|Year : 2018 | Volume
| Issue : 1 | Page : 28-33
Efficacy of Ayurvedic drugs as compared to chlorhexidine in management of chronic periodontitis: A randomized controlled clinical study
Neelam Mittal1, Vinod Kumar Joshi2, Ratan Kumar Srivastava3, Shri Prakash Singh3
1 Conservative Dentistry and Endodontics, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India
2 Department of Dravyaguna, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India
3 Department of Community Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India
|Date of Submission||28-Aug-2016|
|Date of Acceptance||28-Feb-2018|
|Date of Web Publication||28-Feb-2018|
Prof. Neelam Mittal
Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: In India, Ayurveda is considered to be more effective and cheaper than modern medicine. Ayurvedic literature shows its use in treating oral diseases also. However, their effectiveness, in comparison with the allopathic mode of management, has not been assessed previously. The aim of this randomized controlled clinical trial was to compare the efficacy of ayurvedic drugs over chlorhexidine in treating chronic periodontitis.
Materials and Methods: Four hundred and eight participants, in the age group 20–49 years, suffering from mild-to-moderate chronic periodontitis were included in this study. Community periodontal index for treatment needs (CPITN) score was recorded, and oral prophylaxis was done for each patient. They were then randomly divided into 6 groups: control group (I), chlorhexidine (II), Khadiradi vati (III), Dashansanskar churana (IV), Neem (V), and Apamarga (VI); based on the drugs used by patients for the maintenance of oral hygiene after oral prophylaxis. Patients were recalled at 1 week, 1 month, and 3 months after oral prophylaxis. CPITN score was re-recorded for each patient at each follow-up. Reduction in CPITN score indicated improvement in the periodontal health. Observations were statistically analyzed using univariate ANOVA and P value was set at <0.5.
Results: Improvement in CPITN scores in 6 groups was as follows: I – 42.0%, II – 76.37%, III – 82.03%, IV – 83.46%, V – 78.8%, and VI – 29.9%. Higher mean percentage improvement was seen when patients used these drugs for 3 months as compared to 1 month.
Conclusion: Dashansanskar churana and Khadiradi vati showed better results than chlorhexidine and were found to be superior in managing mild-to-moderate cases of chronic periodontitis.
Keywords: Ayurveda, chlorhexidine, chronic periodontitis, periodontal index
|How to cite this article:|
Mittal N, Joshi VK, Srivastava RK, Singh SP. Efficacy of Ayurvedic drugs as compared to chlorhexidine in management of chronic periodontitis: A randomized controlled clinical study. J Indian Soc Periodontol 2018;22:28-33
|How to cite this URL:|
Mittal N, Joshi VK, Srivastava RK, Singh SP. Efficacy of Ayurvedic drugs as compared to chlorhexidine in management of chronic periodontitis: A randomized controlled clinical study. J Indian Soc Periodontol [serial online] 2018 [cited 2020 Feb 28];22:28-33. Available from: http://www.jisponline.com/text.asp?2018/22/1/28/226366
| Introduction|| |
Increased health awareness and improvements in preventive dentistry have led to decrease in tooth loss in all age groups. Increased life expectancy and greater health expectations may lead to changes in demand of individuals of all age groups for periodontal treatment and substantial increase in periodontal therapy. Advanced periodontal disease with deep periodontal pockets affects 10%–15% of adults worldwide.
Experimental studies on gingivitis provided the first empiric evidence that accumulation of microbial film on clean tooth surfaces results in the development of an inflammatory process around the gingival tissue. Local inflammation persists as long as the microbial film is present adjacent to the gingival tissues, and it may resolve subsequent to a meticulous removal of the biofilm. Therefore, current treatment is directed at disruption of biofilm which usually includes professional and home care mechanical methods. Patient cooperation in daily plaque removal is critical to long-term success of all periodontal treatments. Many patients can get effective plaque control using toothbrushes, but antimicrobial mouthwashes such as chlorhexidine, mixtures containing essential oil, and cetylpyridinium can add to the mechanical plaque removal.
Chlorhexidine has been the “gold standard” mouthwash because of its antibacterial action, efficacy, and substantivity. It is a cationic bisguanide with a broad-spectrum antiseptic with pronounced antimicrobial effect on Gram-positive and negative bacteria, yeast, dermatophytes, and some lipophilic viruses and also potent antiplaque agent. However, continuous use of chlorhexidine for long periods can cause stains on teeth, tongue, and gingival, also on silicate and resin restorations, alter taste sensation, xerostomia, ulcers, etc. Hence, it cannot be used for daily prophylactic measures.
According to the WHO, more than 80% of the world's population relies on traditional herbal medicine for their primary health care. Ayurveda is one of the traditional systems of medicine, practiced in India since ancient times. The concept of oral diseases is vividly found in original scriptures of Ayurveda, that is, Charaka Samhita and Sushruta Samhita, and herbal or herbomineral preparations with their properties, action, and therapeutic uses are well defined in them. Due to the aforementioned side effects of chlorhexidine, herbal alternatives are needed. Out of the rich reservoir of resources available in Ayurveda for treatment of periodontal diseases, two single dosage forms (Apamarga and Neem) and two compound dosage forms (Dashansanskar churana and Khadiradi vati) were selected for this study.
The aim of this randomized controlled clinical trial was to evaluate the efficacy of four ayurvedic drugs, that is, Neem, Apamarga, Dashansanskar churana, and Khadiradi vati, as compared to chlorhexidine in the management of chronic periodontitis.
| Materials and Methods|| |
This clinical trial was conducted from May 1, 2011 to November 30, 2011. This clinical trial is registered with Clinical Trial Registry – India (CTRI/2016/04/006895).
Patients in the age group of 20–49 years suffering from chronic periodontitis were selected for the study. Community periodontal index for treatment needs (CPITN) was used for screening patients. Patients with CPITN score codes 1, 2, or 3 were considered as cases of mild-to-moderate periodontitis and were included in the study. Immunocompromised patients, those with systemic diseases, and patients with CPITN score code 4 were excluded from the study.
Sample size estimation
The present study had the following assumptions to determine the sample size:
- Improvement rate in the control group: 15%
- Minimum increase in effectiveness of 25% was considered to be of practical relevance between control arm and any one of the new drug arm.
- Significance level of 5% with 1 tail probability (Type I error or α error) was taken into consideration
- Power of the test as 90%
To calculate the Trial size following formula was used:
P1= Proportion of successes in Group 1
Q1= Proportion of failure in Group 1 (=1 − P1)
P2= Proportion of successes in Group 2
Q2= Proportion of failure in Group 2 (=1 − P2)
Zα = 1.645
Zβ = 1.282
The total trial size calculated was = 101.
Therefore, in each arm, no of study participants will be = 51.
We presumed a dropout rate of 25% after 3 months of follow-up. Therefore, 408 study participants were randomized to six study arms, and it was expected to get 51 participants in each study arm after 3 months of follow-up.
Study design and enrolment of study subjects
It is a randomized controlled clinical trial to compare the effectiveness of four ayurvedic drugs, with chlorhexidine and a control group. We screened and enrolled patients with chronic periodontitis attending the dental faculty as outdoor patients applying inclusion and exclusion criteria to include in the study. Permuted block randomization (fixed) of the eligible study participants was done by a third party using sequentially numbered, sealed, and opaque envelopes.
This study was undertaken after approval from the ethical committee of the institute. Detailed treatment protocol was explained and written informed consent was taken from the patients.
Baseline CPITN scores were recorded for all the patients who consented to participate in the study. All patients underwent complete oral prophylaxis and were then randomly divided into the following six groups.
- Group I: Only oral prophylaxis (control group)
- Group II: Oral prophylaxis + use of chlorhexidine for plaque control
- Group III: Oral prophylaxis + use of Khadiradi vati for plaque control
- Group IV: Oral prophylaxis + use of Dashansanskar churana for plaque control
- Group V: Oral prophylaxis + use of Neem for plaque control
- Group VI: Oral prophylaxis + use of Apamarga for plaque control.
Preparation of the ayurvedic formulations
This compound dosage was prepared as per the ingredients and method stated in ayurvedic text (Charak Chikitsa 26/206-211).
This compound dosage was prepared as per the ingredients and method stated in ayurvedic text (Bhaisajya Ratnavali, Mukha Roga 61/97-98).
Neem (Azadirachta indica)
Powder was prepared by drying neem leaves and then grinding them to the finest form.
Apamarga (Achyranthes aspera)
Powder was prepared by drying the roots and then grinding to the finest form.
Method of application of powder
Powder was supplied to patients in small pouches in daily dose of 0.5–2 g. Patients were instructed to add powder to water in the ratio of 3:1 and applied twice daily on the gums.
Method of application for chlorhexidine
Once daily mouthwash with 10mL of 0.2% chlorhexidine for 1 minute.
Follow-up and clinical evaluation of patients
Enrolled study participants were recalled thrice for follow-up at 1 week, 1 month, and 3 months after the initial visit. Follow-up scores were also recorded using CPITN index in the following manner.
The WHO periodontal probe was used for the study. Oral cavity was divided into 6 sextants. A sextant was examined if two or more index teeth were present. Index teeth to be examined (according to Federation Dentaire Internationale numbering system): 16 (17), 11 (21), 26 (27), 36 (37), 31 (41), and 46 (47). If index teeth were missing, then teeth in brackets were examined. Scores were given to all the six teeth.
The Community periodontal index for treatment needs score criteria was as follows
- Score 0: Healthy periodontium
- Score 1: Bleeding observed during or after probing
- Score 2: Calculus or other plaque retentive factors either seen or felt during probing
- Score 3: Pathological pocket 4–5 mm in depth. Gingival margin situated on black band of the probe
- Score 4: Pathological pocket 6 mm or more in depth. Black band of the probe not visible.
The improvement in the scores was calculated by blinded outcome assessor and compared between different groups. Decrease in CPITN score was considered as the improvement in chronic periodontitis. Statistical analysis was done using univariate ANOVA and P < 0.5 was considered statistically significant.
| Results|| |
A total of 408 study participants were selected and randomized for the study in six groups. It comprised of 266 (65.2%) male and 142 (34.8%) female participants. Out of the total study participants, 236 (57.8%) participants belonged to urban areas and 172 (42.2%) were from rural areas. The participants were in the age range of 20–49 years with their mean age being 31.95 (+7.024) years. Out of these, 300 participants completed their 3-month follow-up giving a dropout rate of 26.5%. Three study arms had 51 participants, two had 50, and one had 47 study participants who completed 3-month follow-up.
CPITN scores were used to evaluate the effect of the different drug formulations. There was no statistically significant difference between the mean baseline scores of the six experimental groups. There was no statistically significant difference in the mean baseline scores of those participants who completed their 3-month follow-up and those who dropped out of the study [Table 1]. Improvement in scores after 3-month follow-up for the six groups is shown in [Table 2]. Dashansanskar churana, Khadiradi vati, chlorhexidine, and Neem had better results as compared to the control group while Apamarga showed less improvement than the control group.
|Table 1: Comparison of mean baseline score of participants who completed 3-month follow-up and those who dropped out|
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|Table 2: Baseline mean scores, 3-month postintervention mean scores, and percentage improvement in the study participants|
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Dashansanskar churana, Neem, and Khadiradi vati group showed improvement of more than 90% in 46.0%, 42.6%, and 41.2% patients, respectively. The same level of improvement was shown by only 29.4% patients in chlorhexidine group [Table 3]. This difference of improvement seen in ayurvedic drugs as compared to chlorhexidine is statistically significant. Seventy-five percent improvement level was found in 70% patients in Dashansanskar churana group followed by chlorhexidine group and Khadiradi vati group that showed such improvement in 66.67% patients each, while this figure was 63.8% in the Neem group [Table 3]. If 50% improvement is considered as acceptable, we find that Dashansanskar churana group showed this level of improvement in 100% study participants followed by 98% patients of Khadiradi vati group, 94.1% participants of chlorhexidine group, and 83% participants of Neem group. These differences were statistically significant [Table 3]. Khadiradi vati, Neem, Dashansanskar churana, and chlorhexidine groups showed improvement about 50% if used for only 1 month. This improvement in scores increased to 83.46%, 82.02%, 78.84%, and 76.37% if the duration of Dashansanskar churana, Khadiradi vati, Neem, and chlorhexidine treatment was prolonged to 3 months [Table 4]. This showed that increasing the duration of treatment increases the improvement level.
|Table 3: Percentage improvement in six study arms at different cutoff levels in the study participants|
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|Table 4: Percentage improvement with duration of treatment in four most effective drugs|
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| Discussion|| |
Originating from the ancient Indian civilization, Ayurveda caters to the needs of common man because of its ease of availability in Indian scenario. According to MEDLINE search, ayurvedic drugs are more curative, long-term effective, and cheaper than other modern medicines. Ayurvedic drugs are associated with limited or no side effects as these are indigenous preparations from natural resources. Ayurvedic drugs have been used since ancient times to treat oral diseases including periodontal diseases. Sushruta Samhita in his 20th shloka has stated that Triphala can be used as a gargling agent in dental diseases as it has antibacterial, antiseptic, and anti-inflammatory properties.
Polymorphonuclear neutrophils (PMN) provide the major source of collagenases or gelatinase that mediate connective tissue breakdown during inflammatory periodontal disease. Herbal extracts are potent inhibitors of pathologically elevated collagenases and hence may be used as an alternative adjunct in the management of periodontal disease. A meta-analysis conducted in 2016 has shown that a wide range of newer herbal mouthwashes are available, but their potential use and recommendations need to be validated. Out of the 11 analyzed studies, only two studies favored the use of herbal products while four studies favored the use of chlorhexidine. Rest of the five studies kept herbal mouthwashes and chlorhexidine at par with each other. Therefore, more studies are required to prove that herbal products can equate or replace the “gold standard” chlorhexidine.
Chlorhexidine significantly reduces dental plaque and gingivitis in patients and has been established as the most effective chemical plaque control compound. In our study also, chlorhexidine group showed better reduction in CPITN score than in control group. However, it can cause altered taste sensation, staining of teeth and tongue when used for more than 15 days. This disadvantage of chlorhexidine, along with the fact that there are no reported side effects of the four ayurvedic drugs selected for the study when used as tooth powder or in aqueous solution as oral rinse, prompted us to test these ayurvedic drugs and compare their effectiveness with chlorhexidine in chronic generalized periodontitis.
In this study, improvement in CPITN scores seen with Dashansanskar churana and Khadiradi vati was significantly better than chlorhexidine. Neem was comparable to chlorhexidine in our study results. Dashansanskar churana is a polyherbal formulation, well known as a remedy for all types of dental problems including gingivitis. Almost all drugs of this formulation have anti-inflammatory and antibacterial properties. It also acts against the foul smell of the mouth. If used regularly for a fortnight, bleeding and pus formation are also checked. Ayurveda recommends the use of this powder for at least 3 months. In the present study, Dashansanskar churana gave the best results among all the groups and was significantly better than chlorhexidine. Less palatability to patients, especially children is the only disadvantage of this formulation which otherwise has shown promising results.
The chief ingredient of Khadiradi vati is Acacia catechu, an excellent antimicrobial and anti-inflammatory agent. It increases intracellular concentration of Vitamin C, free radical scavenging, and inhibition of collagen destruction. A clinical study using a powder of A. catechu, menthol, and camphor in the proportion of 91%, 2.7%, and 6.3%, respectively, has reported 87%–95% reduction in plaque, 70%–72% reduction in gingivitis, and 80%–95% reduction in dental calculus, in merely 15 days. Amruthesh recommended the use of Dashansanskar churana for brushing and Khadiradi vati for chewing as treatment for periodontal abscess. In our study also, Khadiradi vati gave results superior to chlorhexidine and comparable to Dashansanskar churana. With no reported side effects, it can be a good alternative to chlorhexidine in long-term use. No previous study has compared Dashansanskar churana or Khadiradi vati with chlorhexidine; hence, we could not compare our results with any other study.
Since time immemorial, Indians have used Neem (Azadirachta indica) in a variety of ways both for personal and community health by way of environmental amelioration. Neem leaf extract reduces bacteria and plaque levels that cause progression of periodontitis. In the present study, Neem gave results comparable to chlorhexidine. In a previous study by Balappanavar, the gingival response seen for Neem was better than chlorhexidine. A systematic review has also stated that Neem mouthrinse was as effective as chlorhexidine mouthrinse when used as an adjunct to toothbrushing in reducing plaque and gingival inflammation in gingivitis patients. However, the quality of reporting and evidence along with methods of studies included in this review was generally flawed with unclear risk of bias. Therefore, we state that Neem is comparable to chlorhexidine and can be used for long-term oral hygiene maintenance as there are no reported side effects of Neem mouthrinse.
Apamarga (Achyranthes aspera) root powder is extremely rewarding for cleansing teeth and preventing caries. However, it is pungent and bitter in taste, although there is no reported side effect when used as aqueous mouthwash. In the present clinical trial, Apamarga was far less effective than chlorhexidine, so much so that the control group showed better results than apamarga. Inferior results recorded in case of Apamarga root powder may be due to its bitter taste leading to patient noncompliance with oral hygiene instructions. The stem part has better activity than the root. This may be another factor affecting the activity of this powder. Our results are in sharp contrast to those seen by Bansal et al., they found that A. aspera root powder was at par with chlorhexidine in reducing plaque scores and Streptococcus mutans count in 8–12-year-old children. An in vitro study has also found A. aspera extract to be effective against S. mutans although at a higher concentration and volume than chlorhexidine gluconate. In contrast to our study, this study used powder of fresh stems and roots.
Between the four ayurvedic drugs, results of Dashansanskar churana group, Khadiradi vati group, and Neem group were comparable in our study and significantly better than Apamarga group. The duration of usage of these drugs also affected the cure rates in patients. Khadiradi vati, Neem, Dashansanskar churana, and Chlorhexidine groups showed significant improvement between 1 month and 3 month recall period. Undoubtedly, increasing the duration of treatment increased the cure rates in all the groups. These ayurvedic formulations can, thus, be used as a regular cleaning aid for maintaining the oral hygiene as their continued use in patients showed no side effects and improved oral hygiene scores.
However, there are a few limitations in this study. First, in this trial, only the outcome assessor was blinded. Participants and health-care providers were not blinded. This could have been a potential source of bias. Second, the use of drugs in trial was done by patients at home. Thus, their frequency and technique of use could not be confirmed. The difference in compliance could have led to bias in the study. Third, CPITN was used for screening of the patients as well as to assess the outcome. CPITN gives more emphasis on treatment needs rather than the disease condition. Hence, in the future studies, CPITN can be used for screening patients and an index emphasizing on the disease can be used for assessing the outcome.
| Conclusion|| |
Within the limitations of this study, it is concluded that results of three ayurvedic drugs, Dashansanskar churana, Khadiradi vati, and Neem were superior to chlorhexidine in the treatment of chronic periodontitis in human beings. Ayurvedic formularies should be used as a routine in health centers as they are effective, inexpensive, and are easily available. Use of the ayurvedic drugs should be continued for at least 3 months for achieving cure rates above 80%. Further research should be carried out on these ayurvedic drugs to strengthen the evidence in favor of their use as a standard treatment for periodontal diseases.
This research was funded by World Health Organization as GOI-WHO Collaborative Program (2010–2011) under the title “Role of Ayurvedic Drugs in Oral Hygiene, Maintenance and Treatment.”
Financial support and sponsorship
This research was funded by the World Health Organization as GOI-WHO Collaborative Program (2010–2011) under the title “Role of Ayurvedic Drugs in Oral Hygiene, Maintenance and Treatment.”
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]