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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-60 years.

Diagnosed with RAS.

Onset of ulcer within the last 48 hours.

Willingness to participate and provide informed consent.

Disqualifiers

History of hematological deficiencies, GIT disorders, Behcet's disease and major systemic diseases.

Pregnant or breastfeeding patients.

Previous treatment for the current ulcer episode.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

63 Participants
are divided into 3 treatment groups
Group A: 35% Topical Bromelain in OrabaseExperimental treatment 1 intervention
Group B: 50% Topical Bromelain in OrabaseExperimental treatment 1 intervention
Group C: 0.1% Topical Triamcinolone Acetonide in OrabaseActive comparator 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

Reduction in ulcer size

The reduction in ulcer size will be assessed using periodontal probe to measure dimensions in millimeters (mm)

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

Number of oral ulcers

Time frame
Recorded at baseline, day 2, day 4 and day 7
3

Healing time of oral ulcer

The time to complete healing will be determined by the number of days until the ulcer is no longer visible upon clinical examination

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

Oral ulcer activity index

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)

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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