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CTRI Number  CTRI/2025/02/081311 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 25/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A COMPARATIVE EVALUATION OF OXYGEN RELEASING ORAL GEL AND HYALURONIC ACID GEL IN THE TREATMENT OF CLASS II FURCATION DEFECTS A CLINICO – RADIOGRAPHIC STUDY 
Scientific Title of Study   A COMPARATIVE EVALUATION OF OXYGEN RELEASING ORAL GEL AND 0.8 PERCENTAGE HYALURONIC ACID GEL IN THE TREATMENT OF CLASS II FURCATION DEFECTS A CLINICO – RADIOGRAPHIC 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 PAVITRA J  
Designation  POST GRADUATE STUDENT  
Affiliation  RUHS COLLEGE OF DENTAL SCIENCES 
Address  ROOM NO.6, DEPARTMENT OF PERIODONTICS, RUHS COLLEGE OF DENTAL SCIENCES, OPPOSITE TO SPACE CINEMA, SHASTRI NAGAR, JAIPUR

Jaipur
RAJASTHAN
302016
India 
Phone  8778291524  
Fax    
Email  pavitrajayakumar24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SHARMISTHA VIJAY 
Designation  SENIOR PROFESSOR 
Affiliation  RUHS COLLEGE OF DENTAL SCIENCESS 
Address  ROOM NO.6, DEPARTMENT OF PERIODONTICS, RUHS COLLEGE OF DENTAL SCIENCES, OPPOSITE TO SPACE CINEMA, SHASTRI NAGAR, JAIPUR

Jaipur
RAJASTHAN
302016
India 
Phone    
Fax    
Email  sharmisthavijay@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr. PAVITRA J 
Designation  POST GRADUATE STUDENT  
Affiliation  RUHS COLLEGE OF DENTAL SCIENCESS 
Address  ROOM NO.6, DEPARTMENT OF PERIODONTICS RUHS COLLEGE OF DENTAL SCIENCES, OPPOSITE TO SPACE CINEMA, SHASTRI NAGAR, JAIPUR

Jaipur
RAJASTHAN
302016
India 
Phone  8778291524  
Fax    
Email  pavitrajayakumar24@gmail.com  
 
Source of Monetary or Material Support  
RUHS COLLEGE OF DENTAL SCIENCES, SHASTRI NAGAR,OPPOSITE TO SPACE CINEMA,JAIPUR,INDIA PINCODE-302016 
 
Primary Sponsor  
Name  Dr PAVITRA JAYAKUMAR 
Address  ROOM NO.6, DEPARTMENT OF PERIODONTICS, RUHS COLLEGE OF DENTAL SCIENCES, SHASTRI NAGAR, JAIPUR 
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 
DRPAVITRA J   RUHS COLLEGE OF DENTAL SCIENCES  ROOM MO.6, DEPARTMENT OF PERIODONTICS, RUHS COLLEGE OF DENTAL SCIENCES, OPPOSITE TO SPACE CINEMA
Jaipur
RAJASTHAN 
8778291524

pavitrajayakumar24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RUHS COLLEGE OF DENTAL SCIENCES ETHICAL COMMITEE  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  0.8% hyaluronic acid gel  0.8% hyaluronic acid gel along with hydroxyappaitte bone graft will be paced in grade 2 furcation defect after open flap debridement once topically . 
Intervention  oxygen releasing oral gel  oxygen releasing oral along with hydroxyappatite bone graft will be placed in grade 2 furcation defect after open flap debridement once topically  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects with Chronic Periodontitis with Grade II
furcation defects with horizontal defect of atleast 3 mm in
mandibular molars.
2. Individuals with good general health and with no
systemic diseases like diabetes, bleeding disorders,
hypertension, allergic reaction, cardio-vascular diseases
were recruited to participate in this study.
3. Patients of both sexes between the age group of 30 – 50
years .
4. Teeth with functional antagonist were included. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Plaque Index (PI)
2. Gingival Index (GI)
3. Probing pocket depth (PPD).
4. Relative vertical clinical attachment level (RV-CAL)
5. Relative horizontal clinical attachment level (RH-CAL)
 
BASELINE AND 6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
1. Plaque Index (PI)
2. Gingival Index (GI) 
BASELINE ,3 & 6 MONTHS 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/03/2025 
Date of Study Completion (India) 28/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

·              Periodontitis is a complex multifactorial disease, characterized by clinical attachment loss (CAL) and formation of osseous deformities, including furcation and intra bony defects.

·              The furcation can be defined as the anatomic area of a multirooted tooth in which the roots diverge. Furcation invasion or involvement is the result of pathologic resorption of the supporting alveolar bone within a furcation, typically derived from the progression of chronic or aggressive periodontitis.

·              Molar furcation involvement is one of the most common dento-alveolar sequelae of periodontal disease. The application of a specific treatment method for furcation involvement requires a thorough understanding of tooth anatomy, etiologic factors, and the biologic basis for treatment modalities.

·              Oxygen releasing oral gel has the particularity to release oxygen at a therapeutic concentration in the affected tissues. The therapeutic effects of blue m gel are neovascularization, removal of toxins, stimulation and formation of new blood cells, increasing the production of stem cells, which leads to more rapid healing, antibacterial effect, antihistamine effect, antimycotic effect.

·              Hyaluronic acid (HA) maintains cell viability, and increases proliferation and early osteogenic differentiation.

·              HA accelerates cell differentiation and migration during tissue formation and repair process has been utilized in non-surgical periodontal therapy, peri-implantitis management, root coverage procedures, management of furcation involvement, and socket preservation.

Thus, this the kind of first study to assess the efficacy of oxygen releasing oral gel and hyaluronic acid gel in the treatment of Class II Furcation Defect. 
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