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COMPLETED
NCT07672730
PHASE4

Evaluation of Topical Probiotic Gel Versus Triamcinolone in Minor Recurrent Aphthous Ulcers

Sponsor: Cairo University

View on ClinicalTrials.gov

Summary

This study looks at a new way to treat minor recurrent aphthous ulcers. These ulcers are painful, round or oval sores that show up on the soft, non-chewing surfaces of the mouth (like the inside of the cheeks or lips). While they are not dangerous, they cause severe pain and make eating, talking, and swallowing difficult. The current standard treatment is usually a topical steroid gel called triamcinolone acetonide, which helps reduce pain and swelling but can have limitations. This clinical trial is testing whether a novel topical probiotic gel can work just as well as the steroid gel to speed up healing, lower pain, and reduce local inflammation. Additionally, the study will measure a molecule found in saliva called microRNA-146a. This molecule acts as a natural biological marker that tracks how well the mouth tissue is healing from inflammation

Official title: Evaluation of Topical Probiotic Gel Versus Triamcinolone in Minor Recurrent Aphthous Ulcers: A Randomized Controlled Trial Incorporating Salivary microRNA-146a as a Novel Biomarker of Healing

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2026-02-20

Completion Date

2026-04-20

Last Updated

2026-06-29

Healthy Volunteers

No

Interventions

DRUG

Probiotic gel

Topical probiotic gel formulation designed for oral mucosal application. Participants applied a thin layer of the probiotic gel directly onto the active minor aphthous ulcer lesion four times daily. The treatment was maintained for a duration of 1 to 2 weeks depending on individual healing timelines, with clinical assessments scheduled at baseline, 1 week, and 2 weeks.

DRUG

Triamcinelone acetonide

Active control topical corticosteroid paste/gel (Triamcinolone acetonide). Participants will apply a thin layer of the triamcinolone gel directly onto the active minor aphthous ulcer lesion four times daily. The treatment will be maintained for a duration of 1 to 2 weeks, matching the experimental arm timeline, with clinical and salivary biomarker assessments scheduled at baseline, 1 week, and 2 weeks.

Locations (1)

Faculty of Dentistry (Menoufia University and Modern University for Technology and Information (MTI), Egypt).

Cairo, Egypt