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CTRI Number  CTRI/2026/03/105269 [Registered on: 03/03/2026] Trial Registered Prospectively
Last Modified On: 20/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The study compares two antimicrobial gels used along with deep cleaning in patients with gum disease 
Scientific Title of Study   A comparative evaluation of oxygen releasing formula and chlorhexidine gel as an adjunct to scaling and root planing in the management of patients with stage II grade A periodontitis. A clinico microbiology 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

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

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 Hassan

Hassan
KARNATAKA
573201
India 
Phone  9980843531  
Fax    
Email  vivekcodsperio@gmail.com  
 
Source of Monetary or Material Support  
Dept 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  Room No 5 Department of Periodontics
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 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chlorhexidine gel  Chlorhexidine is a bisbiguanide compound which is considered as gold standard for plaque control. Here this gel is used as a local drug delivery agent in patients with Stage II Grade A periodontitis after Scaling and root planing.  
Intervention  Oxygen releasing gel  Evaluation of Oxygen releasing gel as a local drug delivery agent clinically and micro biologically in patients with Stage II Grade A periodontitis after scaling and root planing. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Subjects with Stage II grade A periodontitis.
2. Probing pocket depth less than or equal to 5mm, with minimal bone loss in the past five years.
3. Subjects with a minimum of 20 teeth and at least two periodontal pockets.
4. Subjects with clinical attachment loss of 3 to 4mm.
 
 
ExclusionCriteria 
Details  1. Prior or current antibiotic therapy.
2. Medication inducing gingival enlargement.
3. Pregnant or lactating women.
4. Subjects with the habit of tobacco chewing and smoking.
5. Immunocompromised subjects.
6. Subjects with any systemic diseases.
 
 
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 of clinical signs like Gingival index, Modified sulcus bleeding index, probing pocket depth and Clinical attachment level.  0 and 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in colony forming units of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans.  0 and 30th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   17/03/2026 
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="0"
Months="0"
Days="30" 
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 - YES
  1. What data in particular will be shared?
    Response (Others) -  some clinical findings only

  2. What additional supporting information will be shared?
    Response (Others) -  any thing which is unusual
  3. Who will be able to view these files?
    Response (Others) -  only scientific researchers

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [haripriya.11121999@gmail.com].

  6. For how long will this data be available start date provided 03-03-2026 and end date provided 13-01-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study evaluates the comparative efficacy of the commercially available oxygen releasing gel and chlorhexidine gel as local drug delivery agents in patients with Stage II Grade A periodontitis. The oxygen releasing gel exerts its antimicrobial effect by releasing active oxygen into the periodontal pocket, creating an unfavorable environment for anaerobic periodontal pathogens and supports wound healing, while chlorhexidine gel acts as a broad spectrum antimicrobial with proven substantivity against periodontal microorganisms. Clinical parameters like gingival index, modified sulcus bleeding index, probing pocket depth and clinical attachment level will be analysed along with micro biological analysis of colony forming units of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans at baseline that is 0th day and 30 days post treatment.

 
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