| 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
|
|
|
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
|
|
|
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. |