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Effect of Gamma-oryzanol in Lichen Planus

Comparison of the Effect of Gamma-oryzanol Mucoadhesive paste with Betamethasone Mouthwash and Betamethasone Mouthwash Alone on Clinical Manifestations and Pain Severity in Oral Lichen Planus Patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250106064298N1
Enrollment
38
Registered
2025-02-18
Start date
2025-02-19
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Symptomatic oral lichen planus lesions. Other lichen planus

Interventions

Intervention 1: Intervention group: At the beginning, plastic base is prepared. This base is made of polyethylene and liquid paraffin, with the explanation that polyethylene is added to liquid paraffi

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Definitive diagnosis of Oral Lichen Planus based on clinical and histopathological findings of patients with at least one visible and measurable ulcerative or atrophic or reticular Oral Lichen Planus lesion Patients who have not received immunosuppressive drugs Absence of dysplasia Absence of underlying disease Completeness of the file including demographic and clinical information

Exclusion criteria

Exclusion criteria: Allergy to betamethasone or gamma-oryzanol mouthwash There are only reticular lines in the patient's mouth and the lichen planus is painless The presence of uncontrolled diabetes Blood pressure and other underlying diseases that can interfere with participation and compliance with the study Immunosuppression Hepatitis (because corticosteroid suppresses the immune system and increases the likelihood of viremia) The use of lichenoid reaction drugs or the presence of amalgam repair in the vicinity of the lesion The presence of skin or other mucosal destruction lesions Patients with oral candidiasis Receiving treatment for oral lichen planus in the past 12 weeks Viral infections Pregnancy and breastfeeding

Design outcomes

Primary

MeasureTime frame
Clinical score based on Thongprasom's scale. Timepoint: At the beginning of the intervention, 4 weeks later, 8 weeks later, 12 weeks later. Method of measurement: The clinical score will be calculated based on Thongprasom's scale: grade 0 = no lesion / normal mucosa grade 1 = white striae / no erythematous area grade 2 = white striae with an atrophic area equal to or less than 1 cm2 grade 3 = white striae with area Atrophic more than 1 cm2 grade 4 = white stretch marks with erogenous area equal to or less than 1 cm2 grade 5 = white stretch marks with erogenous area more than 1 cm square meter.;Pain score using Visual Analogue Scale. Timepoint: At the beginning of the intervention, 4 weeks later, 8 weeks later, 12 weeks later. Method of measurement: Pain will be evaluated using the VAS (Visual Analogue Scale) scale, which includes a 10 cm horizontal line from 0 = no pain, to 10 = the most severe pain experienced, and the patient chooses a number based on the pain intensity.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Kooh Soltani

Tabriz University of Medical Sciences

mkoohsoltani@yahoo.com+98 41 3334 0310

Outcome results

None listed

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