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

Phase 4

Not yet recruiting

• Conditions: Lichen Planus, Oral
• Interventions: Drug: Triamcinolone Acetonide 0.1% Oint; Drug: Selenium& Tacrollimus topical; Drug: Tacrollimus Topical; Drug: Selenium; Drug: Selenium & Triamcinolone Acetonide 0.1% Oint

• Registration Number: NCT06362005
• Lead Sponsor: Al-Azhar University

Brief Summary

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

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 .

Study Timeline

• Study First Submitted: 2024-03-27
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Study Start: 2025-10-03
• Primary Completion: 2025-12-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• clinical diagnosis of OLP

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group I (triamcinolone)	Triamcinolone Acetonide 0.1% Oint	ten patients with oral lichen planus, will receive topical triamcinolone acetonide 0.1% four times per day for six weeks.
group V ( selenium + tacrollimus)	Selenium& Tacrollimus topical	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 II (tacrollimus)	Tacrollimus Topical	ten patients with oral lichen planus, will receive topical tacrolimus 0.1% four times per day for six weeks.
group III (selenium)	Selenium	ten patients with oral lichen planus, will receive topical selenium four times per day for six weeks.
group IV (selenium + triamcinolone )	Selenium & Triamcinolone Acetonide 0.1% Oint	: 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

Primary Outcome Measures

Name	Time	Method
to assess a visual analog scale (VAS)of the oral lichen planus lesion	baseline, 1, 3 and 6 months after treatment	qualitative

Secondary Outcome Measures

Name	Time	Method
to assess The associated Oral Disease Severity Score 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis	baseline, 1, 3 and 6 months after treatment	qualitative ,and quantitiave
Biochemical evaluation of salivary Glutathione level using (ELISA)	baseline, 1, 3 and 6 months after treatment	Quantity

Trial Locations

Locations (1)

Alazhar university ,faculty of Dental Medicine; 🇪🇬 Assiut, Egypt