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

NCT06993337 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: OMED 372
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Recurrent Aphthous Stomatitis

Outcome Measures

Primary Outcomes (1)

• Pain associated with ulcers

  Pain reduction will be measured using a visual analog scale (VAS). VAS is a self-reported pain scores ranging from 0 to 10

  Recorded at baseline, day 2, day 4 and day 7

Secondary Outcomes (4)

• Reduction in ulcer size

  Recorded at baseline, day 2, day 4 and day 7

• 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

• Oral ulcer activity index

  Recorded at baseline, day 2, day 4 and day 7

Study Arms (3)

35% Topical Bromelain in Orabase

EXPERIMENTAL

Participants in this group will receive 35% bromelain gel incorporated into an orabase adhesive medium.

Dietary Supplement: 35% Topical Bromelain in Orabase

50% Topical Bromelain in Orabase

EXPERIMENTAL

Participants assigned to this group will be treated with 50% bromelain gel formulated in orabase.

Dietary Supplement: 50% Topical Bromelain in Orabase

0.1% Topical Triamcinolone Acetonide in Orabase

ACTIVE COMPARATOR

This group will receive the standard treatment of 0.1% triamcinolone acetonide in orabase, commonly used for managing Recurrent Aphthous Stomatitis.

Drug: 0.1% Topical Triamcinolone Acetonide in Orabase

Interventions

35% Topical Bromelain in Orabase DIETARY_SUPPLEMENT

Bromelain is a natural proteolytic enzyme derived from pineapple, recognized for its broad range of pharmacological properties. It exhibits significant anti-inflammatory effects by reducing edema. In addition to its anti-inflammatory activity, bromelain possesses antioxidant and analgesic properties.

35% Topical Bromelain in Orabase

50% Topical Bromelain in Orabase DIETARY_SUPPLEMENT

Bromelain is a natural proteolytic enzyme derived from pineapple, recognized for its broad range of pharmacological properties. It exhibits significant anti-inflammatory effects by reducing edema. In addition to its anti-inflammatory activity, bromelain possesses antioxidant and analgesic properties.

50% Topical Bromelain in Orabase

0.1% Topical Triamcinolone Acetonide in Orabase DRUG

Triamcinolone acetonide in orabase, a corticosteroid-based standard treatment for Recurrent Aphthous Stomatitis (RAS), is used for its strong anti-inflammatory and immunosuppressive effects. In this study, it serves as the conventional treatment against the novel therapy

0.1% Topical Triamcinolone Acetonide in Orabase

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Stomatitis, Aphthous

Interventions

Bromelains; Orabase; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cysteine Endopeptidases; Cysteine Proteases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Endopeptidases; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student in Oral Medicine

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 28, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05