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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230823059238N2
Enrollment
32
Registered
2023-12-23
Start date
2023-12-11
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Oral lichen planus. Other lichen planus

Interventions

Intervention 1: Intervention group: Intervention group: Mg aluminum mouthwash and betamethasone 3 times, 5 cc each time, and 5 mg melatonin tablet 1 tablet two hours before bedtime for 9 weeks. Inter

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactYousef Navidpour

Tabriz University of Medical Sciences

Yousefnavidpour@gmail.com+98 41 3335 5965

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026