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

Lichen Planus, Oral Clinical Trial

— RCT  

Official title:

The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus (Randomized Clinical Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362005
• Other study ID #: AUAREC2023011-1
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2024
• Source: Al-Azhar University
• Contact: Shimaa HR Kotb, Doctoral thesis
• Phone: +201062051669
• Email: shaymarafat.dental[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of OLP

Exclusion Criteria:

1. lichenoid reaction from medication ' .

2. any systemic autoimmune disease

3. Pregnancy

4. smokers

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral

Intervention

Drug:
• Triamcinolone Acetonide 0.1% Oint
RCT
• Tacrollimus Topical
RCT
• Selenium
RCT
• Selenium & Triamcinolone Acetonide 0.1% Oint
RCT
• Selenium& Tacrollimus topical
RCT

Locations

Country	Name	City	State
Egypt	Alazhar university ,faculty of Dental Medicine	Assiut

Sponsors (2)

Lead Sponsor	Collaborator
Al-Azhar University	Sphinx university

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to assess a visual analog scale (VAS)of the oral lichen planus lesion	qualitative	baseline, 1, 3 and 6 months after treatment
Secondary	to assess The associated Oral Disease Severity Score 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis	qualitative ,and quantitiave	baseline, 1, 3 and 6 months after treatment
Secondary	Biochemical evaluation of salivary Glutathione level using (ELISA)	Quantity	baseline, 1, 3 and 6 months after treatment

External Links

•   ncbi
•   Orchid