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CTRI Number  CTRI/2024/06/069274 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 15/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Medicinal use of ozonated olive oil and triamcinolone acetonide in oral ulcers. 
Scientific Title of Study   Comparative evaluation of efficacy of topical triamcinolone and topical ozonated olive oil in management of recurrent aphthous stomatitis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shreeya Panchal 
Designation  BDS intern 
Affiliation  Datta Meghe Institute of Higher Education and Research Centre, Sawangi, Wardha, Maharashtra 
Address  Department of oral medicine and radiology, Sharad Pawar Dental College and Hospital, Sawangi, Wardha, Maharashtra

Wardha
MAHARASHTRA
442001
India 
Phone  9300901818  
Fax    
Email  panchalshreeya07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mrunal Meshram 
Designation  Assistant Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research Centre 
Address  Department of oral medicine and radiology, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research Centre, Sawangi, Wardha, Maharashtra

Wardha
MAHARASHTRA
442001
India 
Phone  9767810367  
Fax    
Email  drmrunalmeshram@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mrunal Meshram 
Designation  Assistant Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research Centre 
Address  Department of oral medicine and radiology, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research Centre, Sawangi, Wardha, Maharashtra

Wardha
MAHARASHTRA
442001
India 
Phone  9767810367  
Fax    
Email  drmrunalmeshram@gmail.com  
 
Source of Monetary or Material Support  
Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research Centre, Sawangi, Wardha, India, Pincode 442001 
 
Primary Sponsor  
Name  Shreeya Panchal 
Address  Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research Centre, Sawangi, Wardha, India, Pincode 442001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Shreeya Panchal  Datta Meghe Institute of Higher Education and Research Centre   Department of oral medicine and radiology, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research Centre, Sawangi, Wardha, Maharashtra
Wardha
MAHARASHTRA 
9300901818

panchalshreeya07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Topical ozonated olive oil  Topical ozonated olive oil in managing recurrent aphthous stomatitis will be assessed on the second, fourth, and sixth days of treatment. The evaluations will be repeated until the ulcer is completely healed. 
Comparator Agent  Topical triamcinolone acetonide  Topical triamcinolone acetonide in managing recurrent aphthous stomatitis will be assessed on the second, fourth, and sixth days of treatment. The evaluations will be repeated until the ulcer is completely healed. 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects in age group 14-70 years.
Subjects having one or more recurrent ulcers.
Subjects having duration of ulcer not more than 48 hours.
Subjects should not be on any medication for oral ulcers.
Subjects with painful ulcers causing discomfort.
Subjects should be healthy, with no systemic disease (diabetes) and immune-deficiency state. 
 
ExclusionCriteria 
Details  Patients suffering from systemic disorders which are known to cause ulcerations.
Patients who are already undergoing therapy for aphthous ulcers.
Patients presenting with chronic non-healing ulcers.
Patients reporting of ‘no pain/painless ulcer’.
Patients suffering from oral submucous fibrosis.
Pregnant women or lactating mothers.
Patient having known history of serious drug hypersensitivities.
Patients unable to attend multiple visits. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The patient will get relief from discomfort from aphthous ulcer   8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   01/07/2024 
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="0"
Months="2"
Days="0" 
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  
The study will aim to compare the efficacy of topical ozonated olive oil and topical triamcinolone acetonide in managing recurrent aphthous stomatitis (RAS). RAS, characterized by painful oral ulcers, lacks a specific cure, with treatments focused on symptom management. Corticosteroids, including triamcinolone acetonide, will be commonly used for RAS treatment due to their anti-inflammatory properties. Conversely, ozone therapy, aimed at enhancing oxygen levels and harnessing antimicrobial effects, will be gaining attention.

The sample size calculation will determine a total of 60 participants, divided equally into two groups: one treated with topical ozonated olive oil and the other with topical triamcinolone acetonide. The study will include individuals aged 16 years and above, without systemic diseases or medication for oral ulcers.

Data collection will involve assessing pain intensity using a visual analogue scale (VAS) and measuring ulcer size with a graded periodontal probe. Treatment application will occur four to five times daily until complete ulcer healing, with evaluations on the second, fourth, and sixth days.

Statistical analysis, to be conducted using SPSS version 23, will include descriptive statistics, frequency distribution, and independent sample t-tests for intergroup comparisons (p < 0.05).

The outcomes will focus on pain relief, ulcer size reduction, and healing duration. Pain intensity will be measured on a scale of 0-10, while ulcer size will be recorded at different time intervals.

In conclusion, the study will seek to provide insights into the comparative effectiveness of topical ozonated olive oil and topical triamcinolone acetonide in managing RAS. Results will contribute to understanding optimal treatment strategies for this prevalent oral condition, potentially improving patient comfort and quality of life.
 
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