| CTRI Number |
CTRI/2025/09/094399 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study on the effect of a topical oxygen releasing gel in improving wound healing and reducing pain in patients with type 2
diabetes |
|
Scientific Title of Study
|
efficacy of topical oxygen releasing agent in enhancing soft tissue healing and reducing wound site pain in with type II Diabetes Mellitus An experimental study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr ANJANA M A |
| Designation |
Post Graduate |
| Affiliation |
PMS college of Dental Science and Research |
| Address |
Post Graduate
Department Of Oral and Maxillo Facial Surgery
PMS College of Dental Sciences and Research
Vattapara
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9074051296 |
| Fax |
|
| Email |
anjanamullathanil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yeshaswini Thelekkat |
| Designation |
Professor |
| Affiliation |
PMS College of Dental Sciences and Research |
| Address |
Department of Oral and Maxillo Facial Surgery
PMS College of Dental Sciences and Research
Vattapara
Thiruvananthapuram
KERALA
695028
India |
| Phone |
8137011166 |
| Fax |
|
| Email |
yeshas26575@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANJANA M A |
| Designation |
Post Graduate |
| Affiliation |
PMS College of Dental Sciences and Research |
| Address |
Post Graduate
Department Of Oral and Maxillo Facial Surgery
PMS College of Dental Sciences and Research
Vattapara
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9074051296 |
| Fax |
|
| Email |
anjanamullathanil@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Anjana M A |
| Address |
Department of Oral and Maxillofacial Surgery
PMS college of Dental Science and Research
Vattapara
695028
Trivandrum |
| Type of Sponsor |
Research institution and hospital |
|
|
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 ANJANA M A |
PMS college of Dental Science and Research |
Department Of Oral and Maxillo Facial Surgery
PMS College of Dental Sciences and Research
Vattapara
Thiruvananthapuram
KERALA |
09074051296
anjanamullathanil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Topical Oxygen Releasing gel |
Standard wound care as per institutional protocol |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
subjects who come under ASAII who rquires suturing after extraction in mandible
HbA1c values not exceeding 9gmpercentage |
|
| ExclusionCriteria |
| Details |
Pregnant women
Patients who are lactose intolerant |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of pain at wound site
and soft tissue healing |
3rd and 5th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Soft tissue epithelialization and Reduction in soft tissue inflammation |
3rd and 5th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Subjects satisfying the inclusion criteria and willing to give informed consent will be included in the study Soft tissue characteristics will be recorded for de epithelialization local inflammation and pain prior to the application of the topical agent The test group will receive topical application of oxygen releasing agent and other group will serve as the control group The agent will be applied over the sutured surgical wound for 2 to 3 minutes and rinsed with saline This process will be repeated for three times and patient discharged with application of a small amount of topical oxygen releasing formula over the wound site The patient will be dispensed with some Blue M gel for homecare Routine antibiotics and analgesics will be prescribed Subjects will be evaluated on day 3 and day5 using early wound healing score |