| CTRI Number |
CTRI/2026/01/100068 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of blood product platelet-rich fibrin (PRF) in enhancing healing of wound after tooth removal. |
|
Scientific Title of Study
|
Efficacy of Platelet-Rich Fibrin (PRF) in Enhancing Healing of Tooth Extraction Socket: A split-mouth randomized controlled clinical trials. |
| 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 Nitesh Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Memorial Medical College and Hospital |
| Address |
Department of Dentistry,
Mahatma Gandhi Memorial Medical College and Hospital, Dimna road, Mango, Jamshedpur
Dimna road, Mango, Jamshedpur
Purbi Singhbhum
JHARKHAND
831020
India |
| Phone |
9685931544 |
| Fax |
|
| Email |
drniteshsharma@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitesh Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Memorial Medical College and Hospital |
| Address |
Department of Dentistry,
Mahatma Gandhi Memorial Medical College and Hospital, Dimna road, Mango, Jamshedpur
Dimna road, Mango, Jamshedpur
Purbi Singhbhum
JHARKHAND
831020
India |
| Phone |
9685931544 |
| Fax |
|
| Email |
drniteshsharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitesh Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Memorial Medical College and Hospital |
| Address |
Department of Dentistry,
Mahatma Gandhi Memorial Medical College and Hospital, Dimna road, Mango, Jamshedpur
Dimna road, Mango, Jamshedpur
Purbi Singhbhum
JHARKHAND
831020
India |
| Phone |
9685931544 |
| Fax |
|
| Email |
drniteshsharma@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Multi-Disciplinary Research Unit, Mahatma Gandhi Memorial Medical College and Hospital, Jamshedpur, Jharkhand |
|
|
Primary Sponsor
|
| Name |
Multi-Disciplinary Research Unit |
| Address |
Mahatma Gandhi Memorial Medical College and Hospital, Jamshedpur, Jharkhand |
| Type of Sponsor |
Government medical college |
|
|
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 Nitesh Kumar Sharma |
Mahatma Gandhi Memorial Medical College and Hospital |
Department of Dentistry, Mahatma Gandhi Memorial Medical College and Hospital, Dimna road, Mango, Jamshedpur
Purbi Singhbhum
JHARKHAND |
9685931544
drniteshsharma@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MGM Medical College Hospital, Jamshedpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non-PRF |
No PRF or any other material will be placed in tooth socket after atraumatic extraction. |
| Intervention |
Platelet-Rich Fibrin (PRF) |
The teeth to be extracted (simple extraction/closed method) on right or left side will be assigned into PRF group using computer generated randomization. After atraumatic extraction, the PRF membrane will be placed into the socket in PRF group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) Age 18 to 60 years
b) Systemically healthy individuals
c) No signs of active infection at the extraction site
d) Willingness to participate in the study/signed informed consent
|
|
| ExclusionCriteria |
| Details |
a) Smokers, diabetics, or immunocompromised individuals
b) Patients on anticoagulant or corticosteroid therapy
c) History of radiation therapy in head and neck region
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-operative soft tissue healing |
Day 1,3,7,15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post-operative pain |
Day 1,3,7,15 |
| Post-operative facial swelling |
Day 1,3,7,15 |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
15/01/2026 |
| 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="0"
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 - NO
|
|
Brief Summary
|
This study is a randomized, participant and outcome assessor blinded
clinical trial to evaluate the efficacy of Platelet-Rich Fibrin (PRF) on the
healing of tooth extraction sockets. The control sites will consist of
extraction sockets without PRF. The primary outcome measure is post-operative
soft tissue healing at the extraction sites, assessed on days 1, 3, 7, and 15.
Secondary outcome measures include postoperative pain and Post-operative
facial swelling, evaluated on days 1, 3, 7, and 15. |