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CTRI Number  CTRI/2024/08/072547 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 16/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Evaluation of Dentinal Graft versus Platelet Rich Fibrin in Immediate Implant Placement: A Randomized Controlled Trial 
Scientific Title of Study   Clinico- Radiological Evaluation of Dentinal Graft against Platelet Rich Fibrin in Extraction Sockets with Immediate Implant Placement- A Randomized Control 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  Krishna Pampatwar 
Designation  Junior resident 
Affiliation  Datta Meghe Institute of Higher Education & Research 
Address  Department of oral and maxillofacial surgery, Ground Floor 004 SPDC Building, Sawangi

Wardha
MAHARASHTRA
442001
India 
Phone  9225560368  
Fax    
Email  krishnapampatwar308@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhushan Mundada 
Designation  Associate Professor  
Affiliation  Datta Meghe Institute of Higher Education & Research 
Address  Department of oral and maxillofacial surgery, Ground Floor 004 SPDC Building, Sawangi

Wardha
MAHARASHTRA
442001
India 
Phone  9975629137  
Fax    
Email  pbmundada18@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhushan Mundada 
Designation  Associate Professor  
Affiliation  Datta Meghe Institute of Higher Education & Research 
Address  Department of oral and maxillofacial surgery, Ground Floor 004 SPDC Building, Sawangi

Wardha
MAHARASHTRA
442001
India 
Phone  9975629137  
Fax    
Email  pbmundada18@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research Wardha India 442107 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research  
Address  Wardha India 442107 
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 
Dr Krishna Pampatwar  Sharad Pawar Dental College   Department of oral and Maxillofacial surgery (004)SPDC Building Sawangi Meghe 442001
Wardha
MAHARASHTRA 
9225560368

krishnapampatwar308@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Datta Meghe Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K084||Partial loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dentinal graft   Dentinal graft will be placed before implant placed in freshly prepared socket after extraction 
Comparator Agent  PRFM graft   PRFM graft will be placed before implant placed in freshly prepared socket after extraction 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.All patient undergoing mandibular posterior teeth extraction with immediate implant placement.
2.All patients with radiographic and clinical evidence suggestive of intact alveolar osseous architecture
3.Presence of at least 2 mm of bone beyond the root apex (Above canal).
4.Patients with type I extraction sites (four-wall socket) as per Salama and Salama (1993) classification.
 
 
ExclusionCriteria 
Details  1 All patients with underlying systemic health conditions that may impede the osseous healing cascade, such as diabetes, osteoporosis, hematologic disorders, and titanium allergies.
2.All patients with D-4 bone quality.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The success of the implant will be determined by the crestal bone changes and stability after 6 months following the use of DENTINAL GRAFT and PRFM   Assessment will be done at 3rd and 6th month 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2/ Phase 3 
Date of First Enrollment (India)   27/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  27/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Dental implant therapy has advanced significantly, providing consistent outcomes for patients. While reduced residual ridge height is common with delayed loading implants, various procedures prevent post-extraction alveolar ridge resorption. These include socket grafting materials, for bone regeneration, and instantaneous implant placement. Flapless surgery preserves bone vascularization, reducing the need for multiple surgeries and enhancing. Atraumatic extraction minimizes tissue stress, protecting remaining bone. Peri-implant voids often occur due to the horizontal gap distance between the implant and alveolar socket This study aims to evaluate the efficacy of Dentinal graft (DG) against Platelet rich fibrin matrix (PRFM) in immediate  implant procedures utilizing a two-stage protocol. This will be a prospective randomized controlled trial will be conducted, wherein patients fulfilling the inclusion criteria will be equally divided into two groups. Group A will comprise of patients in which DENTINAL graft will be placed before implant placed in freshly prepared socket after extraction‘, whereas in Group B patients will receive PRFM. After extraction socket Functional Outcomes will be measured using parameters like Clinical and Radiographic measurement The success of the implant will be determined by the crestal bone changes and stability after 6 months following the use of PRFM and DENTINAL GRAFT.

 
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