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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  
Status 
Not Applicable 
 
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 fieldsOzone 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.

 
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