Comparing Ozonated Olive Oil Plus Steroids vs Steroids alone in treating Symptomatic Oral Lichen Planus A Randomized Controlled Trial

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2025
INTERVENTION: Intervention1: Ozonated Olive oil: Ozonated Olive oil is a natural product created by bubbling ozone gas through high quality , cold pressed olive oil for an extended period . This process saturates the oil with ozone, forming ozonides and peroxides, which gives the oil its therapeutic properties . When ozone reacts with the fatty acids in olive oil , it creates ozonides and peroxide compounds which are known for their antimicrobial, anti ‐ inflammataory and wound healing effects. The dose for ozonated olive oil is pea sized amount which is 0.25‐0.5 ml 2‐3 times a day preferably after meals and before bed Control Intervention1: Topical 0.1% triamcinalone acetonide orabase (Kenacort TM 0.1% Abbott, India): Topical 0.1% Triamcinolone acetonide in orabase is a cortocosteroid preparation commonly used in dentistry for treating inflammatory and ulcerative lesions in the mouth. It is a medium potency corticosteroid which reduces inflammation, swelling , redness, itching, immune response at the site of application . Orabase acts as protective barrier and enhances adherence to the mucosa allowing the steroid to act more effectively. The dosage is pea sized amount which is 0.25ml to be applied 2‐3 times daily after meals and at bedtime. Eating, drinking or rinsing should be avoided for at least 30 minutes after application CONDITION: Health Condition 1: L00‐L08‐ Infections of the skin and subcutaneous tissue PRIMARY OUTCOME: The primary outcome for application of ozonated olive oil results in reduction in burning sensation and pain reduction on lesion size and severity anti inflammatory effect no systemic side effects improved patient compliance resulting in non stinging , soothing nature that promotes adherence Unlike corticosteroids ozone does not suppress immunityTimepoint: Patients will be evaluated on the 7th 14th 21st 28th day and will be followed up for 2 to 4 months SECONDARY OUTCOME: To evaluate the effect of ozonated olive oil on the subjective symptoms of oral lichen planus , including pain relief, burning sensation and patient reported quality of life as well as to monitor for any adverse reactions , recurrence rate and tolerability of the treatment over the study periodTimepoint: The patient will be evaluated on the 7th,14th,21st,28th,2months and 6 months during the course of the study INCLUSION CRITERIA: 1)Patients of either gender and age 18 ‐ 60 yrs 2) Patients with clinical diagnosed symptomatic oral lichen planus 3) Patients willing to participate in the study and for follow up
Epistemonikos ID: 92b2543267c6a7d24599a3b4e517f30d22936e9b
First added on: Sep 08, 2025