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OpenTrials
Completed

NCT Number: NCT06033105

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

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.

Completed

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Key information

Conditions

Oral Lichen Planus Avitaminosis Deficiency Diseases Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Malnutrition Mouth Diseases Nutrition Disorders Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases Vitamin D Deficiency

Sex eligibility

All sexes

Study type

Observational

Primary location

Fayoum University

Al Fayyum, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ELISA

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.

Primary outcomes

  1. serum vitamin D level in OLP

    Time frame: 1 month

    measured by ELISA

Secondary outcomes

  1. serum vitamin D level in correlation with sex, dietary habits and sun exposure.

    Time frame: 1 month

    Questionnaire, measured in proportions

  2. serum vitamin D level in correlation with socioeconomic status

    Time frame: 1 month

    Kuppuswamy's socioeconomic status scale

  3. serum vitamin D level in correlation with Psychological factors

    Time frame: 1 month

    Depression Anxiety and Stress Scale 21 (DASS-21)

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

Vitamin D Deficiency As a Risk Factor for the Development and Malignant Transformation of Oral Lichen Planus: a Case-control Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2023
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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