|Year : 2021 | Volume
| Issue : 1 | Page : 53-59
Correlation of pain score with ulcer size in oral aphthous ulcers using 2% curcumin gel and 0.1% triamcinolone oral paste - A parallel comparison study
Praveena Raman1, H Raghuram Pitty2
1 Department of Oral Medicine and Radiology, Sathyabama Dental College and Hospital, Chennai, Tamil Nadu, India
2 Department of Oral Medicine and Radiology, SRM Dental College and Hospital, Chennai, Tamil Nadu, India
|Date of Submission||08-Aug-2020|
|Date of Decision||13-Jan-2021|
|Date of Acceptance||14-Jan-2021|
|Date of Web Publication||26-Mar-2021|
Dr. Praveena Raman
Lemon Dental, #4/3, Krishna Street, Vivekananda Nagar, Nesapakkam, K. K. Nagar West, Chennai - 78, Tamil Nadu
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: Recurrent aphthous stomatitis (RAS) is a common inflammatory condition affecting the oral mucosa causing interference with mastication and speech with significant impact on quality of life. The use of topical steroids remains the mainstay as the primary therapeutic approach and they are often considered to be the first choice of treatment. Turmeric has been used in the Indian traditional medicine for centuries. Its anti-inflammatory and wound healing activities are demonstrated by the rapid healing of the ulcers. Aim: The primary aim of this study was to assess and correlate pain score with ulcer size using topical curcumin 2% gel and triamcinolone acetonide oral paste 0.12% in recurrent minor oral aphthous ulcerations. Methodology: Following convenient sampling, 60 volunteered students with oral aphthous ulcers were included to take part in this single-blinded randomised study. Randomization was done by flip coin method. Group I received Topical Curcumin oral gel 2% and Group II received Topical Triamcinolone acetonide 0.1%. Statistical Analysis: Qualitative data was expressed in percentage and quantitative in mean (SD). Independent sample t test and correlation was done. Results: The ulcer size was smaller initially and gradually increased in the next few days and the size decreased upon ulcer healing. Initially, the pain score was higher and gradually decreased as the ulcer healed. Positive correlation of ulcer size and pain score was obtained in Group I on the 1st day, 4th day and 5th day with statistical significance of P < 0.001 and negative correlation on 2nd day without statistical significance. Ulcer size and pain score in Group II was correlated negatively on Day 1, 2, 6 and 7 without statistical significance and positively correlated from Day 3-5 without statistical significance. Ulcer size and pain score was negatively correlated with statistical significance for Day 6 and 7. Conclusion: Our study showed that Curcumin performed on par with triamcinolone and there is no positive correlation between ulcer size and pain score with topical management of Curcumin and Triamcinolone in aphthous ulcers. Though both the drug was effectively able to bring down the pain and size without any side effects, with a borderline favorable result with steroid.
Keywords: Aphthous ulcers, correlation, curcumin, recurrent aphthous stomatitis, triamcinolone, ulcer pain, ulcer size
|How to cite this article:|
Raman P, Pitty H R. Correlation of pain score with ulcer size in oral aphthous ulcers using 2% curcumin gel and 0.1% triamcinolone oral paste - A parallel comparison study. J Indian Acad Oral Med Radiol 2021;33:53-9
|How to cite this URL:|
Raman P, Pitty H R. Correlation of pain score with ulcer size in oral aphthous ulcers using 2% curcumin gel and 0.1% triamcinolone oral paste - A parallel comparison study. J Indian Acad Oral Med Radiol [serial online] 2021 [cited 2021 Apr 14];33:53-9. Available from: https://www.jiaomr.in/text.asp?2021/33/1/53/312199
| Introduction|| |
Recurrent aphthous stomatitis (RAS), commonly known as Canker sores, is one of the most common oral mucosal lesions. The prevalence of RAS in India (2010–2012) is 21.7%., It is an acute painful condition confined to the nonkeratinized oral mucosa. Topical corticosteroids are the most widely used, evidence-based groups of drugs to combat aphthous ulcers; however, they are associated with some side effects. The Indian system of holistic medicine known as Ayurveda uses mainly plant-based drugs or formulations to treat various ailments including cancer. Curcumin is a powerful antioxidant and it is extensively investigated in the management of multiple oral mucosal lesions and conditions. There are many clinical trials with Curcumin and Triamcinolone acetonide focussing on symptomatic reduction, recurrence reduction and pace of healing in oral aphthous ulcer. However till date, there is no data regarding the correlation of pain score and ulcer size in RAS using topical curcumin and triamcinolone acetonide.
| Aim|| |
To correlate the pain score with ulcer size in recurrent oral aphthous ulcerations (OAU) on application of topical Curcumin gel and Triamcinolone acetonide oral paste.
| Objectives|| |
- To assess the reduction in ulcer size and pain score using topical Curcumin.
- To assess the reduction in ulcer size and pain score using topical Triamcinolone acetonide
- To correlate the ulcer size and pain score in topical Curcumin and topical Triamcinolone group, and
- To correlate the overall ulcer size and pain score.
To evaluate the efficacy of topical Curcumin and topical Triamcinolone acetonide in recurrent oral aphthous ulcerations.
| Methodology|| |
This single centre drug trial was carried out at Department of Oral Medicine and Radiology, of a dental college in Chennai, Tamil Nadu and was approved by the Institutional Ethical and Scientific Committee Board (SRMU/M&HS/SRMDC/2013/902). The procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional or regional) and with the Helsinki Declaration of 1975 that was revised in 2000. Informed consent was obtained from all the willing participants.
This is a single centre, interventional, parallel comparison, follow up study. Sample size was determined by considering a confidence level of 95% and an error rate of ±5%, determining the need to include 60 participants in the study. Convenient sampling/opportunity sampling was used as part of non-probability sampling. 60 volunteered students with oral aphthous ulcers were included to take part in this single-blinded randomized clinical trial. Randomization was done by flip coin method. Group I received Topical Curcumin oral gel 2% and Group II received Topical Triamcinolone acetonide 0.1%.
- Students with recurrent, painful, single/multiple oral aphthous ulcers measuring less than 1 cm
- Undergraduates, postgraduates and research scholars of the study institution only
- Students reporting on day 1 were only included (to ensure continuous assessment of ulcer size and pain score to meet our primary objective to correlate them).
- Out-patients were excluded, due to difficulty in daily monitoring until the ulcer heals
- Students who are not willing
- Students under any systemic or topical corticosteroid therapy
- Pregnant and lactating professionals
- Students undergoing orthodontic treatments
- Students who are allergic to medications, certain food and additive colours.
Detailed case history, extraoral, and intraoral examination was performed on 60 students who volunteered to take part in this single-blinded clinical trial. Participants were selected for the study based on the above-mentioned inclusion and exclusion criteria. Clinical confirmation of minor aphthous ulcers was done by 2 oral medicine experts from the department of Oral Medicine and Radiology. All participants were subjected to routine blood investigations to rule out blood dyscrasias and chronic anaemia. Topical Curcumin ('Curenext': Curcuma longa 10 mg oral gel 2%) and topical Triamcinolone acetonide- 'Kenacort': triamcinolone acetonide oral paste 0.1% were dispensed to each student in group I and group II, respectively, in an identically packed container by the study investigator. No participant was aware of the drug they received. As a parallel comparison study, each subject was followed up for 6 months. Baseline pain score and ulcer size were noted by the study investigator on Day 1. Ulcer size was measured using a Williams periodontal probe. Initially, students were instructed to note down their pain score (mild, moderate or severe) in morning, at lunchtime and at bedtime. Each day ulcer size was measured in the department and the pain score was assessed using the visual analog scale and compiled data was subjected to statistical analysis.
All statistical analysis was performed using the SPSS (Statistical Package for the Social Sciences) software version 22.0 and the significant level was accepted with P value < 0.05. Qualitative data was expressed in Percentage and Quantitative in mean (SD). Independent sample t test was carried out to compare the means. Correlation was performed for ulcer size and pain score individually and in both the groups.
| Results|| |
In this study, the age of the patients ranged from 18-30 yrs in both the groups and the mean age in Group I and Group II was 21.3 years and 21.6 years respectively. 36.7% and 26.7% constituted males in Group I and Group II respectively and 63.3% and 73.3% constituted females in Group I and Group II respectively. Female predominance was observed in both the groups. The predominant site of ulcer occurrence was lower labial mucosa followed by upper labial mucosa and ventral surface of tongue. The ulcer size was smaller and gradually increased in the next few days and the size decreased upon ulcer healing as shown in [Graph 1]. The mean ulcer size was statistically significant from Day 2-5 in both the groups with a lower mean value in Group B while compared to Group A, inferring that Drug B is able to reduce the ulcer size earlier than Drug A. Subjects in both Group A and Group B had a gradual reduction in their pain scores from 1st day till the ulcer heals as plotted in [Graph 2]. Statistically significant difference was observed from Day 1-5 as shown in [Table 1] with a lower mean value in Group B inferring that both Drug A and Drug B are able to bring down the pain scores but Drug B is able to reduce pain faster than Drug A. [Table 2], [Table 3], [Table 4] show the correlation of ulcer size and pain score in Group A, B and overall. [Graph 3] plots the mean pain score with size of ulcer in both Group A and B.
|Table 1: Independent samples t-Test to compare mean values between Group A and Group B|
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|Table 4: Overall correlation in both Group A and Group B with ulcer size and morning pain|
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[Table 2] shows a positive correlation between ulcer size and pain in 1st day, 4th day and 5th day with statistical significance of P < 0.001 and negative correlation on 2nd day without statistical significance inferring that when the ulcer size is smaller in the Curcumin group, the pain is also minimal. Ulcer size and pain score in Group I is positively correlated on Day 1-3 with statistical significance only for Day 1 and ulcer size and pain score is negatively correlated from Day 4-7 without statistical significance as explained in [Table 2]. Ulcer size and pain score in Group II is negatively correlated on Day 1, 2, 6 and 7 without statistical significance and positively correlated from Day 3-5 without statistical significance as explained in [Table 3]. On overall correlation in both the groups, ulcer size and pain score were positively correlated from Day 1-5 with statistical significance from Day 1-5. Ulcer size and pain score was negatively correlated with statistical significance for Day 6 and 7 as explained in [Table 4]. Inferring that, there is no correlation between ulcer size and pain score with individual drugs and when pain scores and ulcer size are combined together from both the groups, there exists a statistical significance with P < 0.001.
Group A shows treatment with Curcumin and Group B shows treatment with Triamcinolone acetonide Group A. [Figure 1] (a) and [Figure 2] (a) and [Figure 1] (b) and [Figure 2] (b) shows pretreatment images and post treatment images respectively. Group B [Figure 1] (a) and [Figure 2] (a) and [Figure 1] (b) and [Figure 2] (b) shows pretreatment images and post treatment images respectively.
|Group A Figure 1: a. Pre-treatment with Curcumin b. Post treatment with Curcumin. Figure 2: a. Pre-treatment with Curcumin b. Post treatment with Curcumin|
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|Group B Figure 1: a. Pre-treatment with Triamcinolone acetonide b. Post treatment with Triamcinolone acetonide. Figure 2: a. Pre-treatment with Triamcinolone acetonide b. Post treatment with Triamcinolone acetonide|
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| Discussion|| |
The multifactorial aetiology of RAS and lack of effective treatment modality makes it a challenge for the dentist to relieve the patient from the morbidity associated with RAS. As the treatment of RAS aims at providing symptomatic relief for the patient, the goals of treatment include to decrease pain, size and reduction in healing time of ulcer., To our knowledge this is the first study conducted in a parallel design for 6 months with a primary aim to correlate ulcer size and pain score in RAS by evaluating efficacy of topical Curcumin gel and Triamcinolone acetonide oral paste. In this context, this study is an important addition to the existing literature. The incidence rate of RAS is higher in students, higher socioeconomic classes, female, and age in the range of 10 to 40 years. Clinically, RAS is classified into 3 types:
- Minor RAS (also known as Miculiz's aphthae). Ulcers are usually less than 1 cm in size. Ulcers heal within 10–14 days without scarring.
- Major RAS (also known as periadenitis mucosa necrotica recurrens or Sutton's disease). Ulcers exceed 1 cm in diameter. The ulcers persist for up to 6 weeks and heal with scarring.
- Herpetiform ulceration is characterized by recurrent crops of multiple ulcers; may be up to 100 in number. These are small in size, measuring 2-3 mm in diameter. Lesions may coalesce to form large irregular ulcers. These ulcers last for about 10-14 days. (2,4)
In our study, female predominance was observed in both the groups which is in accordance with the studies conducted by Nolan et al., Malayil et al. and Abdullah et al.,, Size and pain of the ulcer gradually reduced as healing occurred which is in accordance to the study conducted by Halim. The study conducted by Altaei et al. found that tongue was the most common site for ulcers in female which is contrast to our finding, where labial mucosa is the most common site of RAS. Halim et al. conducted a similar drug trial with curcumin and triamcinolone and found that there is no significant difference between ulcer healing in both the drugs which is not in accordance to our study. Our study showed a borderline favourable result with triamcinolone and we had compared the ulcer size and pain score, which is first of its kind in the literature. Manifer. S et al. conducted a randomised placebo trial using curcumin gel in 29 minor aphthous ulcer patients and was able to substantiate that Curcumin gel could significantly reduce pain and ulcer size than placebo in 2 weeks which is in line with our drug trial. Raman et al. compared the efficacy of curcumin and triamcinolone by assessing six clinical variables and used Kaplan Meir survival analysis to statistically validate pain reduction and ulcer healing and found similar results as in our study. Our study showed positive and negative correlation between initial ulcer size and pain in Group I and II respectively which cannot be compared with any other available data as ours is the first study to correlate ulcer size and pain score. On overall correlation in both the groups, ulcer size and pain score were positively correlated from Day 1-5 with statistical significance from Days 1 to 5 and ulcer size and pain score was negatively correlated with statistical significance for Days 6 and 7, inferring that, there is no correlation between ulcer size and pain score with individual drug and when pain scores and ulcer size are combined together from both the groups, there exists a statistical significance with P < 0.001.
Our study also showed satisfactory healing of OAU with topical Curcumin gel 2%. All the participants were in good general health with no significant abnormalities before, during or after the study. There were no major adverse effects reported in both the groups during the study period.
Limitations and future prospects
Firstly, sample size of the study, it was compromised due to involvement of students from the study institution. However, out-patients were not preferred due to difficulty in monitoring for ulcer size and pain scores. Secondly, the heterogeneous nature of the study group, few participants were not native to the same place where the study was conducted. Thirdly, participants could have missed application of drugs which can lead to variations in study results. However, a larger sample with comparison with other drugs and with immunological markers including other clinical parameters can surely prove the efficacy of our herbal boon Curcumin in oral ulcers.
| Conclusion|| |
Our study showed that Curcumin was performing on par with triamcinolone and there is no positive correlation between ulcer size and pain score with topical management of Curcumin and Triamcinolone in aphthous ulcers; however, both the drugs were effectively able to bring down the pain and size without any side effects. Also, topical Curcumin is safe, easily available, and economical and can be routinely recommended by an oral physician to obtain pain relief in oral aphthous ulcers.
The author would like to remember and thank all the study participants for their cooperation in the study; Dr P Venkatesan and Mr Boopathi for their valuable statistical assessments, analysis and counselling in arriving at the study results; Dr. K. Raman and family, Mr Karthikeya Murthy, and Mrs and Mr Jagannathan for their constant support and ever-willingness to guide in the successful completion of the study and manuscript writing.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4]