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CTRI Number  CTRI/2026/03/106160 [Registered on: 13/03/2026] Trial Registered Prospectively
Last Modified On: 13/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study Comparing the Healing of Dental Implants With and Without i-PRF Coating in the Lower Back Jaw Region 
Scientific Title of Study   Comparative Evaluation Of Clinical Outcomes Between Dental Implants Coated With And Without Injectable Platelet Rich Fibrin In Posterior Mandibular Edentulous Region – A Randomised 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  Mohamed Riyaz J 
Designation  Post graduate Student  
Affiliation  Tamil Nadu Government Dental College and Hospital 
Address  Room No: 401, 4th floor, Department of Periodontics,Tamil Nadu Government Dental college and Hospital, No 1, TNPSC Road,Park Town, Chennai

Chennai
TAMIL NADU
600003
India 
Phone  8807986455  
Fax    
Email  dr.riyaz.j@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jaishree Tukaram Kshirsagar 
Designation  Head of the department and Professor  
Affiliation  Tamil Nadu Government Dental College and Hospital  
Address  Room no:401,4th floor, Department of Perodontics,Tamil Nadu Government Dental College And Hospital, No. 1, TNPSC Road, Park town, Chennai

Chennai
TAMIL NADU
600003
India 
Phone  944919606  
Fax    
Email  ktjaishree@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jaishree Tukaram Kshirsagar 
Designation  Head of the department and Professor  
Affiliation  Tamil Nadu Government Dental College and Hospital  
Address  Room no: 401, 4th floor, Department of Periodontics,Tamil Nadu Government Dental College and Hospital,No. 1, TNPSC Road, Park town, Chennai

Chennai
TAMIL NADU
600003
India 
Phone  944919606  
Fax    
Email  ktjaishree@gmail.com  
 
Source of Monetary or Material Support  
Indian Society of Periodontology and implantology,no 721, Phase 3B-1, Mohali - 160059, India  
 
Primary Sponsor  
Name  Mohamed Riyaz J 
Address  No. 31/15, Nethaji Street, Saidapet, Chennai- 600015,Tamil Nadu, India 
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 
Mohamed Riyaz J  Tamil Nadu Government Dental College And Hospital   Department Of Periodontics, Room no:401, 4th floor, Tamil Nadu Government Dental College and Hospital, no 1, TNPSC Road, Park Town, Chennai
Chennai
TAMIL NADU 
8807986455

dr.riyaz.j@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICAL COMMITTEE   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 
Comparator Agent  Surgical placement of SLA Dental implants   SLA implants will be placed in the edentulous site of posterior mandible region . Each patient patient will be followed up till 12 weeks  
Intervention  Surgical placement of SLA dental implants coated with I-PRF  I-prf will be prepared from patients’ blood and it’ll be coated on the SLA dental implants. This coated implants will be placed in edentulous site of posterior mandible region. Each patient patient will be followed up till 12 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients with edentulous region in mandibular posterior posterior region.
Patient who want Implant processes in their edentulous region.
Patient with adequate height and width in posterior region for Implant placement .
systematically healthy patients .
patients with the ability to maintain oral hygiene .
patients who are willing for voluntary participation and have signed inform consent 
 
ExclusionCriteria 
Details  Patients who have received periodontal flap or regenerative therapy within the past one year
Patients with para functional habits and Bruxism
Patients who demonstrate poor hygiene maintenance
Patients with known systemic diseases, metabolic disorders
Patients under medication known to affect the outcome of the periodontic therapy
Patients under any medication that alters bone morphology
Patients using any form of tobacco
Patients who are alcoholics
Pregnant and lactating women
Patient with known allergies
Patients undergoing radiation therapy or history of radiation within the last two years 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To measure and compare Implant stability quotient  week 0, week 1, week 6, week 12 
 
Secondary Outcome  
Outcome  TimePoints 
to evaluate width of keratinised gingiva   12 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/04/2026 
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="6"
Days="0" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 - Proposals should be directed to [dr.riyaz.j@gmail.com].

  6. For how long will this data be available start date provided 13-03-2026 and end date provided 13-03-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
Dental implant success largely depends on rapid and stable osseointegration between the implant surface and surrounding bone. Various biological modifications have been explored to enhance early implant healing and implant stability. Injectable platelet-rich fibrin (i-PRF) is an autologous platelet concentrate rich in platelets, leukocytes, and growth factors that promote angiogenesis, osteogenesis, and tissue regeneration. The i-prf is prepared by drawing 10 ml of patient’s blood and centifuging at 700rpm for 3 minutes

Coating dental implants with i-PRF prior to placement may create a biologically active fibrin matrix on the implant surface that facilitates enhanced cellular adhesion, growth factor release, and early bone formation at the implant–bone interface. This may improve early implant stability and potentially enhance the osseointegration process.

The present study will be conducted as a randomized controlled clinical trial involving 20 participants requiring dental implant placement, who will be randomly allocated into two groups (10 participants in each group). The test group will receive implants coated with i-PRF prior to placement, while the control group will receive implants placed using the conventional protocol without i-PRF coating.

The primary outcome measure will be implant stability quotient (ISQ) assessed using resonance frequency analysis at baseline (week 0), week 1, week 6, and week 12 following implant placement. The secondary outcome measure will be the width of keratinized gingiva around the implant site, measured clinically by applying iodine solution and meausred in millimeters using a periodontal probe.

The inclusion criteria includes Patients with edentulous region in mandibular posterior posterior region. 
Patient who want Implant processes in their edentulous region.
Patient with adequate height and width in posterior region for Implant placement .
systematically healthy  patients .
patients with the ability to maintain oral hygiene  .
patients who are willing for voluntary participation and have signed inform consent

the exclusion criteria includes Patients who have received periodontal flap or regenerative therapy within the past one year
Patients with para functional habits and Bruxism
Patients who demonstrate poor hygiene maintenance
Patients with known systemic diseases, metabolic disorders
Patients under medication known to affect the outcome of the periodontic therapy
Patients under any medication that alters bone morphology
Patients using any form of tobacco
Patients who are alcoholics
Pregnant and lactating women
Patient with known allergies
Patients undergoing radiation therapy or history of radiation within the last two years

The results of this study aim to evaluate whether i-PRF coating of implant surfaces can improve early implant stability and peri-implant soft tissue parameters, thereby contributing to improved clinical outcomes in implant therapy
 
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