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CTRI Number  CTRI/2019/10/021714 [Registered on: 18/10/2019] Trial Registered Prospectively
Last Modified On: 21/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of changes in extraction socket of tooth after filling with tooth powder mixed with blood derived product 
Scientific Title of Study   Clinical, Histomorphometric and 3-Dimensional Cone Beam Computed Tomographic Analysis of Autogenous Tooth Bone Graft Mixed with Injectable Platelet Rich Fibrin for Ridge Preservation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vikender Singh 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  5th Floor, Division of Periodontics, Centre for Dental Education and Research, AIIMS

South
DELHI
110029
India 
Phone  8800798248  
Fax    
Email  vikenderyadav@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vikender Singh 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  5th Floor, Division of Periodontics, Centre for Dental Education and Research, AIIMS

South
DELHI
110029
India 
Phone  8800798248  
Fax    
Email  vikenderyadav@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vikender Singh 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  5th Floor, Division of Periodontics, Centre for Dental Education and Research, AIIMS

South
DELHI
110029
India 
Phone  8800798248  
Fax    
Email  vikenderyadav@gmail.com  
 
Source of Monetary or Material Support  
Research Section, Intramural Research Grant, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Ansari Nagar, New Delhi Pin:110029 
Type of Sponsor  Research institution and hospital 
 
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 Vikender Singh  All India Institute of Medical Sciences  5th Floor,Division of Periodontics, Centre for Dental Education and Research
South
DELHI 		 8800798248

vikenderyadav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R69||Illness, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Autogenous tooth bone graft   Extraction socket will be completely filled up to the gingival margin with Autogenous tooth bone graft by compressing the graft material without excessive force.  
Intervention  Autogenous tooth bone graft mixed with injectable platelet rich fibrin  Autogenous tooth bone graft particles will be filled in the extraction socket followed by injection of 5 ml of injectable PRF over the graft and will be left for 1 minute to coagulate.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  b) Patients who have a clinically determined need for extraction of single rooted non-molar tooth (root or crown fractures, non-restorable caries and residual roots). followed by an implant supported restoration
c) Patients who will be available for further follow up.
d) Adequate restorative space for implant-supported restoration
e) Presence of at least one tooth on each side to the tooth to be extracted.
f) ≥ 10-mm distance of alveolar bone crest from the base of the socket.
g) Root location and angulation that would be consistent with the subsequent implant placement.
 
 
ExclusionCriteria 
Details  a) Inability or anticipated failure to maintain adequate oral hygiene
b) Pregnant or lactating moth¬ers
c) Patients with other systemic conditions (uncontrolled diabetes, unstable bleeding disorders, active infectious diseases; hepatitis, tuberculosis, HIV etc.) that could affect the healing ability of wound.
d) Mental disabilities that may hinder participation.
e) Active immunosuppressive therapy, cancer therapy and/or radiation to the oral cavity within the past 6 months
f) Patients with acute dental infection of bone and ankylosed teeth.
g) Conditions/medications contraindicated for bone regeneration (e.g. methotraxate, cyclosporine A, steroids, bisphosphonates).
h) Multirooted teeth because of the potential for presence of interradicular bone that might be harvested as part of the core biopsy procedure.
i) Loss of more than 50% of buccal plate at the time of extraction
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Postextraction dimensional and histologic changes in grafted sockets  4 months 
 
Secondary Outcome  
Outcome  TimePoints 
Maximum insertion torque value during implant placement and radiographic bone density  4 months 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   16/12/2019 
Date of Study Completion (India) 08/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published. Publications which may arise: Clinical, Histomorphometric and 3-Dimensional Cone Beam Computed Tomographic Analysis of Autogenous Tooth Bone Graft Mixed with Injectable Platelet Rich Fibrin for Socket Preservation 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Replacement of missing or extracted teeth by implants in anatomically, aesthetically, and long term functional restorative positions depend on having adequate bone and soft tissue dimensions both vertically and horizontally. Tooth extraction produces resorption and remodelling of socket dimensions which reduce bone volume available for implant placement subsequently. Even immediate placement of implant into socket sites will not prevent the loss of hard tissue dimension inside the socket wall. 

Socket grafting to minimize the volume changes of socket i.e. Socket or Ridge Preservation has been reported with a number of filler materials being used, including allografts, xenografts, alloplasts, and bioactive materials such as bone morphogenetic proteins and platelet rich fibrin. Use of autologous tooth graft has gained wide popularity in last few years and has demonstrated bone regeneration in histomorphometric studies. Among the platelet derived products, injectable Platelet-rich Fibrin (iPRF) offers the characteristics of advanced PRF as a liquid. It contains high quantities of growth factors which stimulates cell proliferation and up-regulates angiogenesis. When injectable PRF is injected onto the bone graft, it gets adsorbed on the graft particles to form a cohesive mass. It may be hypothesized that a mixture of autogenous tooth bone graft and bioactive material (iPRF) may results in an increased percentage of vital bone formation.

Furthermore, the quality of augmented bone in extraction socket is the determinant of primary implant stability during implant placement and a critical factor in determining the success of dental implants. To date there is no research which has evaluated the quality of bone formation in extraction sockets grafted with ATBG mixed with iPRF and its clinical correlation with the primary implant stability. Therefore, aim of the present study is to evaluate the clinical, radiographic, and histomorphometric analysis of autogenous tooth bone graft mixed with injectable platelet rich fibrin for ridge preservation. 

 
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