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

NCT07672730 | Completed Phase 4 DMC

• 1 other identifier: PROBIOTIC-ORAL-2026
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Treatment of Minor Aphthous Ulcers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Salivary microRNA-146a Expression Measured by qRT-PCR (ΔΔCt Method)

  Baseline, 1 week and 2 weeks after treatment initiation

Study Arms (2)

Group (1): Probiotic Gel Investigational Patient Group

EXPERIMENTAL

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

Group (2): Triamcinolone Active Control Patient Group

ACTIVE COMPARATOR

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

Interventions

Probiotic gel DRUG

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.

Group (1): Probiotic Gel Investigational Patient Group

Triamcinelone acetonide DRUG

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.

Group (2): Triamcinolone Active Control Patient Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Group1: Probiotic gel Group 2: Triamcinolone acetonide
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 29, 2026
• Study Start: February 20, 2026
• Primary Completion: April 20, 2026
• Study Completion: April 20, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)