Evaluating Treatment Efficacy in Oral Lichen Planus: The Role of Salivary Biomarkers

Not Applicable

Completed

• Conditions: Oral Lichen Planus; Oral Lichen Planus Related Stress
• Interventions: Combination Product: Acetonide triamcinolone 0.2% +hyaluronicacid 1%; Drug: Corticoid Acetonide triamcinolone 0.2%; Drug: Hyaluronic acid 1%

• Registration Number: NCT06332365
• Lead Sponsor: Pia Lopez Jornet

Brief Summary

Lichen planus, a chronic autoimmune mucocutaneous disorder, affects 0.5% to 2.2% of diverse populations. The treatment for oral lichen planus (OLP) includes a range of options, both topical and systemic therapies. Recent research has highlighted the potential of hyaluronic acid as a drug alternative, potentially offering effective management for OLP and alleviating the discomfort of this chronic condition. The objective was to assess the impact of topical hyaluronic acid on salivary oxidative stress markers in individuals suffering from oral lichen planus

Detailed Description

Interventional (Clinical Trial) Actual Enrollment : 60 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Care Provider, Outcomes Assessor) Masking Description: The clinical outcomes were assessed by an investigator masked about the treatment modality that has been used Primary Purpose: Treatment Pain , quality of life the study on oral lichen planus, three treatment groups were established:

Group I: Received a combination of 0.1% hyaluronic acid and 0.2% triamcinolone acetonide.

Group II: Was treated solely with 0.2% triamcinolone acetonide. Group III: Received only 0.1% hyaluronic acid. These groups were designed to evaluate and compare the efficacy of different treatments in patients with oral lichen planus.

Study Timeline

• Study Start: 2022-01-03
• Primary Completion: 2023-12-15
• Status Verified: 2024-02
• Study Completion: 2024-02-19
• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-25
• Last Update Submitted: 2024-03-25
• Study First Posted: 2024-03-27
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients with diagnosis oral lichen planus. Patients with no history of taking corticosteroids for the last 6 months Patients who agrees to take medication.

Exclusion Criteria

Pregnant and lactating ladies. Patients with recent dental filling associated with the lesion or associated with recent drug administration.

Patient with uncontrolled diabetes, uncontrolled hypertension,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I experimental	Acetonide triamcinolone 0.2% +hyaluronicacid 1%	Group I: Received a combination of 0.1% hyaluronic acid and 0.2% triamcinolone acetonide.
Group II	Corticoid Acetonide triamcinolone 0.2%	Was treated exclusively with 0.2% triamcinolone acetonide.
Group III	Hyaluronic acid 1%	Received only 0.1% hyaluronic acid.

Primary Outcome Measures

Name	Time	Method
Pain assessment scale	4 weeks	visual analog scale (VAS) score 0-10 higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
OHIP-14 questionnaire	4 weeks	evaluate the oral health related quality of life score 0-56 higher scores mean a worse outcome
reduction of clinical signs measure	4 weeks	Thongprasom Score 5 = white striae with erosive area = 1 cm2 Score 4 = white striae with erosive area \< 1 cm2 Score 3 = white striae with erosive area \> 1 cm2 Score 2 = white striae with atrophic area \< 1 cm2 Score 1 = mild white striae only Score 0 = no lesion normal
Salivary level of oxidative stress biomarker	4 weeks	Salivary level of oxidative stress biomarker Amilase; Glutation, IgA, FRAP, ADA

Trial Locations

Locations (1)

Pia Lopez Jornet; 🇪🇸 Murcia, Spain