Adjunctive Oral Systemic Vitamin E Therapy on Salivary Nitric Oxide Level in Patients With Erosive Oral Lichen Planus

Not Applicable

Completed

• Conditions: Lichen Planus
• Interventions: Drug: Topical corticosteroid and Vitamin E; Drug: Topical corticosteroid

• Registration Number: NCT05787925
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

Oral lichen planus (OLP) is a chronic inflammatory disease affecting the skin, mucous membranes,s and rarely scalp and nails. It is a T-cell-mediated autoimmune disease. Traditional treatment for OLP is topical steroids commonly used to treat mild to moderately symptomatic lesions. Recent treatment modalities for oral lichen planus include micronutrients such as antioxidants including vitamin E that modify the immune system function. The aim of this study is to evaluate the efficacy of adjunctive oral systemic vitamin E therapy on salivary nitric oxide levels in patients with erosive oral lichen planus.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-20
• Status Verified: 2023-03
• Primary Completion: 2023-03-05
• Study Completion: 2023-03-05
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-15
• Last Update Submitted: 2023-03-15
• Study First Posted: 2023-03-28
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Patients who are clinically and histopathologically confirmed of having erosive OLP according to modified WHO criteria.
• Patients with erosive OLP patients who will agree to take supplied medications.
• Ability to complete this trial.

Exclusion Criteria

• OLP patients receiving any systemic treatment such as systemic steroids, other immunosuppressive drugs, or non-steroidal anti-inflammatory drugs on past 3 months.
• Pregnant and breast-feeding females.
• Patients suffering from systemic diseases.
• Patients with lesions showing any dysplastic changes in the biopsy specimen.
• Patients who are smoking and tobacco users in any form, will not be included.
• Patients with both lichenoid contact reaction and lichenoid drug reactions.
• Patients with cutaneous lichen planus lesions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical corticosteroid and Vitamin E	Topical corticosteroid and Vitamin E	-
Topical corticosteroid	Topical corticosteroid	-

Primary Outcome Measures

Name	Time	Method
Change in oral lesion	At baseline,4th week and 8th week	whole treatment response and the size of the oral lesions will be recorded using Thongprasom et al. scoring system, score 5 was assigned to patients having white striae with erosive areas \>1 cm2, score 4 for patients with white striae and erosive areas \<1 cm2, score 3 for those having white striae and atrophic areas \>1 cm2, score 2 for those having white striae and atrophic areas \<1 cm2, score 1 for those having only white striae, and score 0 for normal mucosa
Change in pain score	At baseline,4th week and 8th week	At baseline, 4th week and 8th week after the treatment, burning sensation using Visual Analogue Scale (VAS) will be measured on a 10-point (0 = no symptoms, 10 = severe pain)

Secondary Outcome Measures

Name	Time	Method
Change in salivary nitric oxide	At baseline,4th week and 8th week	Patients will be asked to rinse their mouth with 5 ml of normal saline for 3 min then tilt their head forward and expectorate saliva into a sterile beaker without swallowing. The saliva samples will be stored at -20 ºC till the time of analysis. It depends on the addition of Griess Reagents which convert nitrite into a deep purple azo compound; photometric measurement of the absorbance due to this azo chromophore accurately determines NO2-concentration

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt