The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus

NCT ID: NCT06362005

Last Updated: 2025-12-31

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

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-10-01

Brief Summary

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evaluate clinically and biochemically the efficacy of topically applied selenium as complementary or alternative to triamcinolone acetonide 0.1% and tacrolimus 0.1% in patients with oral lichen planus.

Detailed Description

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The signs and symptoms of the oral lichen planus lesion. 2-The associated oral symptoms. 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis .

Conditions

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Lichen Planus, Oral

Keywords

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seleinum Antioxidant Glutathione-S-transferases Reactive oxygen species

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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group I (triamcinolone)

ten patients with oral lichen planus, will receive topical triamcinolone acetonide 0.1% four times per day for six weeks.

Group Type PLACEBO_COMPARATOR

Triamcinolone Acetonide 0.1% Oint

Intervention Type DRUG

RCT

group II (tacrollimus)

ten patients with oral lichen planus, will receive topical tacrolimus 0.1% four times per day for six weeks.

Group Type PLACEBO_COMPARATOR

Tacrollimus Topical

Intervention Type DRUG

RCT

group III (selenium)

ten patients with oral lichen planus, will receive topical selenium four times per day for six weeks.

Group Type EXPERIMENTAL

Selenium

Intervention Type DRUG

RCT

group IV (selenium + triamcinolone )

: ten patients with oral lichen planus, will receive topical selenium combined with topical triamcinolone acetonide 0.1% three times per day for each for six weeks

Group Type EXPERIMENTAL

Selenium & Triamcinolone Acetonide 0.1% Oint

Intervention Type DRUG

RCT

group V ( selenium + tacrollimus)

ten patients with oral lichen planus, will receive topical selenium combined with topical tacrolimus 0.1% three times per day for each for six weeks.

Group Type EXPERIMENTAL

Selenium& Tacrollimus topical

Intervention Type DRUG

RCT

Interventions

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Triamcinolone Acetonide 0.1% Oint

RCT

Intervention Type DRUG

Tacrollimus Topical

RCT

Intervention Type DRUG

Selenium

RCT

Intervention Type DRUG

Selenium & Triamcinolone Acetonide 0.1% Oint

RCT

Intervention Type DRUG

Selenium& Tacrollimus topical

RCT

Intervention Type DRUG

Other Intervention Names

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Group I Group II Group III Group IV Group V

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of OLP

Exclusion Criteria

1. lichenoid reaction from medication ' .
2. any systemic autoimmune disease
3. Pregnancy
4. smokers
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sphinx university

OTHER

Sponsor Role collaborator

Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Shaymaa Hussein Rafat Kotb

Assistant lecturere of oral medicine ,periodontology departement

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alazhar university ,faculty of Dental Medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

Related Links

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Other Identifiers

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AUAREC2023011-1

Identifier Type: -

Identifier Source: org_study_id