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

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

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

Study Overview

• Status: Completed
• Conditions: Treatment of Minor Aphthous Ulcers
• Intervention / Treatment: Drug: Probiotic gel; Drug: Triamcinelone acetonide

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Both genders
• Adults ≥18 years diagnosed with minor recurrent aphthous ulcer based on clinical examination (Parra-Moreno et al., 2023).
• The definitive diagnostic criteria for Minor Recurrent Aphthous Ulcers (Minor RAU/RAS) rely heavily on distinct clinical features and standard medical histories. Because there is no single definitive lab test or histopathological standard, diagnosis is made primarily by clinical evaluation (Baccaglini et al., 2013; Akintoye and Greenberg, 2014)

Exclusion Criteria:

• Patients with major aphthous ulcer or traumatic ulcers, patients took steroids in last 6 months, vulnerable groups as prisoners, mentally disabled, pregnant orlactating women (El-Haddad et al., 2014).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group (1): Probiotic Gel Investigational Patient Group; A topical probiotic gel formulation designed for direct oral mucosal application. Participants will apply a thin layer of the experimental probiotic gel directly onto their minor recurrent aphthous ulcer lesion(s) four times daily. The therapeutic regimen will be maintained continuously for a duration of 1 to 2 weeks. Clinical assessments (lesion size; pain intensity via Visual Analogue Scale; and Thongprasom scoring) and salivary microRNA-146a biomarker collections will be systematically performed at baseline, 1 week, and 2 weeks.	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.
Active Comparator: Group (2): Triamcinolone Active Control Patient Group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minor Recurrent Aphthous Ulcer Size (mm) Measured Using Periodontal Probe	The size of the target minor recurrent aphthous ulcer will be measured clinically in millimeters using a calibrated periodontal probe. The maximum ulcer diameter will be recorded at baseline, 1 week, and 2 weeks after treatment initiation. Change in ulcer size from baseline will be calculated. A reduction in size indicates clinical improvement and healing.	Baseline, 1 week, and 2 weeks after treatment initiation
Pain Severity Measured Using Visual Analogue Scale (VAS 0-10)	Pain severity related to the target aphthous ulcer will be assessed using a 0-10 Visual Analogue Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded at baseline, 1 week, and 2 weeks after treatment initiation. Change from baseline will be compared between the probiotic gel group and the triamcinolone group. A lower score indicates improvement.	Baseline, 1 week, and 2 weeks after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary microRNA-146a Expression Measured by qRT-PCR (ΔΔCt Method)	Salivary microRNA-146a expression will be assessed from saliva samples using RNA extraction, reverse transcription, and real-time quantitative PCR. Relative expression will be calculated using the ΔCt and 2-ΔΔCt methods. Expression levels will be compared between baseline and post-treatment values to assess molecular changes related to inflammation and healing.	Baseline, 1 week and 2 weeks after treatment initiation

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2026
• Primary Completion (Actual): April 20, 2026
• Study Completion (Actual): April 20, 2026

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PROBIOTIC-ORAL-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No