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CTRI Number  CTRI/2025/04/084967 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 11/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Effects of platelet concentrate (ALB-PRF) on bone healing when placed in immediate dental implant  
Scientific Title of Study   Effects of ALB-PRF on bone formation when placed in immediate dental implant- A case control study  
Trial Acronym  ALB-PRF  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Antriksh Sharma 
Designation  Post Graduate Student 
Affiliation  ITS Dental College Hospital and Research Centre Knowledge ParkIII Greater Noida 
Address  Department of Oral and Maxillofacial Surgery Room no. 5 I.T.S Dental College Hospital and Research Centre Knowledge Park 3 Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  8716069310  
Fax    
Email  antrikshshar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashish Sharma 
Designation  Professor 
Affiliation  ITS Dental College Hospital and Research Centre Knowledge ParkIII Greater Noida 
Address  Department of Oral and Maxillofacial Surgery Room no. 5 I.T.S Dental College Hospital and Research Centre Knowledge Park 3 Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9634821713  
Fax    
Email  drashishsharma.omfs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Antriksh Sharma 
Designation  Post Graduate Student 
Affiliation  ITS Dental College Hospital and Research Centre Knowledge ParkIII Greater Noida 
Address  Department of Oral and Maxillofacial Surgery Room No.5 I.T.S Dental College Hospital and Research Centre Knowledge Park 3 Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  8716069310  
Fax    
Email  antrikshshar@gmail.com  
 
Source of Monetary or Material Support  
ITS DENTAL College Hospital and Reseach Centre Knowledge park 3, Greater Noida, uttar pradesh, India 201310 
 
Primary Sponsor  
Name  ITS DENTAL College  
Address  ITS DENTAL College Hospital and Reseach Centre 47 Knowledge park 3, Greater Noida,Uttar Pradesh,India 201310 
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 Antriksh Sharma  ITS Dental College Hospital and Research Centre  Department of Oral and Maxillofacial Surgery Room No.5 I.T.S Dental College Hospital and Research Centre Knowledge Park 3 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH 
8716069310

antrikshshar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
I.T.S Dental College Hospital and Research Centre Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z538||Procedure and treatment not carried out for other reasons,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients between 30 and 60 years of age, having a hopeless mandibular tooth indicated for extraction (due to an unrestorable fracture or a carious lesion) requiring immediate dental implant placement.
The absence of any active infection, pus discharge and bone dehiscence on buccal wall of tooth socket.
Intact socket walls.
ASA Grade I and II
 
 
ExclusionCriteria 
Details  Aggressive periodontitis
Medically compromised patients
External root resorption
Tobacco users
Pregnant women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
ALB-PRF is effective in promoting bone formation   ALB-PRF is effective in promoting bone formation in 8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
ALB-PRF is effective in enhancing implant stability   ALB-PRF is effective in enhancing implant stability in
8 weeks
 
 
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   N/A 
Date of First Enrollment (India)   30/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/04/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="1" 
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   This study helps to find the effectiveness of ALB-PRF in promoting bone formation when placed in immediate dental implants.
In dental implants osseointegration and implant stability is prime concern and to enhance these bone grafts and blood concentrates are widely used.
Albumin-enriched biomaterials provide an optimal structure for cell proliferation and show minimal reduction over time, suggesting less in vitro degradation. Studies further suggest that the association with albumin can stabilize the fibrin network’s ultrastructure. In addition, preliminary data indicate that combining denatured serum albumin significantly enhances the PRF-based scaffold, yielding an autologous, biocompatible material with the potential enhance durability and sustained action.Additionally they release higher level of growth factors which enhance their therapeutic potential.

 
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