A comparative study on the effect of oral bromelain capsules versus placebo on pain intensity and healing time in patients with recurrent aphthous stomatitis

Determining the impact of oral Bromelain capsules on recurrent oral ulcers

A phase 3 clinical trial with a control group, parallel groups, double-blind, randomized, involving 20 patients. Coin tossing will be used for randomization.

This study is a randomized clinical trial conducted among patients with minor recurrent aphthous ulcers who refer to the Faculty of Dentistry, Babol University of Medical Sciences. Each participant will receive oral bromelain treatment during one episode of aphthous ulceration and a placebo treatment during another episode. The study will be performed in a double-blind manner, so that neither the patients nor the dentist will be aware of whether bromelain or placebo is being administered.

Inclusion criteria:Presence of minor recurrent aphthous ulcers located on the labial or buccal mucosa, occurring at least four times per year. Exclusion criteria: Patients with a history of any systemic disease associated with oral ulcerations such as gastrointestinal disorders (Crohn’s disease, ulcerative colitis), Behçet’s syndrome, Reiter’s syndrome, hematologic diseases, malnutrition, or allergic conditions; patients with a history of receiving chemotherapy, immunosuppressive drugs, or corticosteroids within the past year; patients presenting with other oral mucosal lesions

Intervention Group: Participants in this group will receive oral bromelain capsules, two 500 mg capsules daily. Control Group: Participants in this group will receive two placebo capsules daily.

Wound size, pain, duration of recovery

The randomization of the use of oral bromelain capsules or placebo will be alternated, such that patients will be assigned a number based on their order of enrollment in the study (from 1 to 20). Patients with odd numbers (1, 3, 5, etc.) will receive oral bromelain capsules, while those with even numbers (2, 4, 6, etc.) will receive the placebo. In the second phase, the medication not received in the first phase will be administered.

Patients will not be informed about their medication (oral bromelain capsules or placebo). The placebo powder will be enclosed in capsules that are identical to the oral bromelain capsules and will be administered to the patients. Both the resident and the specialist in oral diseases will also not be provided with information regarding the type of medication consumed by the patients during the first and second examinations. An external observer (one of the residents specializing in oral diseases) will randomly assign code A or B to the placebo and the oral bromelain capsules, and the patients and researchers will be informed that they belong to group A or B; however, they will not be informed about which group is the intervention group and which is the control group. Ultimately, after the completion of the study and the interpretation of results by the statistical consultant, the external observer will disclose to which group each name belonged.