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CTRI Number  CTRI/2025/03/083007 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 07/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   COMPARING NOVA BONE DENTAL PUTTY AND PLATELET RICH FIBRIN FOR TREATING HORIZONTAL BONY DEFECTS  
Scientific Title of Study   THE REGENERATIVE POTENTIAL OF NOVA BONE DENTAL PUTTY AND PLATELET RICH FIBRIN(PRF) IN TREATING HORIZONTAL BONY DEFECTS - A COMPARATIVE SPLIT MOUTH STUDY 
Trial Acronym  IMP,OFD,PRF 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  FATHIMA SUHARAL 
Designation  POST GRADUATE STUDENT 
Affiliation  SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE 
Address  SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE, DEPARTMENT OF PERIODONTOLOGY, CHAPURAM, SRIKAKULAM 532401.
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE, DEPARTMENT OF PERIODONTOLOGY, CHAPURAM, SRIKAKULAM 532401.
Srikakulam
ANDHRA PRADESH
532401
India 
Phone  9392346929  
Fax    
Email  fathimasuharal@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  DR ANIL KUMAR 
Designation  PROFESSOR AND HEAD OF THE DEPARTMENT 
Affiliation  DR.N.T.R UNIVERSITY OF HEALTH AND SCIENCE 
Address  SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE, CHAPURAM.
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE, CHAPURAM.
Srikakulam
ANDHRA PRADESH
532401
India 
Phone  9989570600  
Fax    
Email  anilkanc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  FATHIMA SUHARAL 
Designation  POST GRADUATE STUDENT 
Affiliation  SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE 
Address  SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE, DEPARTMENT OF PERIODONTOLOGY, CHAPURAM, SRIKAKULAM 532401.

Srikakulam
ANDHRA PRADESH
532401
India 
Phone  9392346929  
Fax    
Email  fathimasuharal@yahoo.com  
 
Source of Monetary or Material Support  
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE 
 
Primary Sponsor  
Name  FATHIMA SUHARAL 
Address  SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE, DEPARTMENT OF PERIODONTOLOGY, CHAPURAM, SRIKAKULAM 532401 
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 FATHIMA SUHARAL  SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE  SREE SAI DENTAL COLLEGE AND RESEACH INSTITUTE, DEPARTMENT OF PERIODONTOLOGY, CHAPURAM SRIKAKULAM 532401
Srikakulam
ANDHRA PRADESH 
9392346929

fathimasuharal@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE  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  INTRA MARROW PENETRATION  patients are treated with open flap debridement with intra marrow penetration and re-evaluation after 6 months 
Intervention  NOVA BONE PUTTY  patients are treated with open flap debridement with intra marrow penetration and nova bone putty and re-evaluation after 6 months  
Intervention  PLATELET RICH FIBRIN  patients are treated with open flap debridement with intra marrow penetration and platelet rich fibrin and re-evaluation after 6 months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1 Systemically healthy patients.
2 Age: 20 - 55 years.
3 Minimum of two teeth with Probing pocket depth 5mm OR more
4 Horizontal bone loss more than or equal to 6mm measuring from cemento-enamel junction (CEJ).
 
 
ExclusionCriteria 
Details  1 Medically compromised patients.
2 Teeth with grade III mobility.
3 Pregnant and lactating women.
4 Smokers.
5 Patients on medications known to interfere with periodontal tissue health and healing.
• Previous periodontal surgery on the involved teeth.
 
 
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 Blinded 
Primary Outcome  
Outcome  TimePoints 
REDUCTION IN POCKET DEPTH
CLINICAL ATTACHMENT GAIN 
BASELINE , 6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque Index
Gingival Index

 
BASELINE, 6 MONTHS 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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 4 
Date of First Enrollment (India)   28/07/2025 
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="2"
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  

     The current randomized split-mouth study consists of 15 systematically healthy patients. Patients will be chosen according to specified inclusion and exclusion criteria. Informed consent will be acquired from each patient, and subsequently, they will be randomly assigned to one of three groups. Group I patients are treated with open flap debridement with intra marrow penetration, Group II patients are treated with open flap debridement with intra marrow penetration and nova bone putty and Group III patients are treated with open flap debridement with intra marrow penetration and platelet rich fibrin.  Initially scaling and root planning will be done under local anesthesia followed by oral hygiene instructions. The patient will be recalled for periodontal surgery. 

1     The following clinical and radiographic parameters will be recorded at baseline and 6 months. 

2    Plaque Index by Sillness and Loe

3      Gingival Index - Harald Loe & John Sillness 

4       Periodontal Probing Depth  

5      Clinical attachment level 

6      To evaluate bone fill using CBCT 

       The operated site of patient will be anaesthesia. No 15 blade was used to give crevicular incision and full thickness mucoperiosteal flap will be reflected and the debridement will be done to remove granulation tissue.  Micromotor handpiece and a round carbide bur will used to make intra marrow penetration in the interdental area. The required amount of Nova Bone putty and platelet rich fibrin will be taken and placed in the defect area in Group 2 and Group 3 respectively. The patient will be recalled at 6months after surgery to evaluate clinical and radiographic parameters. 

 
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