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CTRI Number  CTRI/2026/04/108458 [Registered on: 15/04/2026] Trial Registered Prospectively
Last Modified On: 13/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Dentistry 
Study Design  Other 
Public Title of Study   Effectiveness of Two Antibacterial Gels in Improving Gum Health in Diabetic Patients: A Clinical Study. 
Scientific Title of Study   CLINICAL AND RADIOGRAPHIC EVALUATION OF EFFECT OF OXYGEN-RELEASING FORMULA GEL AND CHLORHEXIDINE GEL AS AN ADJUNCT TO NONSURGICAL THERAPY IN CONTROLLED TYPE II DIABETIC PATIENTS WITH STAGE II GRADE B PERIODONTITIS – A SPLIT MOUTH 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  Dr Achsa Annie Kurian 
Designation  Post Graduate Student 
Affiliation  Coorg Institute of Dental Sciences 
Address  Coorg Institute Dental Sciences,SH 88B, Kodagu, Virajpet, Aimangala, Karnataka 571218

Kolar
KARNATAKA
571218
India 
Phone  9535624579  
Fax    
Email  achsaann1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Achsa Annie Kurian 
Designation  Post Graduate Student 
Affiliation  Coorg Institute of Dental Sciences 
Address  Coorg Institute Dental Sciences,SH 88B, Kodagu, Virajpet, Aimangala, Karnataka 571218

Kolar
KARNATAKA
571218
India 
Phone  9535624579  
Fax    
Email  achsaann1998@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Radhika B 
Designation  Professor 
Affiliation  Coorg Institute of Dental Sciences 
Address  Coorg Institute Dental Sciences,SH 88B, Kodagu, Virajpet, Aimangala, Karnataka 571218

Kodagu
KARNATAKA
571218
India 
Phone  9742096982  
Fax    
Email  radika_b24@yahoo.co.in  
 
Source of Monetary or Material Support  
Coorg Institute of Dental Sciences, Department of Periodontics and Implantology, Kanjithanda Kushalappa Campus, Maggula, Virajpet-571218, Kodagu, Karnataka 
 
Primary Sponsor  
Name  Dr Achsa Annie Kurian 
Address  Coorg Institute of Dental Sciences, Department of Periodontics and Implantology, Kanjithanda Kushalappa Campus, Maggula, Virajpet-571218, Kodagu, Karnataka 
Type of Sponsor  Other [SELF] 
 
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 Achsa Annie Kurian  Coorg Institute of Dental Sciences  Department of Periodontics and Implantology , Room No 4, Coorg Institute of Dental Sciences, S H 88B , Kodagu, Virajpet,571218
Kodagu
KARNATAKA 		 9535624579

achsaann1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTION REVIEW BOARD, COORG INSTITUTE OF DENTAL SCIENCES  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 
Intervention  Chlorhexidine gel  Chlorhexidine gel will be applied directly into the periodontal pocket until it slightly overflows from the pocket at baseline following scaling and root planing. 
Intervention  Oxygen releasing formula gel  Oxygen releasing formula gel will be applied directly into the periodontal pocket until it slightly overflows from the pocket at baseline following scaling and root planing. 
Intervention  Placebo gel  Placebo gel will be applied directly into the periodontal pocket until it slightly overflows from the pocket at baseline following scaling and root planing. 
Comparator Agent  Scaling and root planing   Full mouth SRP and gel application will be performed at baseline following initial examination. 
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Subjects who are diagnosed with clinical Stage II periodontitis grade B and are willing to undergo treatment.
2. Patients 20 to 55 years of age
3. Patients with periodontal pocket depth less than or equal to 5mm in at least in 2 quadrants
4. A minimum of 15 teeth should remain.
5. Patients with controlled Type 2 diabetes (HbA1C less than 7),
6. Smokers - less than 10 cigarettes per day
 
 
ExclusionCriteria 
Details  1. Use of antibiotics in the past 6 months
2. Steroid or inflammatory drugs for 7 days in 3 months
3. Known allergy to the above-mentioned drugs/substances
4. Alcoholic
5. Pregnant and lactating women
6. Periodontal therapy within 6 months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of oxygen releasing formula gel and chlorhexidine gel as an adjunct to scaling and root planing on clinical parameters (Plaque Index, Gingival Index, Probing Pocket Depth, Clinical Attachment Level, and Bleeding on Probing) and radiographic outcomes (radiographic linear defect depth and defect angle) in controlled type II diabetic patients with Stage II Grade B periodontitis at baseline, 12 weeks and 24 weeks  To evaluate the efficacy of oxygen releasing formula gel and chlorhexidine gel as an adjunct to scaling and root planing on clinical parameters (Plaque Index, Gingival Index, Probing Pocket Depth, Clinical Attachment Level, and Bleeding on Probing) and radiographic outcomes (radiographic linear defect depth and defect angle) in controlled type II diabetic patients with Stage II Grade B periodontitis at baseline, 12 weeks and 24 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacy of oxygen releasing formula gel, chlorhexidine gel, placebo gel as an adjunct to scaling & root planing & scaling & root planing alone on clinical parameters & radiographic outcomes in controlled type II diabetic patients with Stage II Grade B periodontitis.  All clinical parameters will be measured at baseline, 3 months & 6 months, & radiographic evaluation will be done at baseline, 3 months & 6 months after the therapy. Gel application will be done at baseline. 
 
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   N/A 
Date of First Enrollment (India)   25/04/2026 
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="0"
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  

This split-mouth, double-blind, randomised controlled clinical trial aims to evaluate the clinical and radiographic efficacy of an oxygen-releasing formula gel and a chlorhexidine gel as adjuncts to scaling and root planing in controlled type II diabetic patients with Stage II Grade B periodontitis. A total of 30 patients will be included, with each quadrant randomly assigned to SRP alone, SRP with oxygen releasing gel, SRP with chlorhexidine gel, or SRP with placebo gel. Clinical parameters such as Plaque Index, Gingival Index, Probing Pocket Depth, Clinical Attachment Level, and Bleeding on Probing will be assessed at baseline, 3 months, and 6 months. Radiographic evaluation using standardised intraoral periapical radiographs will measure radiographic linear defect depth and defect angle at baseline and 6 months to assess bone changes. The study aims to compare the effectiveness of these adjunctive therapies in improving periodontal health and bone healing.

 
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