The Role of Vitamin D in Amelioration of Oral Lichen Planus and Its Effect on Salivary IFN-γ Level

NCT06204796 | Completed Phase 4

• 1 other identifier: 19038219038211013
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Lichen Planus; Vitamin D Deficiency

Keywords

vitamin D, Oral Lichen Planus, salivary IFN-γ

Outcome Measures

Primary Outcomes (2)

• Severity of clinical presentation of the lesion

  The severity of the clinical presentation of the lesion was calculated by multiplying (Sub-site score A) by (Severity score B) as Sub-site score A 0= no lesion 1. evidence of lichen planus 2. ≥50% of buccal mucosa, dorsum of the tongue, the floor of the mouth, hard palate, soft palate, or oropharynx affected Severity score B 0= keratosis only 1. keratosis with mild erythema (≤ 3 mm from gingival margin) 2. marked erythema (e.g. full thickness of gingivae, extensive with atrophy or edema on non-keratinized mucosa) 3. ulceration present Severity of clinical appearance=A\*B (sub-site score\* severity score) * Mild: 1-2 * Moderate: 3-4 * Severe: 5-6 Finally, the lesion was considered as persisting at follow-up if the clinical presentation score was greater than 0 where whereas a score of 0 indicated a healed lesion.

  1 months

• Pain and burning sensation

  VAS score or burning sensation and pain ranging from 0 to 10 * Mild : 0-4 * Moderate: 5-7 * Severe: 8-10

  1 months

Secondary Outcomes (1)

• Changes in salivary INF-γ level

  1 months

Study Arms (2)

Vitamin D+ Systemic steroids

ACTIVE COMPARATOR

vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic steroids.

Drug: vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic prednisone; Drug: Systemic prednisone

Systemic steroids alone

ACTIVE COMPARATOR

systemic steroids only

Drug: Systemic prednisone

Interventions

vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic prednisone DRUG

All participants received 40-60 mg of systemic prednisone as a single morning dose according to the severity of the condition until a 50% reduction in lesion size was achieved then the dose was tapered by 10mg each week and finally to 5 mg/day for the last week. Patients were followed up weekly for up to 60 days. The length and dose of treatment were adjusted according to clinical needs in each case. In addition, a vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic steroids.

Vitamin D+ Systemic steroids

Systemic prednisone DRUG

All participants received 40-60 mg of systemic prednisone as a single morning dose according to the severity of the condition until a 50% reduction in lesion size was achieved then the dose was tapered by 10mg each week and finally to 5 mg/day for the last week. Patients were followed up weekly for up to 60 days. The length and dose of treatment were adjusted according to clinical needs in each case.

Systemic steroids alone; Vitamin D+ Systemic steroids

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Rania Hassan Shalby

Giza, Egypt

Location

MeSH Terms

Conditions

Lichen Planus, Oral; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Rania H Shalby

  Faculty of Dentistry-Fayoum University

  PRINCIPAL INVESTIGATOR

• Yasmine G Hamid, phd

  Modern modern university for technology and information MTI University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral Medicine

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: January 12, 2024
• Study Start: August 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)