Oral Lichen Planus
Conditions
Keywords
Oral Lichen Planus, Neem, Triamcinolone acetonide, corticosteroid, clinical trial
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.
Interventions
DRUGNeem gel
1.5% Neem Gel in orabase formulation, twice daily application for 3 months
DRUGTriamcinolone Acetonide
0.1% oral paste to be applied twice daily for 3 months
Sponsors
Goa Dental College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Visual Analogue Scale | From enrollment to the end of 3 months | Burning sensation will be evaluated with Visual Analogue scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale | From Enrollment to the end of 3 months | Anxiety and depression evaluation among patients |
Countries
India
Outcome results
None listed