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
|
|
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
|
|
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.
|