Investigating the effect of melatonin combined with betamethasone mouthwash compared to betamethasone mouthwash alone in the treatment of ulcerative oral lichen planus

Phase 3

Recruiting

Conditions: Oral lichen planus.
Other lichen planus
L43.8

Registration Number: IRCT20230823059238N2

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 32

Inclusion Criteria

Definitive diagnosis of ulcerative oral lichen planus based on clinical findings: white and red components with different designs, presence of reticular or papular tissue with erogenous lesions and histopathological criteria: 1) hyperparakeratosis or hyperorthokeratosis areas, often with thickening of the granular cell layer and a saw-tooth appearance in Rat pegs 2) Condensed degeneration or necrosis in the basal cell layer 3) An eosinophilic band that may be seen just below the basement membrane and contains fibrin covering the lamina propria. 4) Dense subepithelial band-like infiltration of lymphocytes and macrophages 5- Presence Ulcer or fibrinopurulent membrane
Patients with complete records including demographic and clinical information
Patients without underlying disease
People who have the ability to give informed consent and do not need a legal representative.

Exclusion Criteria

pregnant women
People with underlying disease
Any treatment that has been done for these injuries
Use of immunosuppressive drugs
Incomplete file
The patient's unwillingness to participate in the research

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of pain. Timepoint: Before starting the intervention, 4 and 9 weeks after the intervention. Method of measurement: The severity of pain will be evaluated through visual analogue scale (VAS).;The size of the lesions. Timepoint: Before starting the intervention, 4 and 9 weeks after the intervention. Method of measurement: The size of the lesions will be measured with the help of gauze paper.;Appearance of lesions. Timepoint: Before starting the intervention, 4 and 9 weeks after the intervention. Method of measurement: The appearance of lesions will be measured by Thongprasom scale and includes 6 grades: zero = perfectly healthy, 1 = mild white lines without inflammatory regions, 2 = white lines with atrophic regions smaller than 1 cm2, 3 = white lines with atrophic regions larger than 1 cm2, 4 = white lines accompanied with erosive regions less than 1 cm2, 5 = white lines with erosive areas larger than 1 cm2.

Secondary Outcome Measures