Assessment of the Effectiveness of Aloe vera Versus Amlexanox in the Treatment of Recurrent Aphthous Ulcers: A Three-Arm Placebo-Controlled Randomized Clinical Trial

Cureus. 2022 Oct 26;14(10):e30693. doi: 10.7759/cureus.30693. eCollection 2022 Oct.

Abstract

Background Recurrent aphthous ulcers are one of the most common lesions of the oral mucosa. Most currently available treatment methods aim to relieve symptoms, speed up healing and prevent ulcer recurrence. The current study aimed to compare the effectiveness of Aloe vera gel with that of amlexanox 5% oral paste in the treatment of recurrent small-type aphthous ulcers. Materials and Methods The study was conducted on 60 patients (27 males and 33 females) attending the Department of Oral Medicine at the Faculty of Dentistry at Damascus University. The sample age ranged between 15 to 25 years, with an average age of 20.3 ± 2.4 years. Patients were diagnosed with recurrent aphthous ulcers of the small type. The sample was divided into three groups with equal numbers of patients (n=20 for each group) according to the provided drug: Aloe vera, amlexanox, and the placebo groups. Patients' ulcer size was measured on day 0 of treatment, and the ulcer size reduction was assessed on day 3 and day 5. The pain was also recorded at the first visit, and then pain reduction was assessed during follow-up visits. Results The mean ulcer size on the fifth day of treatment was 1.85 mm2, 4.05 mm2, and 6.20 mm2 in the Aloe vera, the amlexanox, and the placebo groups, respectively. The differences between groups were significant (p=0.003). The mean pain on the fifth day was 0.80 cm, 1.60 cm, and 3.20 cm in the Aloe vera, the amlexanox, and the placebo groups, respectively. The differences between groups were significant (p=0.026). Conclusions Within the limits of the current trial, both treatment groups proved effective in accelerating ulcer healing with the superiority of Aloe vera compared to amlexanox, as it achieved a greater reduction in ulcer size and pain when assessed on the fifth day of treatment.

Keywords: aloe vera; amlexanox; effectiveness; oral mucosa; pain assessment; recurrent aphthous ulcers; treatment; ulcer healing; ulcer size.