Trials Sponsors Conditions Drugs Pricing

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 prednisoneDrug: 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 prednisoneDrug

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 prednisoneDrug

Eligibility Criteria

Age35 Years - 55 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Middle-aged patients
Clinical and histopathological features of symptomatic (atrophic, erosive, or bullous) OLP

Sponsors & Collaborators

Fayoum University
Otherlead

Study Sites (1)

Rania Hassan Shalby

Giza, Egypt

MeSH Terms

Conditions

Lichen Planus, OralVitamin D Deficiency

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional 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

Enrollment

40 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Vitamin D+ Systemic steroids

Systemic steroids alone

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Vitamin D+ Systemic steroids

Systemic steroids alone

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations