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CTRI Number  CTRI/2025/09/095387 [Registered on: 24/09/2025] Trial Registered Prospectively
Last Modified On: 23/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing new therapies with regular dental cleaning procedure. 
Scientific Title of Study   Comparative evaluation of the adjunctive use of ozone therapy, antimicrobial photodynamic therapy and topical oxygen-releasing gel compared to scaling and root planing alone: a single blinded randomized controlled trial. 
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 Nidhi Anand 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Hospital, Jamnagar 
Address  112, Department of Periodontology and Implantology, Government Dental College and Hospital, Navagam Ghed, Jamnagar, Gujarat-361008 Jamnagar GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  7973227902  
Fax    
Email  anandnidhi662@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayana Patel 
Designation  Dean and Head of Department 
Affiliation  Government Dental College and Hospital, Jamnagar 
Address  112, Department of Periodontology and Implantology, Government Dental College and Hospital, Navagam Ghed, Jamnagar, Gujarat-361008 Jamnagar GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  9825191911  
Fax    
Email  drnayanagpatel@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nayana Patel 
Designation  Dean and Head of Department 
Affiliation  Government Dental College and Hospital, Jamnagar 
Address  112, Department of Periodontology and Implantology, Government Dental College and Hospital, Navagam Ghed, Jamnagar, Gujarat-361008 Jamnagar GUJARAT 361008 India


GUJARAT
361008
India 
Phone  9825191911  
Fax    
Email  drnayanagpatel@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College and Hospital, Jamnagar navagam road pincode-361008 gujarat 
 
Primary Sponsor  
Name  Dr Nidhi Anand 
Address  112, Department of Periodontology and Implantology, Government Dental College and Hospital, Navagam Ghed, Jamnagar Gujarat361008 
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 Nidhi Anand  Government Dental College and Hospital  112, Department of Periodontology and Implantology, Government Dental College and Hospital, Navagam Ghed, Jamnagar, Gujarat-361008 Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT 		 07973227902

anandnidhi662@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, M.P. SHAH MEDICAL COLLEGE AND GURU GOBINDSINGH HOSPITAL, JAMNAGAR  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  Adjunctive periodontal therapy- antimicrobial photodynamic therapy.  Group B will receive scaling and root planing followed by antimicrobial photodynamic therapy, where a special dye and laser light will be used to target bacteria. 
Intervention  Adjunctive periodontal therapy- oxygen-releasing gel.  Group C will receive scaling and root planing followed by the application of an oxygen-releasing gel. 
Intervention  Adjunctive periodontal therapy- ozone therapy.  Group A will receive scaling and root planing (SRP) followed by subgingival ozone therapy. 
Comparator Agent  Scaling and root planing alone  Group D (Control Group) will only receive Scaling and Root planing. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Participants diagnosed with moderate to severe periodontitis will be included. Eligible individuals must have at least 16 teeth, with a minimum of four teeth present in each quadrant. Participants should be between 18 and 65 years of age. 
 
ExclusionCriteria 
Details  History of antibiotic use within the previous 6 months.
History of periodontal therapy within the last 12 months.
Presence of uncontrolled systemic diseases.
Presence of respiratory diseases.
Current daily smokers.
Pregnant or lactating women.
Presence of cervical caries or cervical restorations.
Ongoing orthodontic therapy. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduced probing depth  At baseline, 6 weeks, 4 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
relative attachment level  6 weeks, 4 months, 6 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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/ Phase 4 
Date of First Enrollment (India)   21/10/2025 
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="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   Patients with moderate to severe periodontitis will be selected for this study. Randomization will be done and patients will be divided into four groups. Test Group A will receive Scaling and Root Planing (SRP) along with Ozone Therapy, test group B will receive SRP along with antimicrobial photodynamic therapy, test group C will receive SRP along with oxygen releasing gel while Control Group (D) will receive SRP alone. The parameters will be assessed at baseline, 6 weeks, 4 months and 6 months. All the adjunctive therapies will be reapplied in the respective test groups at the 4th month. The patients will be kept on follow up for a period of 6 months to evaluate reduction in probing pocket depth and gain in relative clinical attachment level. 
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