Efficacy of fluocinolone acetonide mouthwash versus dexamethasone mouthwash for symptomatic oral lichen planus treatment: a randomized clinical trial

Phase 2

Recruiting

• Conditions: Oral lichen planus; OLP

• Registration Number: TCTR20240610001
• Lead Sponsor: Facultry of dentistry, Chulalongkorn university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-10
• Last Update Posted: 19 August 2024
• Study Completion: 2026-04-04

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. Age 18 years old or above.
2. Patients can provide consent.
3. Patients can communicate well.
4. Patients have been clinically and histopathological diagnosed as OLP or compatible with OLP.
5. Patients have bilateral lesions with modified Thongprasom sign score at least 3 on both sides at the first visit of the study
6. Patients' NRS scores are at least 3 on the first visit of the study.
7. Patients present symptoms, corresponding to erosive/ulcerative or atrophic type of OLP.
8. OLP patients have no history of corticosteroid usage for at least 3 months.

Exclusion Criteria

1.Patients have histopathologic evidence of dysplasia.
2.Patients refuse to follow drug prescriptions.
3.Patients on long-term systemic corticosteroid therapy for other reasons that could not be discontinued.
4.Patients have uncontrolled diabetes mellitus or HbA1c > 8% or Fasting plasma glucose (FPG) > 180 mg/dl.
5.Patients have severe dry mouth with additive score of the Challacombe Scale of Clinical Oral Dryness > 7.
6.Patients have current immunosuppressant usage.
7.Patients have any active bacterial/fungal/viral infections at examination visit.
8.Patients have OLCL.
9.Patients have OLL-GVHD or history of allogenic bone marrow transplantation.
10.Patients have evidence of heavy smoking within the past 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total modified Thongprasom sign score at 1 months after end of the intervention Clinical examination by researcher

Secondary Outcome Measures

Name	Time	Method
umeric rating scale at 1 months after end of the intervention Patient reported outcome using a questionnaire interview,Oral Impact on Daily Performance(OIDP) score at 1 months after end of the intervention Patient reported outcome using a questionnaire interview,Fungal colony count at 1 months after end of the intervention Fungal colony count on Sabouraud's dextrose agar