A randomised clinical trial of the efficacy of topical and systemic treatment on recurrent oral ulcers

Phase 4

Completed

• Conditions: Aphthous stomatitis; Oral Health; Recurrent aphthous stomatitis

• Registration Number: ISRCTN32677164
• Lead Sponsor: Guys and St Thomas NHS Trust

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37789351/ (added 04/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-04-07
• Study Start: 2018-04-15
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Diagnosed with RAS (defined as recurrent oral ulcers of unknown aetiology characterised by the spontaneous emergence of more than two bouts of oral ulcers per year, not associated with ulcers elsewhere in the body or with an underlying systemic abnormality).
2. Aged between 18-65 years.
3. Willing and able to give informed consent to participate in the study.
4. Not involved in other studies that would compromise their safety or undermine the scientific basis of the study.

Exclusion Criteria

1. Unable to give informed consent.
2. Unwilling or unable to comply with the study protocol.
3. Pregnant or breast feeding.
4. Atopic or have severe or relevant history of allergy, hypersensitivity or side effects to any of the study medications.
5. Diagnosed with systemic diseases thought to overlap with RAS i.e. Behcet’s disease, HIV, haematological deficiencies, gastrointestinal or dermatological disorders.
6. Patients with a current or past history of cardiac, renal,or hepatic disease.
7. Patients who were on any type of local or systemic Steroids or on Colchicine currently or in the previous three months.
8. Patients who are debilitated in any way.

Study & Design

• Study Type: Interventional
• Study Design: Not specified