A Randomized, Double-Blind, Placebo-Controlled Trial on Clinical Efficacy of Topical Agents in Reducing Pain and Frequency of Recurrent Aphthous Ulcers

Renu Sharma1, Shambulingappa Pallagatti2, Amit Aggarwal2, *, Soheyl Sheikh2, Ravinder Singh2, Deepak Gupta2
1 Department of Oral Medicine and Radiology, Desh Bhagat Dental College and Hospital, Mandi Gobindgarh, Punjab- 147301, India
2 Department of Oral Medicine and Radiology, Maharishi Markandeshwar College of Dental Science and Research, Mullana, Ambala, India

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© 2018 Sharma et al.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: ( This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

* Address correspondence to this author at the Department of Oral Medicine and Radiology, Maharishi Markandeshwar College of Dental Science and Research, Mullana, Ambala, India; Tel: +919896561965; E-mail:



Recurrent Aphthous Ulcers (RAU) is one of the most common oral ulcerative Disease of the oral mucosa with high recurrence rate. Standard topical treatment options provide symptomatic relief with few have been found to be effective in treating or relieving the symptoms.


The study aimed to evaluate the clinical efficacy of various topical agents in order to find the better treatment modality so as to decrease the number, size, exudate level and discomfort associated with pain with RAU.

Materials and methods:

The patients diagnosed with minor recurrent aphthous ulcers fulfilling the inclusion and exclusion criteria were enrolled. All the baseline parameters were measured by the principal investigator. The treatment modality was assigned by generating a randomization list by computer software, double-blinded in consecutively numbered sealed envelopes. The topical treatment modalities that were included: 5% Amlexanox, 0.1% Triamcinolone Acetonide, 20% Benzocaine gel, 100 mg Doxycycline hyclatemixed with denture adhesive and normal saline (20:2:1); The study was placebo controlled in which placebo gel 10 gm was used. The size, no of ulcers, pain, erythema and exudate level were measured by the principal investigator at days 1, 4, 8 and 10. All quantitative variables were estimated using measures of central tendency (mean, median) and measures of dispersion (standard deviation). Qualitative or categorical variables were described as frequencies or proportions. Proportions were compared using Post Hoc Test and N Par Tests. Effectiveness was checked using p-value (< 0.005).


It was observed that 0.1% Triamcinolone Acetonide and 5% Amlexanox proven to be more efficacious in the reduction of size, Number, Pain, Erythema and Exudate Levels at day 8, (p = .000*) and at day 10 (p =. 000*) as compared to single application of 100 mg Doxycycline Hyclate, 20% Benzocaine gel and the placebo, which was statistically significant. VAS scale was significant for 100 mg Doxycycline Hyclate and 20% Benzocaine gel.


The selected topical treatment modality can deliver cheap, effective and safe drug therapy which benefits the patient in refining their regular activities and everyday events of life.

Keywords: Recurrent aphthous ulcer, Topical treatment, Randomized, Double-blind, Oral mucosa, Placebo-controlled trial.