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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240610001
Enrollment
74
Registered
2024-06-10
Start date
2024-04-05
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral lichen planus OLP

Interventions

Medicines will be administered as mouthwash without dilution at a dosage of 15 mL measured by measuring cups two times daily after breakfast and after dinner. Patients will be instructed to rinse for
Active Comparator Drug,Experimental Drug
0.05% Dexamethasone mouthwash,0.05% Fluocinolone mouthwash

Sponsors

Facultry of dentistry, Chulalongkorn university
Lead Sponsor
The Royal College of Dental Surgeons of Thailand
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Total modified Thongprasom sign score at 1 months after end of the intervention Clinical examination by researcher

Secondary

MeasureTime frame
Numeric 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

Countries

Thailand

Contacts

Public ContactPanipak Assawasongsilp

Chulalongkorn university

panipakassa@gmail.com0929145366

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026