FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/02/031327 [Registered on: 16/02/2021] Trial Registered Prospectively
Last Modified On: 08/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparision of treatment of bony defect with bone graft versus bone graft autologus blood product. 
Scientific Title of Study   Regenerative potential of advanced platelet rich fibrin and demineralized freeze dried bone allograft in the treatment of intrabony defects: a comparative 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  PRIYANKA KUMARI 
Designation  RESIDENT 
Affiliation  M.M. College of Dental Sciences and Research Mullana, Ambala. 
Address  Department Of Periodontology M.M. College of Dental Sciences and Research Mullana, Ambala.

Ambala
HARYANA
133207
India 
Phone  9131870427  
Fax    
Email  princesscute.2527@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SURINDER SACHDEVA 
Designation  PROFESSOR & HEAD 
Affiliation  M.M. College of Dental Sciences and Research Mullana, Ambala. 
Address  Department Of Periodontology M.M. College of Dental Sciences and Research Mullana, Ambala.

Ambala
HARYANA
133207
India 
Phone  8199980802  
Fax    
Email  sksperio@gmail.com  
 
Details of Contact Person
Public Query  
Name  SURINDER SACHDEVA 
Designation  PROFESSOR & HEAD 
Affiliation  M.M. College of Dental Sciences and Research Mullana, Ambala. 
Address  Department Of Periodontology M.M. College of Dental Sciences and Research Mullana, Ambala.

Ambala
HARYANA
133207
India 
Phone  8199980802  
Fax    
Email  sksperio@gmail.com  
 
Source of Monetary or Material Support  
M.M. College of Dental Sciences and Research Mullana, Ambala. 
 
Primary Sponsor  
Name  MM College of Dental Sciences and Research 
Address  Mullana, Ambala. 
Type of Sponsor  Private medical college 
 
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 
Priyanka Kumari  M.M. College of Dental Sciences and Research Mullana, Ambala.  Department Of Periodontology M.M. College of Dental Sciences and Research Mullana, Ambala.
Ambala
HARYANA 		 9131870427

princesscute.2527@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committe maharishi markandeshwar institute of medical sciences & research mullana, ambala  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  open flap debridement and filled with Advanced platelet rich fibrin   vertical intrabony alveolar defects will be treated with open flap debridement and filled with Advanced platelet rich fibrin prepared from patients own blood. 
Comparator Agent  open flap debridement and filled with Demineralized freeze dried bone allograft (DFDBA)  vertical intrabony alveolar defects will be treated with open flap debridement and filled with Demineralized freeze dried bone allograft (DFDBA) 
Intervention  open flap debridement and filled with Demineralized freeze dried bone allograft (DFDBA) along with Advanced platelet rich fibrin  vertical intrabony alveolar defects will be treated with open flap debridement and filled with Demineralized freeze dried bone allograft (DFDBA) along with Advanced platelet rich fibrin 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients with chronic periodontitis exhibiting intrabony defects. 
 
ExclusionCriteria 
Details  Patients with contraindication to periodontal surgery & local anesthesia.
Any systemic disease affecting the bone density and outcome of periodontal therapy.
Smokers, alcoholics, and patients with other adverse habits.
Pregnant, nursing and menopausal women.
Any known allergy/ hypersensitivity to any product used in this study.
Patients on long-term systemic therapy (antibiotics, anti-inflammatory bisphosphonates, hormonal replacement therapy and any other), taking any drug known to have periodontal implications that may interfere with wound healing.
Patients taking any anti-platelet and anticoagulant medication.
Patients who have undergone periodontal treatment within a period of past 1 year.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
radiographic bone fill  baseline,6 months 
 
Secondary Outcome  
Outcome  TimePoints 
probing pocket depth  baseline,6 months 
clinical attachment level  baseline,6 months 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   24/02/2021 
Date of Study Completion (India) 08/11/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The primary clinical features of periodontitis are attachment loss, alveolar bone loss, pocket formation, gingival recession, tooth mobility and/or tooth migration. Angular bone loss leads to formation of intrabony defects. Conventional treatment such as Open Flap Debridement (OFD) often results in healing by long junctional epithelium and has very little potential in regeneration of periodontal tissues. Demineralized Freeze-Dried Bone Allograft (DFDBA) has the capacity to induce bone formation presumably due to exposure of Bone Morphogenetic Proteins (BMPs) and is considered to be Osteoinductive. Platelet Rich Fibrin (PRF) was first made by Choukroun et al.8 PRF is an autologous, inexpensive and regenerative biomaterial. It contains various growth factors released by platelets and matrix proteins. changing the centrifugation protocol by decreasing speed and increasing centrifugation time (1500 rpm,14 minutes) leads to formation of a different form of fibrin known as Advanced-Platelet Rich Fibrin(A-PRF). Knowing the role of A-PRF and DFDBA in regeneration, the present study is an attempt to evaluate and compare the regenerative potential of A-PRF and DFDBA in the treatment of intrabony defects.
 
Close