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CTRI Number  CTRI/2025/11/097538 [Registered on: 17/11/2025] Trial Registered Prospectively
Last Modified On: 15/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Other (Specify) [Topical oxygen therapy (oxygen-releasing gel for oral mucosal healing)]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Topical Oxygen Gel on Healing of Mouth Sores 
Scientific Title of Study   Topical oxygen therapy as a novel strategy to treat oral mucosal lesion. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  J Nithya devi 
Designation  MDS-Oral Medicine and Radiology 
Affiliation  Karpaga Vinayaga Institute of dental sciences 
Address  Karpaga Vinayaga Institute of Dental Sciences Department of Oral Medicine and Radiology,Room no:4,Ground floor,Chinnakolambakkam,Palayanoor Post,Madhuranthagam Taluk,Chengalpattu.

Kancheepuram
TAMIL NADU
603308
India 
Phone  8667612642  
Fax    
Email  nithyadevi15436@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  J Nithya devi 
Designation  MDS-Oral Medicine and Radiology 
Affiliation  Karpaga Vinayaga Institute of dental sciences 
Address  Karpaga Vinayaga Institute of Dental Sciences Department of Oral Medicine and Radiology,Room no:4,Ground floor,Chinnakolambakkam,Palayanoor Post,Madhuranthagam Taluk,Chengalpattu.

Kancheepuram
TAMIL NADU
603308
India 
Phone  8667612642  
Fax    
Email  nithyadevi15436@gmail.com  
 
Details of Contact Person
Public Query  
Name  J Nithya devi 
Designation  MDS-Oral Medicine and Radiology 
Affiliation  Karpaga Vinayaga Institute of dental sciences 
Address  Karpaga Vinayaga Institute of Dental Sciences Department of Oral Medicine and Radiology,Room no:4,Ground floor,Chinnakolambakkam,Palayanoor Post,Madhuranthagam Taluk,Chengalpattu.

Kancheepuram
TAMIL NADU
603308
India 
Phone  8667612642  
Fax    
Email  nithyadevi15436@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr J Nithya devi 
Address  Room no:4,Ground floor,Department of Oral Medicine and Radiology, Karpaga Vinayaga Institute of Dental Sciences,Chinnakolambakkam,Palayanoor Post,Madhuranthagam Taluk,Chengalpattu-603308. 
Type of Sponsor  Research institution and hospital 
 
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 J Nithya devi  Karpaga Vinayaga Institute of Dental Sciences  Room no:4,Ground floor,Department of Oral Medicine and Radiology,Karpaga Vinayaga Institute of Dental Sciences,Chinnakolambakkam,Palayanoor Post,Madhuranthagam Taluk,Chengalpattu-603308.
Kancheepuram
TAMIL NADU 		 08667612642

nithyadevi15436@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
karpaga vinayaga institute of dental sciences Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z000||Encounter for general adult medical examination,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Kenacort® 0.1% oral gel (triamcinolone acetonide)  Kenacort® oral gel containing triamcinolone acetonide 0.1% w/w will be applied topically over the oral mucosal lesion using a sterile applicator, twice daily after meals for 21 days, or until complete healing is achieved, whichever occurs first. Participants will be advised to avoid eating or drinking for 30 minutes post-application. 
Intervention  Topical Oxygen Therapy (Oxygen-releasing gel applied to oral mucosa)  Topical Oxygen Therapy – An oxygen-releasing gel formulation applied locally to the affected oral mucosal area. The gel delivers active oxygen directly to the lesion site, enhancing tissue oxygenation, promoting angiogenesis, and accelerating epithelial healing. Participants will apply a thin layer of the gel topically twice daily for 21 days or until complete healing, whichever occurs first. The intervention will be administered under standard oral hygiene conditions and monitored for clinical healing, pain reduction, and adverse effects. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients aged 18 years and above.
2. Individuals presenting with clinically diagnosed recurrent aphthous stomatitis
3. Patients with no systemic conditions that may interfere with wound healing (e.g.,
uncontrolled diabetes, immunosuppressive disorders). 
 
ExclusionCriteria 
Details  1. Patients below 18 years of age.
2. Presence of systemic diseases that can impair wound healing (e.g., uncontrolled
diabetes, immunodeficiency, autoimmune disorders).
3. Patients with any allergic, malignant or potentially malignant oral lesions.
4. Pregnant or lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is the rate and extent of oral mucosal healing following the intervention, assessed through clinical evaluation of lesion size, tissue appearance, and symptom relief.Assessments will be conducted at baseline (Day 0), weekly during the initial 3 weeks, and then at 1, 3, 6, 9, and 12 months to monitor long-term healing, recurrence, and sustained treatment effectiveness.  Baseline (Day 0): Before starting the intervention Week 1 (Day 7): Early assessment of healing progress Week 2 (Day 14): Mid-point assessment Week 3 (Day 21): Final assessment of complete healing provide more details 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in pain intensity (VAS 0–10)
% reduction in lesion surface area from baseline;
Time to complete clinical healing (days);
% of participants requiring rescue analgesic medication;
Incidence of local adverse events (irritation, burning, allergy);



 		 Day 3, Day 7, Day 14, Day 21
Day 7, Day 14, Day 21
Up to Day 21
Day 21


 
 
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)   10/12/2025 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nithyadevi15436@gmail.com].

  6. For how long will this data be available start date provided 25-11-2025 and end date provided 25-10-2026?
    Response (Others) -  Data will be available from November 25, 2025 to October 25, 2026.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   oral mucosal lesions such as ulcers,traumatic injuries,and inflammatory conditions often impair oral function and quality of life.adequate oxygen supply is essential for epithelial regeneration and wound healing.this randomized controlled,open-label clinical trial aims to evaluate the efficacy and safety of topical oxygen therapy in enhancing the healing of oral mucosal lesions compared wit standard care.participants will receive either topical oxygen gel apply twice daily or conventional treatment.outcomes include clinical healing rate,reduction in pain,and improvement in lesion size over a 21-day period.the study seeks to establish topical oxygen therapy as a safe,non-invasive and effective adjunct in prompting oral mucosal repair. 
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