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CTRI Number  CTRI/2026/03/106270 [Registered on: 16/03/2026] Trial Registered Prospectively
Last Modified On: 13/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Dentistry
Other (Specify) [Surgical gingival depigmentation]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Oxygen releasing gel vs vitamin E after gum depigmentation 
Scientific Title of Study   A comparative evaluation of oxygen releasing gel and vitamin E on post operative outcomes after surgical gingival depigmentation. A split mouth clinical study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Haripriya H R 
Designation  Post graduate student Department of periodontics 
Affiliation  Sri Hasanamba dental college and hospital 
Address  Room number 5 Department of periodontics Sri Hasanamba Dental college and hospital Vidyanagar

Hassan
KARNATAKA
573201
India 
Phone  8762482638  
Fax    
Email  haripriya.11121999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vivekananda M R 
Designation  Professor 
Affiliation  Sri Hasanamba dental college and hospital 
Address  Room number 5 Department of periodontics Sri Hasanamba Dental college and hospital Vidyanagar

Hassan
KARNATAKA
573201
India 
Phone  9980843531  
Fax    
Email  vivekcodsperio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vivekananda M R 
Designation  Professor 
Affiliation  Sri Hasanamba dental college and hospital 
Address  Room number 5 Department of periodontics Sri Hasanamba Dental college and hospital Vidyanagar


KARNATAKA
573201
India 
Phone  9980843531  
Fax    
Email  vivekcodsperio@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontics Sri Hasanamba dental college and hospital Vidyanagar Hassan Karnataka India 573201 
 
Primary Sponsor  
Name  Sri Hasanamba Dental college and hospital 
Address  Vidyanagar Hassan Karnataka 573201 
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 Haripriya H R  Sri Hasanamba Dental college and hospital  Department of periodontics Room no 5 Vidyanagar
Hassan
KARNATAKA 		 8762482638

haripriya.11121999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  participants with gingival hyperpigmentation who wants to look cosmetically appealing 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oxygen releasing gel   Topical application of oxygen releasing gel post operatively in surgical depigmentation cases for evaluating pain assessment and Dummett Gupta Oral Pigmentation Index for pigmentation evaluation and gingival healing.  
Comparator Agent  Vitamin E   Topical application of Vitamin E gel post operatively in surgical depigmentation cases for evaluating pain assessment and Dummett Gupta Oral Pigmentation Index for pigmentation evaluation and gingival healing. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1. Gingival melanin hyperpigmentation in maxillary and/ or mandibular arches.
2. Participants willing to undergo surgical depigmentation.
 
 
ExclusionCriteria 
Details  1. Participants unable/unwilling to undergo surgical procedure.
2. Participants with the habit of smoking.
3. Pregnant and lactating women.
4. Medically compromised participants.
5. Those with a history of periodontal surgery in less than 3 months.
6. Those with gingival pigmentation associated with other syndromes and lesions.
7. Hypersensitivity to Vitamin E.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in pain measured using visual analogue scale, Oral depigemntation evaluation and gingival healing.  0 and 14th and 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   20/04/2026 
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="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  

This split-mouth clinical study will evaluate and compare topical oxygen-releasing gel and Vitamin E on postoperative pain and gingival healing following surgical gingival depigmentation, using the Visual Analog Scale (VAS) and Dummett–Gupta Oral Pigmentation Index. Oxygen-releasing gel works by supplying sustained oxygen to the surgical site, enhancing cellular activity, promoting collagen formation, supporting angiogenesis, and reducing anaerobic bacterial load, thereby aiding wound healing. Vitamin E acts as an antioxidant, reducing oxidative stress, stabilizing cell membranes, and supporting epithelial regeneration and tissue repair. The study will compare their effectiveness in improving postoperative comfort and gingival healing.

 
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