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CTRI Number  CTRI/2026/03/107168 [Registered on: 30/03/2026] Trial Registered Prospectively
Last Modified On: 21/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Radiographic evaluation of bone level,density and osseointegration around implant with and without injectable platelet rich fibrin (i-PRF) A randomized control trial 
Scientific Title of Study   Radiographic evaluation of bone level bone density and osseointegration around implant with and without injectable platelet rich fibrin (i-PRF) 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  Dr S Karthiga 
Designation  MDS 
Affiliation  Sri Venkateskwaraa Dental college..Department of periodontics (6 floor) 
Address  No 12 1st cross rathna nagar puduchery 605009
No 12 1st cross rathna nagar puduchery 605009
Pondicherry
PONDICHERRY
605009
India 
Phone  6385635821  
Fax    
Email  karthigakss93@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S.senthilnathan 
Designation  MDS (professor) 
Affiliation  Sri Venkateskwaraa Dental college..Department of periodontics(6 floor) 
Address  13-A,Pondy-villupuram min road,ariyur,puducherry-605102
13-A,Pondy-villupuram min road,ariyur,puducherry-605102
Pondicherry
PONDICHERRY
605102
India 
Phone  9443133088  
Fax    
Email  principal@svdcpondy.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr S Karthiga 
Designation  MDS 
Affiliation  Sri Venkateskwaraa Dental college..Department of periodontics(6 floor) 
Address  No 12 1st cross rathna nagar puduchery 605009
13-A,Pondy-villupuram main road,ariyur,Puducherry
Pondicherry
PONDICHERRY
605009
India 
Phone  6385635821  
Fax    
Email  karthigakss93@gmail.com  
 
Source of Monetary or Material Support  
ISP (Indian society of periodontology) Address:-no.721,phase 3B-1,mohali-160059,india 
 
Primary Sponsor  
Name  Dr S Karthiga 
Address  13A pondy villupuram main road ariyur puducherry 605102 
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 S Karthiga  sri venkateshwaraa dental college  13-A,Pondy- Villupuram Main Road, Ariyur,Puducherry...department of periodontics (6 floor)
Pondicherry
PONDICHERRY 		 06385635821

karthigakss93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
sri venkateshwaraa dental college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  people with single tooth missing in the lower back teeth region 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  injectable Platelet Rich Fibrin i-PRF  i-PRF is the biological blood product and it is collected from the person own blood. It contains lot of growth factor.And it is applied over the implant before placed in the osteotomy site.(test group only). 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Partially edentulous jaws.
without active infection or severe inflammation in the area of implant placement.
 
 
ExclusionCriteria 
Details  Smoker,drug or alcohol abuse.
History of radiotherapy in head and neck region.
Uncontrolled diabetes.
parafuctional habits.
osteoporosis,malignancies and blood dycrasias.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the radiographic evaluation of bone formation around implant with and without injectable platelet rich fibrin( i-PRF) , focusing on crestal bone level after 6 months   Secondary: To assess the osseointegration of implant (CBCT)after 6 months.
To assess the bone density around implant.
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess osseointegration of implant (CBCT) after 6 months.
To assess the bone density around implant.  		 At 6 months 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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 
Date of First Enrollment (India)   17/04/2026 
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="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - 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
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  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 - Data are available indefinitely at (Link to be included karthigakss93@gmail.com).

  6. For how long will this data be available start date provided 14-01-2028 and end date provided 14-02-2066?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

lThis study will be conducted in OPD Department of Periodontology Sri Venkateshwaraa Dental College Ariyur.

lSubjects fulfilling the inclusion criteria will be included in the study after obtaining a written informed consent.

lPatients will be randomized using computer generated sequence. SNOSE technique will be used for allocation concealment.

lTo avoid inter individual variation all the interventions will be done by the same.

lOperator and the outcome will be evaluated by the same assessor.

lIn control group Placement of implant will  be done without injectable platelet rich fibrin   

lIn Test group Placement of implant will be done with injectable platelet rich fibrin

lCBCT Radiograph was taken at before implant placement(pre operatively) and 6th month post operatively to assess the crestal bone level bone density and osseointegration around implant with or without injectable platelet rich fibrin.

 
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