Comparative Evaluation of Efficacy of Jati Ghrita and 1% Chlorhexidine Gluconate on Aphthous Stomatitis- A Research Protocol for Randomised Control Trial
Correspondence Address :
Intern, Department of Public Health Dentistry, Sharad Pawar Dental College and Hospital, DMIMS (Deemed To Be University), Sawangi (Meghe), Wardha-442001, Maharashtra, India.
Introduction: Aphthous ulcer is seen to be one of the most commonly occurring ailments found among patients that dentists may come across on a daily basis. Taking into consideration, the agents that have been used for treatment of Aphthous stomatitis safety, least toxic properties with symptomatic relief and topical application are considered. These days there are few reliable natural remedies which are emerging as a therapy for aphthae. Herbal and polyherbal medicines will alleviate pain, induce healing, prevent infection and lessen inflammation in aphthous ulcers without any adverse effects.
Aim: To evaluate and compare the efficacy of Jati Ghrita and 1% chlorhexidine gluconate on aphthous stomatitis patients.
Materials and Methods: A randomised control trial will be carried out for an expected time of 3-4 months, in the Department of Oral Medicine and Radiology, Sharad Pawar Dental College and Dattatray Ayurvedic Rasashala, Wardha, Maharashtra, India. The study population consisting of 30 patients (age 18-65 years) with Aphthous stomatitis will be divided randomly into two groups i.e., Jati Ghrita and 1% Chlorhexidine gluconate, each group consisting of 15 patients. Efficacy will be assessed by patient’s response through Visual Analogue Scale (VAS) and oral physician’s observation-5 point Investigator’s Global Assessment (IGA) scale. The intergroup comparison will be done by independent sample t-test.
Expected Results: Jati Ghrita is expected to be effective in faster healing of aphthous stomatitis with reduction in pain. Jati is also expected to be more effective than 1% chlorhexidine gluconate.
Conclusion: Hence, this study will evaluate and compare the efficacy of Jati Ghrita and 1% chlorhexidine gluconate on aphthous stomatitis.
Inflammation, Recurrence, Ulcers, Triamcinolone
Aphthous stomatitis is one of the most frequently occurring oral mucosal conditions whose cause remains elusive. It is characterised by recurrent and painful ulcerations which may be of round or ovoid shape with varying diameter and circumscribed by margins and erythematous haloes in between. It is valuated to affect almost 5% to 50% of the population considering any age group. Suitable management of patients with aphthous stomatitis is largely symptomatic and should be directed on lessening ulcer duration, alleviating pain and decreasing or preventing ulcer recurrence. Treatment seeks to relieve pain and diminish functional disabilities, inhibit the acute inflammatory response, and minimise the frequency and severity of recursions (1). Those drugs that are used to treat Recurrent Aphthous Stomatitis (RAS), it seems advisable to use the least toxic and safest medication that provides relief and can be applied topically (2).
These days, there are few reliable natural remedies which are emerging as a therapy for aphthae. Herbal and polyherbal medicines will alleviate pain, induce healing, prevent infection and lessen inflammation in aphthous ulcers without any adverse effects. According to World Health Organisation (WHO) (1993) almost 80% of the world’s inhabitants is reliant on conventional medicine and a main division of traditional treatments include the use of plant extracts or their active elements (3). Jati is one of such herbal modalities gaining attention for its versatile medicinal properties.
Jati (Jasminum officinale) has a number of traditional uses, including treating odontalgia, mobile teeth, ulcerative stomatitis, skin disorders, otorrhoea, hearing disorder, dysmenorrhoea, ulcers, wounds, ringworm, and corns (4). Jati extract along with ghee accelerates wound healing (5). As per mentioned in ayurveda, ghee facilitates percutaneous absorption of substances. Ghee being more lipophilic and after processing, lubricating ghee helps for better diffusion and percutaneous absorption of drugs and other substances which are topically applied (6).
Topical treatment modalities that are frequently used, includes topical glucocorticosteroids, local analgesics, antibiotic and astringents. Chlorhexidine gluconate gel 1.0% (Hexigel) is used to treat aphthous stomatitis (7). Previous literature has been reported to study the effects of curcumin and honey on Aphthous Stomatitis patients (8). But no study has been done till now for comparative evaluation of efficacy of Jati Ghrita and 1% chlorhexidine gluconate on Aphthous Stomatitis. Hence, to determine clinically the effectiveness and safety of Jati Ghrita on recurrent aphthous stomatitis, a comparative study will be conducted versus chlorhexidine gluconate gel (1.0%) to supervise the symptoms related to aphthous ulcers with a randomised control trial. Hence the study is planned RCT to evaluate and compare the efficacy of Jati Ghrita and 1% chlorhexidine gluconate on aphthous stomatitis patients.
A randomised control trial, approved by the Institutional Ethical Committee (ref. no.: DMIMS(DU)/IEC/2022/1173) will be held in the Department of Oral Medicine and Radiology, Sharad Pawar Dental College and Dattatray Ayurvedic Rasashala, Mahatma Gandhi Ayurved College and Research Center, Salod, a constituent college of Datta Meghe Institute of Medical Sciences (Deemed University) Wardha Hospital and Central Research Laboratory Jawaharlal Nehru Medical College and Hospital, Wardha, Maharashtra, India on patients with recurrent aphthous stomatitis for an expected time period of 3-4 months. An informed written consent will be received from all the patients in addition with the explanation of the procedure to be performed. Only those patients who are ready to take part in the study will be considered.
Inclusion criteria: This study will include male and female patients, age between 18-65 years presenting with aphthous ulcers of less than 48 hours duration.
Exclusion criteria: Patients who are undergoing any treatment or therapy for aphthous ulcers, individuals with any known systemic disorders, pregnant and lactating women, and clinical conditions including serious kidney, liver and heart dysfunction will be excluded from the study.
Sample size calculation: with the help of formula given below:
n=(Z1-α/2+Z1-β)2 p1(1-p1)+p2 (1-p2)
Proportion of outcome (p1)=0.80, Proportion of outcome (p2)=0.65 (8), Level of significance (α)=0.05, Power (1-β)=0.80, Z alpha value=1.96, Z beta value=0.84, =(1.96+0.84)2 0.80(1-0.80)+0.65(1-0.65), (0.80-0.65)2, Attrition=20%, Total Sample size=30
A study population comprising of 30 patients that will be segregated randomly into two groups i.e., Jati Ghrita and 1% chlorhexidine gluconate, each group consisting of 15 patients. The period required to treat will be 5 days during which group A will be given Jati Ghrita and group B will be given 1% chlorhexidine gluconate, both to be applied topically by themselves twice a day.
Jati Ghrita will be prepared in Dattatray Ayurvedic Rasashala, Mahatma Gandhi Ayurved College and Research Center, Salod, a constituent college of Datta Meghe Institute of Medical Sciences (Deemed University) Wardha. Composition for 10gm- Jati patra swaras- 40ml, Jati patra kalk- 2.5gm and Goghrita 10gm (9).
Efficacy will be assessed by patient’s response-Visual Analogue Scale (VAS) and oral physician’s observation-5 point Investigator’s Global Assessment (IGA) scale (10). Hayes and Patterson in 1921 used the first pain rating scale as VAS. Scale is based on the scores which shows measures of symptoms that are reported by the patients that are taken down with a single handwritten mark assigned at a point alongside the length of a 10-cm line that denotes two ends of the scale i.e., “no pain” on the left extremity i.e., 0 cm of the scale and the “worst pain” on the right extremity of the scale i.e., 10 cm (10). IGAs denote the complete estimation of disease severity, which is comparatively simple to complete and evaluate clinical signs at once (11).
Bias: All the potential sources of bias has been eliminated.
Analysis of the collected data will be done by Statistical Package for Social Sciences (SPSS) version 22.0. The inter-group comparison will be done by independent sample t-test and descriptive statistics will be applied for mean and standard deviation of the variables. The significance level will be set at p-value<0.05.
Expected Outcomes /Results
Jati Ghrita is expected to be effective in faster healing of aphthous stomatitis with reduction in pain. Jati is also expected to be more effective than 1% chlorhexidine gluconate.
Miles DA et al., conducted a study in the year 1993 in which they analysed effectiveness of pain control of Chlorhexidine compared with Triamcinolone acetonide used to treat aphthous stomatitis. Their study involved 30 patients affected with aphthous ulceration. They were segregated randomly into three groups, one of these was a control group. The remaining were experimental groups that were topically given either triamcinolone acetonide or chlorhexidine digluconate. Patients were instructed to note their pain tolerance level on a ten centimetre VAS till the ulcer was completely healed. Based on the results, the authors concluded that there are high levels of significant differences in pain severity and perception during different days, and chlorhexidine reduces pain similarly to triamcinolone. Consequently, there was no remarkable difference found between chlorhexidine gluconate and triamcinolone acetonide (12).
In an experimental study conducted by Dhulappa M and Ashok W, in the year in 2013 on Jasminum grandiflorum, referred to its Vrana Ropana i.e., wound healing activity, evaluated the effectiveness of extract and kalka (paste) on excision wound model. The paste was obtained from leaf of Jati. The study involved healthy albino rats, which was carried out for twenty one days. Rats were segregated into three groups with each containing six. Extract and kalka were the two groups for the trial drug, one was a control group i.e., betadine ointment. Wound area was measured once by using graph in every four days and the data were analysed. Authors concluded that contraction of wound and epithelisation was enhanced by extract of Jati and paste of leaf i.e., kalka and its application showed equal effect with control group, therefore, in treatment of excised wound, jati extract and the paste of leaf is considered to be safer, efficacious and well tolerated (13).
Sathish HS et al., evaluated wound healing potential of medicated ghee. In their study, they have formulated the drug named as Jati Kalpa Ghrita which was derived from the combination of drugs having wound healing properties. Their study involved 110 patients divided into two groups A and B with 75 and 35 patients, respectively. They found that there was highly significant wound contraction with trial drug when compared to control group. Authors concluded that Jati Kalpa Ghrita is highly efficacious in healing of Shuddha Vrana and proves to be a potent drug for wound healing (14).
In the year 2019, Mangtani KN et al., conducted a study on the antibacterial activity of leaf extracts of Jasminum officinale against oral pathogens in ulcer treatment. In their study, the antibacterial activity has been studied against S.aureus, Escherichia coli, Pseudomonas aeruginosa, Bacillus subtilis and Enterococcus faecalis using an agar well diffusion method. They concluded that extract of Jasminum officinale leaves gives effective results against oral pathogens causing mouth ulcer and therefore, the authors can use natural medicines in place of antibiotics in future (15).
Aphthous stomatitis is frequently occurring oral mucosal condition of undetermined etiopathogenesis for which symptomatic therapy only is available. As a result, treatments are limited to suppressing symptoms rather than addressing susceptibility and prevention. Jati ghrita is composed of Jati leaves extract and ghee. As Jati has good medicinal properties and ghee accelerates wound healing, so combination of this will be effective for treating aphthous ulcers.
Date of Submission: May 10, 2022
Date of Peer Review: Jun 07, 2022
Date of Acceptance: Nov 21, 2022
Date of Publishing: Mar 01, 2023
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. NA
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