by a single calibrated examiner. These subjects were then randomly allocated using computer-generated random numbering sequence method into two groups. Subjects in group A received Triphala gel (HiOra-GA gel, Himalaya Drug, Bengaluru, India) and group B received chlorhexidine digluconate gel (Hexigel, ICPA Health Products, Mumbai, India) for home application. The posttreatment follow-up examinations for gingival index, plaque index, and sulcus bleeding index changes were assessed after 14 days at second visit and 28 days at third visit and compared with baseline data. Results: The mean gingival, plaque, and sulcus bleeding index scores significantly decreased after 14- and 28-day intervals as compared to baseline scores with no significant difference in both the groups. Conclusion: Both Triphala gel and chlorhexidine digluconate gel were effective when used along with oral prophylaxis in the management of subjects with chronic gingivitis. Hence, Triphala gel can be considered as an alternative to chlorhexidine digluconate gel in the management of chronic gingivitis.
Keywords: Chlorhexidine, Gingivitis, Herbal, Plant-based Gel, Triphala
|How to cite this article:|
Ambhore SR, Padhye AM. Comparative evaluation of the efficacy of Triphala gel and chlorhexidine digluconate gel in management of patients with chronic gingivitis: A randomized clinical trial. J Int Oral Health 2020;12:140-4
|How to cite this URL:|
Ambhore SR, Padhye AM. Comparative evaluation of the efficacy of Triphala gel and chlorhexidine digluconate gel in management of patients with chronic gingivitis: A randomized clinical trial. J Int Oral Health [serial online] 2020 [cited 2020 May 28];12:140-4. Available from: http://www.jioh.org/text.asp?2020/12/2/140/281489
| Introduction|| |
Gingivitis is a disease that causes inflammation of the gums, or gingivitis is the term that refers to the inflammation of the gingiva or the soft tissue of the oral cavity that immediately surrounds each individual tooth. The clinical presentation includes bleeding gums, bright red appearance of gingival tissue, and gingiva that depicts tenderness to palpation, however painless yet swollen. The chief aggravating factor that causes inflammation of the gingival tissue is the occurrence of bacterial biofilm, also called dental plaque, on the surfaces of teeth or on gingival interfaces. Histopathologic examination of the inflamed gingival tissue reveals ulcerated surface of epithelium. The repair of this ulcerated surface of epithelium depends on the proliferative activity or the regenerative activity of the gingival epithelial cells. Even though plaque tends to be the primary causative agent of gingivitis, other factors can also contribute to the development of periodontal diseases. Although the inflammation of the gingiva represents the predecessor to periodontitis, it also represents a clinically obvious risk factor for the progression of the disease and eventually loss of teeth. It has been shown that inflammation of the gingival tissue increases in severity and prevalence as age increases. The periodontal attachment loss almost always follows the inflammation of the gingiva; therefore, the aim of preventing the gingival tissue inflammation is to prevent the breakdown of the periodontal tissues, which is irreversible. However, gingivitis is a reversible disease.
The goal of treatment for chronic gingivitis is to remove the causative factors. Various agents such as antibiotics, anti-inflammatory agents, or astringents are used in the treatment of gingivitis. Astringents cause shrinkage and contraction of tissues by constricting small blood vessels, water extraction from tissue, or by protein extraction. As they possess fungicidal, anesthetic, germicidal, and healing properties, they are used for the treatment of gingival bleeding, oral stomatitis, and inflammation.
Topical antiseptics also include chlorhexidine that has remained as one of the most effective agents reported till date and has been successfully used for the management of biofilm-induced gingivitis. Chlorhexidine digluconate gel (1%) is widely used at institutions and can be easily applied with toothbrushes or trays. However, chlorhexidine is associated with various side effects such as allergy, altered taste sensation, and dry mouth. The early signs and symptoms of allergy may be mild but reapplication can cause a fatal reaction, and therefore, even the mild early reactions should not be ignored.
Triphala gel is a herbal product containing extracts of Terminalia arjuna, Triphala, Pterocarpus marsupium, and oils of Myristica fragrans, all of these are known to be soothing and have healing properties for connective tissues along with antimicrobial and anti-inflammatory properties. The useful effects of Triphala gel are due to the additive effects of the potency of the individual herbs with their anti-inflammatory, antioxidant, wound-healing, antibacterial, and analgesic properties. Although Triphala is generally considered safe and has potential health benefits, it may cause side effects in some people. For example, owing to its natural laxative effects, it may cause diarrhea and abdominal discomfort, especially in high doses. Triphala is not recommended for pregnant or lactating women and should not be administered to children. There are no scientific studies on the use of Triphala in these populations, and its safety cannot be guaranteed. Furthermore, it may interact with or decrease the effectiveness of certain medications, including blood thinners such as warfarin. It may increase the risk of bleeding and bruising in certain people and may not be safe for those with bleeding disorders. However, Triphala in the form of gel quite effectively relieves symptoms of chronic gingivitis such as gingival swelling, gingival bleeding, and halitosis with no adverse effects.
To overcome side effects of chlorhexidine, various other preparations have been used. No side effect has yet been reported of these natural herbs when used for gingivitis. A few studies performed by Salgado et al., Ozaki et al., Samuels et al., and Stoeken et al. have found herbal products to be effective in reducing plaque and gingival inflammation. As limited data are available on Triphala gel, this study was aimed to evaluate and compare Triphala gel and chlorhexidine digluconate gel in the treatment of chronic gingivitis.
| Materials and Methods|| |
Sampling method and size calculation
This randomized prospective in vivo study was conducted in the department of periodontics from February 2019 to May 2019. The sampling method was randomized convenience sampling, and the sample sizes were calculated in two different ways: first, using the T statistic (with a non-centrality parameter), then using the Z statistic, the Z statistic approximated the T statistics and provided a sample size of 34 subjects. The sample size was expanded by 10% to compensate for dropouts. Therefore, 46 subjects with chronic gingivitis fulfilling the following eligibility criteria were selected. Ethical clearance for research was obtained from the institutional ethics committee of the Mahatma Gandhi Mission’s Dental College and Hospital (IERC MGMDCH reference no 47/8)
Subjects diagnosed with mild to moderate chronic gingivitis, aged 20–45 years rendering informed consent, and possessing minimum of 20 natural permanent teeth excluding third molar were included in the study. Subjects with a known history of allergy to any chemical or herbal products used in this study, individuals with a history of use of antibiotics or any other drugs within the last 3 months, pregnant women and lactating mothers, subjects who had periodontal pockets more than 6 mm, subjects with removable or fixed appliances, medically compromised subjects, and subjects with deleterious habits (e.g., tobacco smoking, pan chewing, and tobacco chewing) were excluded from the study.
The observation was carried out by single calibrated examiner. Bias was tackled by including same number of male and female subjects in the study between the age-group of 20–45 years. After recording detailed case history in first visit, subjects underwent full mouth gingival examination for recording gingival index (GI) by Löe (1967), plaque index (PI) by Löe, and sulcus bleeding index (Muhlemann and Son, 1971). After full-mouth scaling, subjects in group A received Triphala gel (HiOra-GA gel, Himalaya Drug, Bengaluru, India) and group B received chlorhexidine digluconate gel (Hexigel, ICPA Health Products, Mumbai, India) for home application. Subjects were instructed to take a pea size portion of the agent on the index finger and gently massage all over the gingiva for 1min, twice a day for 28 days. Home maintenance chart was given to the subjects to evaluate the compliance. The subjects who missed the application of gel were excluded from the study. The subjects were reevaluated for the GI, PI, sulcus bleeding index, and home maintenance with the help of home maintenance chart at 14 and 28 days. Twelve subjects, six in each group, were dropped out from the study because they were lost during follow-up.
The measurements were recorded by the examiner manually at the time of examination and transferred to data tables made in Microsoft Excel spreadsheet for tabulation. Data were analyzed using the statistical package R programing software which is statistical programing software. Then, t test or Mann–Whitney U test was used on conforming normality. Level of significance was set at P < 0.05 for statistical significance.
| Results|| |
No statistically significant difference was observed in the mean gingival scores of subjects in different intervention groups at baseline as well as at different time intervals. However, there was reduction in the gingival score of subjects between baseline and post-intervention in each group as shown in [Table 1]. In case of group A, the mean GI score decreased from 0.99 ± 0.25 at baseline to 0.45 ± 0.22 after 28 days. Same results were reported with group B, it decreased from 0.88 ± 0.07 at baseline to 0.36 ± 0.18 after 28 days. Two-tailed P value was 0.95.
|Table 1: Comparison of the gingival index scores at baseline, day 14, and day 28 in group A and group B using Mann–Whitney U test|
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No statistically significant difference was observed in the mean plaque scores of subjects in different interventions at baseline as well as at different time intervals in both groups. [Table 2] shows reduction in plaque score of subjects between baseline and post-intervention in group A and group B. PI reduced from 1.18 ± 0.26 to 0.57 ± 0.22 from baseline to 28 days in Group A, and in Group B, it reduced from 1.06 ± 0.18 to 0.51 ± 0.26 from baseline to 28 days. Two-tailed P value was 0.43.
|Table 2: Comparison of the plaque index scores at baseline, day 14, and day 28 in group A and group B using Mann–Whitney U test|
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Also, no significant difference was observed in sulcus bleeding index at different intervals, but it reduced from first visit to third visit as shown in [Table 3] (from 0.29 ± 0.7 to 0.19 ± 0.16 in group A and from 0.29 ± 0.10 to 0.12 ± 0.04 in group B). Two-tailed P value was 0.43. The significant difference was seen in sulcus bleeding index at 28 day on intergroup comparison as p value is less than 0.05 i.e., p = 0.033. As the level of significance was set at P < 0.05, P value less than 0.05 was suggestive of significant difference.
|Table 3: Comparison of the sulcus bleeding index scores at baseline, day 14, and day 28 in group A and group B using Mann–Whitney U test|
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| Discussion|| |
Universally accepted means for maintaining adequate oral hygiene levels are mechanical plaque control methods. However, it is difficult by majority of population to use complete mechanical plaque control methods. Owing to this reason, many chemotherapeutic agents have been evolved to control bacterial plaque. The aim of these agents is to improve the efficacy of routine oral hygiene measures. There is an increasing use of medicinal plants and herbal medicines, which contribute significantly to the health of humanity worldwide, especially in the developing countries. The limited scientific knowledge among the general population has led to the general assumption that herbal medicines being natural are therefore safe. However, evidence is being adduced from toxicological studies, which show plant products to be potentially toxic, and thus affecting their safe use. So the safety and biocompatibility of the herbal agent is yet to be proven. A growing interest in the development of plant-based herbal medicines possessing antibacterial and anti-inflammatory activities for the treatment of oral diseases has been witnessed in the last few decades. This will help to overcome side effects in relation with the extensive misuse of chemotherapeutic agents that induce microbial drug resistance.
This study assessed the efficacy of a plant-based gum astringent, that is, Triphala gel in comparison with chlorhexidine digluconate gel for 28 days. A significant reduction was found in the mean PI, GI, and sulcus bleeding index among subjects in each intervention group at different post-intervention intervals compared to baseline scores. However, no significant difference was observed in the efficacy of these products on intergroup comparison. The reduction in the plaque scores in each group suggested the antibacterial efficacy of these gels, especially along with mechanical debridement carried out after baseline examination. Triphala gel (HiOra-GA gel), which was used in this study, contains some herbal products. These herbal products include Jatiphala (M. fragrans), Triphala, Asana (P. marsupium), and Arjuna (T. arjuna). Antimicrobial efficacy is attributed to phytochemical constituents present in herbal extracts, which are there in gel. These results were in agreement with the results of a study conducted by Apoorva et al. They found HiOra-GA gel to be effective in reducing plaque and gingival inflammation. Triphala is a recommended medicinal remedy in the treatment of gingivitis since many years. Gupta et al. have suggested the antimicrobial efficacy of Triphala extracts, that is, aqueous and ethanolic extracts on primary plaque colonizers in their in vitro study. Prakash and Shelke also found the effectiveness Triphala in reducing plaque and controlling gingivitis in their study. A similar study has been conducted by Jeyaraj and Chithresan, which was a randomized, double-blind, placebo-controlled study that showed significant reduction in the gingival swelling and bleeding and also tenderness and halitosis with the usage of HiOra-GA gum astringent.
In a study conducted by Nittayananta et al. to evaluate the efficacy of chlorhexidine to control gingivitis and Candida species in subjects infected with the human immunodeficiency virus, it was found that there was a decrease in gingivitis and in the number of Candida species after brushing with chlorhexidine gel twice a day for 2 weeks at home. Das et al. compared the efficacy of HiOra-GA gel with that of Hexigel for the management of patients with gingivitis, and they concluded that HiOra-GA gel and Hexigel are equally effective in the treatment of gingivitis. Also, the results of a study conducted by Sukhabogi et al. indicated that the products such as HiOra-GA gel and Spirogyl Gum Paint may be used as adjuncts in mechanical plaque control methods. Pradeep et al. concluded that improvement in gingivitis by Triphala mouthwash was comparable to that of chlorhexidine mouthwash; thus, Triphala mouthwash can be considered as a potential therapeutic agent in the treatment of gingivitis. A review conducted by Safiaghdam et al. on medicinal plants for gingivitis supported the efficacy and safety of several medicinal plants for gingivitis. Bhardwaj et al. evaluated and compared the effects of topical subgingival application following scaling and root planing of xanthan-based chlorhexidine gel as compared with a gel containing chlorhexidine and metronidazole and scaling and root planing alone, and they concluded that xanthan-based chlorhexidine gel showed maximum reduction in the percentage of occurrence for Porphyromonas gingivalis and almost same reduction for Actinobacillus actinomycetemcomitans and Fusobacterium species.
Therefore, in case of the usage of individual topical gel, the results of our study are similar with the results of other studies conducted earlier, suggesting the oral formulations of the drugs are safe and effective for gingivitis. When the results of group A and group B are compared, the mean values show no significant difference, thereby denoting both the topical gel to be equally effective for the treatment of gingivitis. However, more multicentric and longitudinal studies are needed to fully evaluate the potential benefits and challenges of these gels in the treatment of gingivitis.
The strength of this study was that it critically evaluates the clinical efficacy of Triphala gel (Himalaya Drug) and chlorhexidine digluconate gel (ICPA Health Products) in the treatment of gingivitis. This study highlighted clinical advantages of using Triphala gel and chlorhexidine digluconate gel in subjects having gingivitis. However, several limitations must be considered in interpreting the result of this study. First, the study was limited to 3 months, and hence, a longer duration of clinical observation will be more effective in evaluating the subject’s gingival status. Second, multiple periodontal conditions such as periodontitis, aggressive periodontitis, peri-implant mucositis, and peri-implantitis should also be studied for understanding the clinical outcome of Triphala gel and chlorhexidine digluconate gel.
From this study, it can be concluded that Triphala gel and chlorhexidine digluconate gel are equally effective in the treatment of gingivitis. As there are many adverse effects of chlorhexidine digluconate gel, Triphala gel can be considered as an alternative to chlorhexidine digluconate gel in the subjects with gingivitis. Similar studies with larger sample sizes and longer follow-ups should be carried out to compare the efficacies of both the gels. However, the efficacy of Triphala gel and chlorhexidine digluconate gel needs to be evaluated in subjects having advanced periodontal disease.
Ethical policy and institutional review board statement
Ethical clearance for research was obtained from the institutional ethics committee of the Mahatma Gandhi Mission’s Dental College and Hospital (IERC MGMDCH reference no 47/8) and clinical trial registration number was CTRI/2019/01/017290. During the conduct of the study, all human ethical principles as per the World Medical Association’s Declaration of Helsinki (2013) and the guidelines of Good Clinical Practice (Indian Council of Medical Research) were observed.
Financial support and sponsorship
This study was self-funded by the authors.
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]