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RECRUITING Phase 2 ClinicalTrials.gov

Evaluation of Topical Rebamipide Versus Topical Betamethasone for Treatment of Oral Aphthous Ulcers

Sponsor: Cairo University • ClinicalTrials.gov ID: NCT06084624

Registry updated: 2026-10-06
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Description

The goal of this randomized clinical trial is to to compare the effect of topical rebamipide to topical betamethasone on pain intensity in patients having recurrent oral aphthous ulcers. The main question it aims to answer is : What is the effect of topical Rebamipide mouthwash compared to topical betamethasone mouthwash on pain reduction in patients with oral aphthous ulcers? Participants will will be divided randomly into the two groups and the following outcomes will be measured: Pain associated with oral ulcers Number of oral ulcers Diameter of oral ulcers Healing time of oral ulcers

Interventions

  • Rebamipide mouthwash (Drug)
    Rebamipide (REB), 2-(4-chlorobenzoylamino)-3-\[2(1H)-quinolinone-4-yl\]-propionic acid, is commonly used in cases of gastric ulcers, gastritis, and dry eye syndrome
  • Betamethasone mouthwash (Drug)
    Betamethasone is a potent glucocorticoid steroid. It is very soluble in water, and therefore it can be used as a mouthwash and has been used for symptomatic relief and treatment of recurrent aphthous ulcers

Eligibility criteria

Inclusion criteria: Patients age from 18-70 years old. Patients with active oral ulcers. History of recurrent ulcers in the oral cavity Patients free from any visible oral lesions other than the oral aphthous ulcers. Patient who will agree to participate in the study and take the supplied interventions. E8glusion criteria: * Patients with history of a severe or chronic medical condition including congestive heart failure, malignancy and active infection including tuberculosis, hepatitis and human immunodeficiency virus. * Patients under immunosuppressive drugs. * Patients using topical or systemic treatment agents for the oral ulcers

Conditions

Oral Aphthous Ulcers

Locations

  • Faculty of dentistry, Cairo University — Cairo, Egypt
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record