Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Recurrent Aphthous Stomatitis

Phase 2

Not yet recruiting

• Conditions: Recurrent Aphthous Stomatitis
• Interventions: Drug: 0.1% Topical Triamcinolone Acetonide in Orabase; Dietary Supplement: 35% Topical Bromelain in Orabase; Dietary Supplement: 50% Topical Bromelain in Orabase

• Registration Number: NCT06993337
• Lead Sponsor: Cairo University

Brief Summary

Bromelain, a natural product, exhibits anti-inflammatory, immunomodulatory, and wound-healing properties. However, its efficacy in treating oral mucosal ulcers remains unexplored. This study aims to evaluate the effect of bromelain as a safe alternate for management of RAS.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-25
• Last Update Submitted: 2025-05-25
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28
• Study Start: 2025-06-15
• Primary Completion: 2026-05-15
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Adults aged 18-60 years.
• Diagnosed with RAS.
• Onset of ulcer within the last 48 hours.
• Willingness to participate and provide informed consent.

Exclusion Criteria

• History of hematological deficiencies, GIT disorders, Behcet's disease and major systemic diseases.
• Pregnant or breastfeeding patients.
• Previous treatment for the current ulcer episode.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.1% Topical Triamcinolone Acetonide in Orabase	0.1% Topical Triamcinolone Acetonide in Orabase	This group will receive the standard treatment of 0.1% triamcinolone acetonide in orabase, commonly used for managing Recurrent Aphthous Stomatitis.
35% Topical Bromelain in Orabase	35% Topical Bromelain in Orabase	Participants in this group will receive 35% bromelain gel incorporated into an orabase adhesive medium.
50% Topical Bromelain in Orabase	50% Topical Bromelain in Orabase	Participants assigned to this group will be treated with 50% bromelain gel formulated in orabase.

Primary Outcome Measures

Name	Time	Method
Pain associated with ulcers	Recorded at baseline, day 2, day 4 and day 7	Pain reduction will be measured using a visual analog scale (VAS). VAS is a self-reported pain scores ranging from 0 to 10

Secondary Outcome Measures

Name	Time	Method
Reduction in ulcer size	Recorded at baseline, day 2, day 4 and day 7	The reduction in ulcer size will be assessed using periodontal probe to measure dimensions in millimeters (mm)
Number of oral ulcers	Recorded at baseline, day 2, day 4 and day 7
Healing time of oral ulcer	Recorded at baseline, day 2, day 4 and day 7	The time to complete healing will be determined by the number of days until the ulcer is no longer visible upon clinical examination
Oral ulcer activity index	Recorded at baseline, day 2, day 4 and day 7	Oral ulcer activity index will be measured by Composite index (CI). CI score (0-10) is calculated by summing of subscale scores of oral ulcer activity (0 vs 1), oral ulcer-related pain status evaluated by categorized VAS (0-5) and the mean global functional disability score evaluated by 5-point Likert-type scale (0-4)