Evaluating the Efficacy Of Ozonated Olive Oil & Topical Steroids With Topical Steroid Therapy alone in patients with symptomatic OLP A Randomized Controlled Trial

Oral lichen planus (OLP) is a Tcell mediated chronic inflammatory disease of the oral mucosa. Although exact etiology of OLP is not known, in most cases a multifactorial process is considered which involves genetic, psychological and infectious factors .OLP is generally observed bilaterally or symmetrically on the buccal mucosa, tongue, labial mucosa and gingiva. Multiple and various therapeutic approaches have been discussed in the management of OLP. As there is an alteration in disease activity, the use of a definitive therapeutic modality is challenging. Various available treatment options for management of OLP include intralesional and systemic corticosteroids which are mainly utilised but the outcomes are yet not  frequently satisfactory. Ozone therapy has gained a prominent consideration in the medical and dental fields. Ozone is a triatomic gaseous molecule, consisting of three oxygen atoms. It is a potent oxidiser and has the ability to oxidise any biological entity. Medical-grade ozone is essentially composed of 0.1 – 5% ozone & 95-99.6% pure oxygen & in dentistry it has been used either as a gas, water or oil to treat various conditions. Ozone has no irritating effect on tissues. Ozone therapy increases the oxygen production to the tissues, inhibits lipid peroxidation & activates the antioxidant system in the lesion . Ozone reactivates the immune system through macrophage activation and cytokines release which in turn boost immune system which makes it useful in patients with low immune status and immunodeficiency. Therefore, this study is planned to evaluate the efficacy of ozonated olive oil in the treatment of symptomatic oral lichen planus in comparison with the traditional steroid Triamcinolone acetonide.The study group will be divided into two groups where Group A will be the intervention group and Group B will be the control group.

GROUP A – 35 patients of Clinically confirmed Symptomatic Oral Lichen Planus will be treated with topical steroid therapy plus Ozonated olive oil. ( Intervention Group.)

GROUP B - 35 patients of Clinically confirmed Symptomatic Oral Lichen Planus will be treated with topical steroid therapy.( Control Group)

The study will consist of 70 patients who come to the department of Oral Medicine and Radiology within the age group of 18- 60 years of either gender.

Those patients with clinically proven Oral lichen Planus will be selected for the study. They would be provided with detailed information sheet about  proposed research project.(Only clinically symptomatic patients will be

selected  for the study)

1-  After obtaining written informed consent from all the patients.

2-  Velscope examination will be performed in order to check for the dysplastic changes . Patients showing no dysplastic changes will be included in the study.

3-  Patients with dysplastic changes on velscope will be sent for biopsy and standard protocol will be done.

4- Block Randomization method will be implicated where the sample size will be equally distributed according to age and gender . Alottery system will be applied for the patient allocation with respect to both the groups in order to avoid bias.

The study issingle blinded as after that parameters like pain, burning sensation, size and site of the lesion and period of recurrence will be noted down by the co-investigator in order to avoid the bias in the pre-designed case proforma.

The parameters involved will be :- Pain, Burning sensation and size of the lesion

**FOR GROUP A-**Group A patients would be treated by combination therapy that includes

Topical  0.1% triamcinalone acetonide oral base (Kenacort TM 0.1% Abbott, India) ( apply 5 times on affected area for 28 days / till lesion heals whichever is earlier)Ozonated olive oil (apply 3 times on affected area for 28 days / till lesion heals whichever is earlier)

For each participant initial assessment (baseline) and periodic assessment (active phase and follow up phase) will be recorded. In initial assessment (Day 0) detailed information will be obtained through personal interview and clinical examination , after obtaining informed consent and entering all the data in case proforma by Co-investigator. Intervention will be started immediately from a Day 0 after noting down all the clinical parameters. Instructions will be given to the patient regarding the application of the ozonated olive oil. The patient will be asked to wipe the area of lesion with the help of sterilize cotton then take three drops of oil on clean finger and apply over the lesion and massage for  2 minutes thrice daily . The patient will be advised not to eat or drink anything for half an hour and then will be asked to gargle with warm water.  After an interval, patient will be asked to apply the pea size of paste steroid topically Kenacort  (0.1% triamcinalone acetonide) 5 times daily over the lesion and massage for 2-3 minutes, then leave for 10 minutes. Patient will be instructed not to swallow, rinse or eat anything for 10 minutes, after which they can rinse their mouth with water. Patient will be recalled on Day 7 (1st recall) and all the clinical parameters will be recorded. The active phase lasts for 28 days or till the lesion heals, during which outcomes will be assessed  by the Co-investigator on Day 0, Day 7, Day 14, Day 21 and Day 28. During the course of the study, patients who achieve complete clinical resolution of the lesions will be advised to stop the therapy. These applications will be done till the lesion subsides, to a maximum of 28 days duration. Also, such patients will be follow up for a period of 2 to 6 months for any recurrence. Those patients who have not achieved complete clinical resolution of the lesions during active phase will be removed out from the study and further treatment will be done according to the standard protocol.

**FOR GROUP B -**Group B patients would be treated by topical steroid therapy. The patient will be asked to apply the pea size of paste steroid topically Kenacort  (0.1% triamcinalone acetonide) 5 times daily over the lesion and massage for 2-3 minutes, then leave for 10 minutes. Patient will be instructed not to swallow, rinse or eat anything for 10 minutes, after which they can rinse their mouth with water. Patient will be recalled on Day 7 (1st recall) and all the clinical parameters will be recorded. The active phase lasts for 28 days or till the lesion heals, during which outcomes will be assessed  by the Co-investigator on Day 0, on Day 7, Day 14, Day 21 and Day 28. During the course of the study, patients who achieve complete clinical resolution of the lesions will be advised to stop the therapy. These applications will be done till the lesion subsides, to a maximum of 28 days duration. Also, such patients will be follow up for a period of 2 to 6 months for any recurrence. Those patients who have not achieved complete clinical resolution of the lesions during active phase will be removed out from the study and further treatment will be done according to the standard protocol.