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

NCT ID: NCT06033105

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2023-08-24

Brief Summary

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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

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Conditions

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Oral Lichen Planus Vitamin D Deficiency

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

35 OLP patients

ELISA

Intervention Type DEVICE

Enzyme-linked immunosorbent assay (ELISA) was used following manufacturer's instructions. This test uses a competitive ELISA-based technique that was designed to quantitatively determine the concentration of 1,25-dihydroxyvitamin D3/D2 in human serum.

Group B

35 healthy controls.

ELISA

Intervention Type DEVICE

Enzyme-linked immunosorbent assay (ELISA) was used following manufacturer's instructions. This test uses a competitive ELISA-based technique that was designed to quantitatively determine the concentration of 1,25-dihydroxyvitamin D3/D2 in human serum.

Interventions

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ELISA

Enzyme-linked immunosorbent assay (ELISA) was used following manufacturer's instructions. This test uses a competitive ELISA-based technique that was designed to quantitatively determine the concentration of 1,25-dihydroxyvitamin D3/D2 in human serum.

Intervention Type DEVICE

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fayoum University

OTHER

Sponsor Role lead

Responsible Party

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Salsabeel A Afifi, PhD

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fayoum University

Al Fayyum, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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2191982

Identifier Type: -

Identifier Source: org_study_id

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