A Comparative Study of Dexamethasone Ointment along with Triamcinolone Acetonide in Treatment of Recurrent Aphthous Stomatitis

ABSTRACT

Aim:

To assess and compare the efficacy of dexamethasone ointment with triamcinolone acetonide, the gel form, in the treatment of minor recurrent aphthous stomatitis (RAS).

Materials and Methods:

This was a randomized clinical trial of 60 patients of either sex with clinically diagnosed RAS who were randomly divided into two groups—the dexamethasone ointment group (Group I) and the triamcinolone acetonide gel group (Group II). Patients were asked to apply the gel three times a day on each ulcer. Estimation of the efficacy of gel was done based on the time required for regression in pain, size, and number of ulcers.

Results:

The results showed there was a significant difference in size, pain, number, and duration of ulcers in Group I and Group II within 7 days. However, in both groups, no significant difference was noted in the treatment of RAS.

Conclusion:

Dexamethasone ointment was found to be efficient in this treatment and was safe as evaluated using clinical assessments.

INTRODUCTION

Recurrent aphthous stomatitis (RAS) is commonly known as an aphthous ulcer, and it is the most common disease occurring in the oral cavity. The ulcers are frequently multiple, small, round, or ovoid with well-circumscribed margins having a yellow or grayish floor and surrounded by the erythematous base. It is characterized by the development of painful, recurring multiple oral ulcers in the oral cavity.

RAS is classified as:-

1. Minor RAS-They are also called “canker sores.” In this, ulcers are less than 1 cm in size. Ulcers get heal within 10–14 days without scarring.

2. Major RAS-They are also known as Sutton’s disease. In this, ulcers are more than 1 cm in diameter. The ulcers persist for up to 6 weeks and heal with scarring.

3. Herpetic form ulceration is characterized by recurrent multiple ulcers that may be up to 100 in number. Lesions are less than 0.5 cm. They are seen throughout the oral mucosa. Lesions may coalesce to form large ulcers. These ulcers last for about 10–14 days.[1]

A number of different treatments have been used so far in the RAS including steroids, analgesics, topical anesthetic agents, antiseptics, and anti-inflammatory agents.[2] The lesion is self-limited, painful, has a high frequency of occurrence, and has multifactorial etiology. Thus, well-organized therapeutic strategies are needed to provide relief to the patients.[3,4] Current treatment modalities include the use of topical steroids such as triamcinolone acetonide gel, which is a fluoride synthetic corticosteroid. Corticosteroids are known to get absorbed systemically even on topical application. These days, herbal medicines are gaining more interest due to their decreased side effects.[4-6] Triamcinolone acetonide in the gel form and dexamethasone ointment are safe and efficient in reducing ulcer size, ulcer pain, and has toning ulcer healing in patients with RAS.

MATERIALS AND METHODS

This double-blinded randomized clinical study was carried out after obtaining written informed consent from 60 patients of either sex with clinically diagnosed minor RAS visiting the Department of Oral Medicine and Radiology. Patients willing to participate in the study and with clinically diagnosed minor RAS were included in the study. Patients were excluded from the study if the ulcers were present in inaccessible areas, if they had major RAS, traumatic ulcer, denture stomatitis, or if they were suffering from systemic illness. The approval was duly taken from the Ethics Committee.

Method of collection of data-Detailed case history and extraoral and intraoral examinations were performed on the patients, and 60 patients with clinically diagnosed minor RAS were selected for the study based on inclusion and exclusion criteria. These 60 patients were randomly divided into two groups:

Group I–30 patients (dexamethasone ointment)

Group II–30 patients (triamcinolone acetonide gel)

Ulcer size was measured along its longest diameter using a sterile vernier caliper and the pain score was noted from 0–10, using the Visual Analog Scale (VAS). Patients were asked to apply the gel three times a day on each ulcer after meals and not take food or water for half an hour after the application of the gel. All patients were provided with the same measuring applicator and were instructed about the quantity and method of gel application on the first appointment itself. Patients were examined on days 0, 3, 5, and 7 to check for regression number and/or size of ulcer and any discomfort due to the gel. The pain score was noted daily by the patient.

Clinical estimation of ulcer

The response to treatment was assessed by quantitative measurement of the diameter of the ulcer using a vernier caliper at each follow-up visit by a single observer. The patients were instructed to note the pain score every morning on his/her record card as per the VAS. Assessment of the efficacy of gel was done based on the time required for regression in pain, size, and number of ulcers.

Details of dexamethasone ointment

• Dexamethasone ointment (Abbott Pharmaceuticals).

Details of triamcinolone acetonide gel:

• Kenacort oral paste (Abbott Pharmaceuticals).

• The gel contains 0.1% triamcinolone acetonide.

Data are presented as mean ± standard deviation (SD) for quantitative variables with normal distribution and the significance of difference was accepted at P < 0.05. Background and demographic data are summarized with descriptive statistics. To evaluate the efficacy, Mann–Whitney U test was used and statistical analysis was done using the Statistical Package for the Social Sciences (SPSS) 18 software. 270

RESULTS

A total of 60 patients participated in the study and all patients completed the study protocol. No significant difference was identified between patients randomly assigned to Group I or Group II with regard to basic demographic data, including age and gender, size of ulcers, and pain score on day 0. The reduction in pain was statistically significant in both the groups from day 0 to day 7; however, in a comparison between Group I and Group II, no statistical significance was noted in the pain score.

The reduction in size and the number of ulcers were statistically significant in both the groups from day 0 to day 7 (noted on days 0, 3, 5, 7); however, on comparison between Group I and Group II, no statistical significance was noted in the size and number of ulcers. There was statistical significance in the duration of ulcers in both the groups from day 0 to day 7; however, in comparison between Group I and Group II, no statistical significance was noted in the duration of ulcers [Table l].

Table 1.

Comparison of pain score between Group 1 and Group 2

Pain score	Group 1		Group 2		Z #	P #
	Mean	±SD	Mean	±SD
Pre-application	7.33	0.802	7.27	0.828	0.334	0.738; NS
Post-application Day 4	4.77	1.073	4.93	1.048	0.848	0.396; NS
Post-application Day 7	0.43	0.679	0.53	0.776	0.494	0.621; NS
Change on day 4	2.57	0.568	2.33	0.479	1.626	0.104; NS
Percentage change on day 4	35.57	9.259	32.725	8.839	1.064	0.287; NS
Change at Day 7	6.90	0.548	6.73	0.521	1.169	0.242; NS
Percentage change at Day 7	94.709	8.125	93.446	9.179	0.543	0.587; NS

Mann-Whitney test: NS: P>0.05; not significant.

DISCUSSION

Triamcinolone acetonide is a synthetic glucocorticosteroid with immunosuppressive and anti-inflammatory activity. Triamcinolone acetonide binds to specific cytosolic glucocorticoid receptors and subsequently interacts with glucocorticoid receptor response elements on DNA and alters gene expression. This results in an induction of the synthesis of certain anti-inflammatory proteins while inhibiting the synthesis of certain inflammatory mediators. Consequently, an overall reduction in chronic inflammation and autoimmune reactions is accomplished.

Dexamethasone is a fluorinated glucocorticosteroid and acts as an adrenergic agent, an antiemetic, an antineoplastic agent, an environmental contaminant, a xenobiotic, an immunosuppressive agent, and an anti-inflammatory drug. Dexamethasone is a synthetic adrenal corticosteroid with potent anti-inflammatory properties. In addition to binding to specific nuclear steroid receptors, dexamethasone also interferes with NF-kB activation and apoptotic pathway.

Topical glucocorticosteroids are the most widely used drugs in the treatment of immune-mediated oral mucosal disease. In patients with RAS, the indicated medicaments are triamcinolone acetonide and other corticosteroids also. The lesions are minor and localized in nature, the best form of application of the drug is gel 0.1%. Another ranseform is a concentrate form 0.05 to 0.5% applied 3–5 times a day for 3–5 min. It is indicated in patients with small and mild erosive lesions. Some authors consider 0.1% to be an effective concentration. To facilitate healing, the most advisable form is gel directly applied to the lesion.

Dexamethasone is also used to treat inflammatory lesions such as chronic ulcers, gingival ulcers, and erosive stomatitis. It alleviates inflammation by suppressing polymorphonuclear leukocyte migration and reducing capillary permeability. A randomized controlled study conducted by including 30 adult patients indicated that dexamethasone was safe and effective, and significant decreases in ulcer size and pain scores on day 7 post-therapy were observed, without adverse effects. In the present study, dexamethasone ointment 0.05% showed a significant result in the treatment of RAS.

Although the risks associated with corticosteroid use can be mitigated by limiting the treatment duration, corticosteroids are contraindicated in certain patients. It provides a faster healing effect along with lowering the ulceration stage, associated with a lower risk of complications, discomfort, and drug interactions. There is no overdose risk with topical corticosteroids.

Although the outcomes of this study are encouraging, there were some limitations. First, the study used a retrospective, single-center design and included a very limited patient population. Lack of follow-up may have introduced selection and information biases. Future studies with a larger number of patients should address the above limitations and compare RAS treatment protocols based on antibiotics, corticosteroids, and other anti-inflammatory drugs.

Dexamethasone is an efficient and safe topical corticosteroid in the treatment of RAS. Treatment of RAS provides symptomatic relief to the patient, and the goals of treatment include reduction in healing time of ulcer, size, reduced pain, and the number of ulcers.[4-6] Current treatment modalities include the use of systemic and topical steroids, cauterization, antibiotics, mouth rinses containing active enzymes, laser treatments, and combination therapy.[7]

We all know, RAS is the most common chronic disease of the oral cavity, affecting 5–25% of the population.[8] RAS is a kind of lesion in the oral mucosa consisting of the sudden and painful acute loss of the normal tissue in the mucosa, it is very disabling and recurrent and its specific cause is unknown.[9] As is known for its strong antioxidant, antiseptic, antibacterial, anti-inflammatory, immune-modulatory, and analgesic properties, the study was carried out to evaluate the therapeutic effect of dexamethasone ointment. Patients with RAS showed a good percentage of complete healing.

This study showed that there was a significant difference between the pain score, size, number, and duration of ulcers. Statistical significance was not noted between all the parameters when both the groups were compared with each other. Dexamethasone ointment can be used as an effective and safer alternative to steroids in the treatment of minor RAS.

CONCLUSION

Dexamethasone ointment was efficient in the treatment of RAS and was safe as evaluated using clinical assessment.[10] The topical application of dexamethasone ointment and triamcinolone acetonide gel showed similar efficiency in the treatment of minor RAS.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.