Vitamin D Deficiency As a Risk Factor for the Development and Malignant Transformation of Oral Lichen Planus

Completed

• Conditions: Oral Lichen Planus; Vitamin D Deficiency
• Interventions: Device: ELISA

• Registration Number: NCT06033105
• Lead Sponsor: Fayoum University

Brief Summary

To examine how a lack of vitamin D may increase the risk of developing oral lichen planus and its malignant progression while accounting for sex, food habits, sunlight, socioeconomic level, and psychological variables.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Primary Completion: 2023-08-24
• Study Completion: 2023-08-24
• Status Verified: 2023-09
• Study First Submitted: 2023-09-02
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-13
• Last Update Submitted: 2024-11-17
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• (Group A) patients presenting with a clinical picture and histological findings that confirm the diagnosis of OLP
• (Group B) age, sex, and dietary habits matched healthy controls.

Exclusion Criteria

• (1) subjects who have been receiving any kind of VD supplements, multivitamins, or any drug that may affect VD measurements
• (2) patients with suspected restoration-related or smokeless tobacco-related lesions.
• (3) patients with any systemic medical condition or pregnant females.
• (4) patients with VD toxicity (VD≥100 ng/ml).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	ELISA	35 healthy controls.
Group A	ELISA	35 OLP patients

Primary Outcome Measures

Name	Time	Method
serum vitamin D level in OLP	1 month	measured by ELISA

Secondary Outcome Measures

Name	Time	Method
serum vitamin D level in correlation with sex, dietary habits and sun exposure.	1 month	Questionnaire, measured in proportions
serum vitamin D level in correlation with socioeconomic status	1 month	Kuppuswamy's socioeconomic status scale
serum vitamin D level in correlation with Psychological factors	1 month	Depression Anxiety and Stress Scale 21 (DASS-21)

Trial Locations

Locations (1)

Fayoum University; 🇪🇬 Fayoum, Egypt