Clinical trial NCT06204796: The Role of Vitamin D in Amelioration of Oral Lichen Planus and Its Effect on Salivary IFN-γ Level
Official title: The Role of Vitamin D in Amelioration of Oral Lichen Planus and Its Effect on Salivary IFN-γ Level: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Lichen Planus
Vitamin D Deficiency
Keywords: vitamin D, Oral Lichen Planus, salivary IFN-γ
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare between the use of vitamin D supplement in conjunction with systemic steroids versus the use of systemic steroids alone in the management of patients with symptomatic Oral Lichen Planus lesions and the comparison of salivary Interferon gamma levels in both study groups before and after treatment

Detailed description: The objective of the research:

To investigate the role of vitamin D supplements in the management of vitamin D deficient oral lichen planus (OLP) patients and to examine its suppressive effect on pro-inflammatory cytokine (IFN-γ) in saliva samples of OLP patients

• Steps in short

1- Trial design: This study is a randomized clinical trial (RCT) having parallel groups with a 1:1 allocation ratio. This study will conform with the Consolidated Standards of Reporting Trials guidelines (CONSORT guidelines).

Middle-aged patients presenting with clinical and histopathological features of symptomatic (atrophic, erosive, or bullous) OLP (32) and having vitamin D deficiency or insufficiency (≤30 ng/ml) (33) will be included in the present study.

4-Intervention and study groups A total of 40 participants will be randomly and equally allocated into one of the two study groups to receive either, systemic steroids and vitamin D supplement (intervention) or systemic steroids only (control).

Clinical evaluation of the lesion through two components including objective morphological signs and subjective symptoms that describe the pain and burning sensation; will be measured at baseline and after 4 weeks of treatment

* Subjective findings (symptoms) using VAS score or burning sensation and pain ranging from 0 to 10 Changes in salivary INF-γ level (pg/mL) at baseline and after 4 weeks of treatment (measured using ELIZA technique)
* Treatment administration All participants will receive 40-60 mg of systemic prednisone as a single morning dose according to the severity. in the intervention group, a vitamin D supplement will be given as 60,000 IU weekly in conjunction with systemic steroids.

For the measurement of vitamin D3, The enzyme-linked immunosorbent assay (ELISA) will be used to process all samples simultaneously. Vitamin D levels lower than 30 ng/ml were assigned to vitamin D deficiency or insufficiency.

-Measurement of the inflammatory mediator (IFN-γ ) in saliva using (ELISA) kit After the initial diagnosis visit (during recruitment), patients will be clinically examined again for assessment of outcomes at baseline and after 1 month of treatment. Patients will be followed up for up to 60 days.

Eligibility criteria: Inclusion Criteria:

* Middle-aged patients
* Clinical and histopathological features of symptomatic (atrophic, erosive, or bullous) OLP
* Vitamin D deficiency or insufficiency (≤30 ng/ml)

Exclusion Criteria:

* Oral mucosal lesion other than OLP
* Suspected restoration-related reaction
* Active periodontitis
* Patients receiving any topical or systemic medication that may affect SVDL or induce a lichenoid reaction
* Patient having systemic disease based on the detailed questionnaire of the modified Cornell Medical Index

Primary outcomes:
measure: Severity of clinical presentation of the lesion
timeFrame: 1 months
measure: Pain and burning sensation
timeFrame: 1 months
Secondary outcomes:
measure: Changes in salivary INF-γ level
timeFrame: 1 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Rania Hassan Shalby
Study officials:
affiliation: Faculty of Dentistry-Fayoum University
name: Rania H Shalby
role: PRINCIPAL_INVESTIGATOR
affiliation: Modern modern university for technology and information MTI University
name: Yasmine G Hamid, phd
role: PRINCIPAL_INVESTIGATOR
References: