| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.riyaz.j@gmail.com].
- 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.
- 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 |