| CTRI Number |
CTRI/2025/07/091040 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Ozonated Olive Oil Plus Steroids vs Steroids alone in treating Symptomatic Oral Lichen Planus A Randomized Controlled Trial |
|
Scientific Title of Study
|
Evaluating the Efficacy Of Ozonated Olive Oil & Topical Steroids With Topical Steroid Therapy alone in patients with symptomatic OLP A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vedika Pillai |
| Designation |
Post Graduate student |
| Affiliation |
|
| Address |
Bharati Vidyapeeth Deemed to be University, Dental College and Hospital, Pune - Satara Road, Katraj- Ambegaon BK Rd, Dhankawadi
Mumbai MAHARASHTRA 411043 India |
| Phone |
9167742065 |
| Fax |
|
| Email |
vedikapillai14@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vedika Pillai |
| Designation |
Post Graduate student |
| Affiliation |
|
| Address |
Bharati Vidyapeeth Deemed to be University, Dental College and Hospital, Pune - Satara Road, Katraj- Ambegaon BK Rd, Dhankawadi t
MAHARASHTRA 411043 India |
| Phone |
9167742065 |
| Fax |
|
| Email |
vedikapillai14@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vedika Pillai |
| Designation |
Post Graduate student |
| Affiliation |
|
| Address |
Bharati Vidyapeeth Deemed to be University, Dental College and Hospital, Pune - Satara Road, Katraj- Ambegaon BK Rd, Dhankawadi
MAHARASHTRA 400059 India |
| Phone |
9167742065 |
| Fax |
|
| Email |
vedikapillai14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed to be University, Dental College and Hospital, Pune - Satara Road, Katraj- Ambegaon BK Rd, Dhankawadi , Pune -411043 |
|
|
Primary Sponsor
|
| Name |
Dr Vedika Pillai |
| Address |
Bharati Vidyapeeth Deemed to be University, Dental College and Hospital, Pune - Satara Road, Katraj- Ambegaon BK Rd, Dhankawadi , Pune -411043 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vedika Pillai |
Department Of Oral Medicine and Radiology |
Room no -14, Bharati Vidyapeeth Deemed to be University, Dental College and Hospital, Pune - Satara Road, Katraj- Ambegaon BK Rd, Dhankawadi Pune MAHARASHTRA |
9167742065
vedikapillai14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Dental College and Hospital , Pune Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L08||Infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
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 |
| Intervention |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
1)Patients having systemic disorders such as hyperthyroidism, severe anaemia and G6PD Deficiency are excluded
2)Patients who are undergoing any other treatment for oral lichen planus.
3)Patients who showed dysplasia on velscope examination
4)Patients who are not co operative with the application of topical steroid therapy and ozonated olive oil according to the instructions given will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 immunity |
Patients will be evaluated on the 7th 14th 21st 28th day and will be followed up for 2 to 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 period |
The patient will be evaluated on the 7th,14th,21st,28th,2months and 6 months during the course of the study |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 . A lottery system will be applied for the patient allocation with respect to both the groups in order to avoid bias. The study is single 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. |