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

ConditionOral Aphthous Ulcers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCairo University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Rebamipide mouthwashExperimental treatment 1 intervention
Group B: Betamethasone mouthwashActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain intensity associated with oral aphthous ulcers

pain from oral ulcers will be assessed through visual analogue scale

Time frame
During the first week (days 0, 3,5 and 7)

Secondary outcomes

1

Number of oral ulcers

Number of oral ulcers will be determined through clinical examination

Time frame
During the first week (days 0, 3,5 and 7)
2

healing time of oral ulcers

healing time of oral ulcers will be determined through clinical examination

Time frame
During the first week (days 0, 3,5, and 7)
3

Diameter of oral ulcers

Diameter of oral ulcers will be determined through clinical examination

Time frame
During the first week (days 0, 3,5 and 7),

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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