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NCT Number: NCT06993337

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

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.

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Key information

Conditions

Recurrent Aphthous Stomatitis Mouth Diseases Stomatitis Stomatitis, Aphthous Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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

Primary outcomes

  1. Pain associated with ulcers

    Time frame: 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 outcomes

  1. Reduction in ulcer size

    Time frame: 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)

  2. Number of oral ulcers

    Time frame: Recorded at baseline, day 2, day 4 and day 7

  3. Healing time of oral ulcer

    Time frame: 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

  4. Oral ulcer activity index

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Topical Bromelain Versus Topical Corticosteroids in Management of Recurrent Aphthous Stomatitis: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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