Evaluation of Efficacy of Neem (Azadirachta Indica) Versus Triamcinolone Acetonide in the Treatment of Oral Lichen Planus.

Not Applicable

Completed

• Conditions: Oral Lichen Planus
• Interventions: Drug: Neem gel; Drug: Triamcinolone Acetonide

• Registration Number: NCT07141446
• Lead Sponsor: Goa Dental College

Brief Summary

The goal of this clinical trial is to learn if Neem works to treat Oral Lichen Planus in adults. It will also learn about the safety of Neem in oral lesions. The main questions it aims to answer are:

To compare the efficacy of 1.5% Neem Gel (Azadirachta Indica) versus 0.1% Triamcinolone Acetonide in treatment of Oral Lichen Planus (OLP) as a topical treatment modality for patients with OLP,

Researchers will compare Neem to a corticosteroid (a standard treatment for Oral Lichen Planus) to see if Neem works to treat Oral Lichen Planus.

Participants:

In experimental group were given Neem Gel in Orabase formulations and control group with topical Triamcinolone acetonide oral paste to be used twice every day for 3 months Visit the clinic once every month for checkups.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-05
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-28
• Status Verified: 2025-02
• Study First Submitted: 2025-08-19
• Study First Submitted QC: 2025-08-19
• Study First Posted: 2025-08-26
• Last Update Submitted: 2025-08-26
• Last Update Posted: 2025-09-03

Recruitment & Eligibility

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

Inclusion Criteria

• Patient with clinical & histopathological diagnosis of OLP.
• Patient above 20 years of age.
• Patient willing to participate in the study with informed consent.
• Patient with recalcitrant OLP.

Exclusion Criteria

• Patient with known allergic reaction to Triamcinolone Acetonide or Neem.
• Patients with lichenoid lesions.
• Patients with associated cutaneous lesions.
• Pregnant or lactating females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neem	Neem gel	-
Triamcinolone Acetonide	Triamcinolone Acetonide	-

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	From enrollment to the end of 3 months	Burning sensation will be evaluated with Visual Analogue scale
Thongprasom's Score	From enrollment to the end of the 3 months	clinical severity of lesion
OLP Disease Severity Score	From enrollment to the end of 3 months	Site, size and severity of lesion

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale	From Enrollment to the end of 3 months	Anxiety and depression evaluation among patients

Trial Locations

Locations (1)

Department of Oral Medicine and radiology, Goa Dental College and Hospital, Bambolim Goa India; 🇮🇳 Goa, Bambolim, India