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CTRI Number  CTRI/2026/01/102178 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 16/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare bone changes around dental implants placed using two different drilling techniques, with or without platelet-rich fibrin, in patients requiring dental implants. 
Scientific Title of Study   COMPARATIVE EVALUATION OF CRESTAL BONE LEVEL OF DENTAL IMPLANT PLACED USING OSSEODENSIFYING BUR WITH OR WITHOUT INJECTABLE-PLATELET RICH FIBRIN:AN IN VIVO STUDY 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Garima Patel 
Designation  Post Graduate Student 
Affiliation  Government Dental College Raipur (C.G) 
Address  Room no 317 Government Dental Girls Hostel near rajbandha maidan raipur(C.G)

Raipur
CHHATTISGARH
492001
India 
Phone  9131331771  
Fax    
Email  drgarimapatel@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Deepesh Kumar Gupta 
Designation  Prof and Head,department of prosthodontics,Government Dental College Raipur(C.G) 
Affiliation   
Address  C/183 Tagore Nagar Raipur(C.G)

Raipur
CHHATTISGARH
492001
India 
Phone  9399091741  
Fax    
Email  dr_deepesh25@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Garima Patel 
Designation  Post Graduate Student 
Affiliation  Government Dental College Raipur (C.G) 
Address  Room no 317 Government Dental girls hostel near rajbandha maidan Raipur(C.G)

Raipur
CHHATTISGARH
492001
India 
Phone  9131331771  
Fax    
Email  drgarimapatel@gmail.com  
 
Source of Monetary or Material Support  
Garima Patel,Government Dental College Raipur(C.G) 492001 
 
Primary Sponsor  
Name  Garima Patel 
Address  Government Dental College Raipur(C.G) 492001 
Type of Sponsor  Other [self] 
 
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 Garima Patel  Governmet dental College Raipur(C.G)  Department of Oral and maxillofacial Prosthodontics and Implantology, Room no 3,Government Dental Colege, near rajbandha maidan Raipur 492001(C.G)
Raipur
CHHATTISGARH 		 09131331771

drgarimapatel@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Dental College Raipur (CG)Institutional ethics committe(human studies)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Osseodensification with Injectable Platelet Rich Fibrin  Dental implant placement using the allocated drilling protocol, with injectable platelet-rich fibrin, will be performed in one surgical session. Injectable platelet-rich fibrin will be prepared and applied during the same visit. Total duration of the intervention per participant: approximately 45–60 minutes. 
Comparator Agent  Osseodensification without Injectable Platelet Rich Fibrin  Dental implant placement using osseodensifying bur technique without the use of injectable platelet rich fibrin. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Systemically healthy partially edentulous patients requiring dental implant placement in the posterior maxilla or mandible. Patients having adequate bone volume for implant placement without the need for additional bone augmentation procedures. Patients willing to participate and provide written informed consent.
 
 
ExclusionCriteria 
Details  Patients with systemic diseases affecting bone metabolism. Patients with uncontrolled diabetes mellitus, bleeding disorders, or immunocompromised conditions. Patients with active periodontal infection at the implant site. Smokers and tobacco users. Pregnant or lactating women. Patients requiring bone grafting or sinus lift procedures at the implant site.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in crestal bone level around dental implants placed using osseodensifying bur with and without injectable platelet rich fibrin.
 		 Baseline (immediately after implant placement), 1 month, 3 months, and 6 months postoperatively.

 
 
Secondary Outcome  
Outcome  TimePoints 
Radiographic assessment of peri implant bone healing around dental implants placed using osseodensifying bur with and without injectable platelet rich fibrin.
 		 Baseline (immediately after implant placement), 1 month, 3 months, and 6 months postoperatively.
 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   07/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 07-03-2027 and end date provided 07-03-2033?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 This randomized controlled clinical trial aims to compare crestal bone level changes around dental implants placed using osseodensifying burs with or without injectable platelet-rich fibrin (i-PRF). The study evaluates whether the adjunctive use of i-PRF improves peri-implant bone preservation and promotes better osseointegration. Radiographic assessment will be performed at baseline, immediately postoperatively, and at follow-up intervals of 1,3, 6months. The findings are expected to inform optimal implant site preparation techniques and enhance long-term implant stability. 
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