- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07257328
Effect of Injectable Platelet Rich Fibrin (i-PRF) on Extraction Socket Healing: A Split-Mouth Randomized Study. ((i-PRF))
November 20, 2025 updated by: Saglik Bilimleri Universitesi
Comparison of Injectable Platelet-Rich Fibrin (i-PRF) Application and Routine Surgical Extraction on Socket Healing Using a Split-Mouth Technique.
The aim of this study is to compare extraction socket healing (SH) following surgical extraction of lower third molars (LTMs) with and without the application of injectable platelet rich fibrine (i-PRF).
A minimum of 32 participants will be included.
One mandibular third molar per participant will be randomly assigned to the control group and the contralateral tooth to the test group.
SH, gingival recession, and distal periodontal pocket depth of the adjacent second molar will be assessed, and outcomes compared between sides.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Surgical extraction of lower third molars (LTMs) is the most commonly performed procedure in oral and maxillofacial surgery (OMFS).
Healing of the extraction socket is a key outcome in oral surgery, as complications in healing may lead to delayed recovery, persistent pain, infection, and adverse events such as dry socket.
The aim of this study is to compare extraction socket healing (SH) following surgical extraction of LTMs with and without the application of injectable platelet rich fibrine (i-PRF).
For this purpose minimum 32 participants from both sexes will be included to the study.
For each participant, one LTM (right or left) will be randomly assigned to the control group and the contralateral tooth to the test group.
In the control group, the extraction socket will be irrigated with 0.9% physiological saline solution following standard extraction, whereas in the test group, the socket will be irrigated with i-PRF.
SH will be assessed on postoperative days 3 and 14, and at 6 weeks, using the Inflammatory Proliferative Remodeling (IPR) scale and the hydrogen peroxide (H₂O₂) test.
Gingival recession and the depth of the periodontal pocket at the distal aspect of the adjacent second molar will be recorded on postoperative days 7 and 14.
The outcomes will be compared between the two sides with respect to wound healing.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- University of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Individuals of both sexes Age over 18 years Non-smokers Systemically healthy (ASA I) Requiring surgical extraction of bilateral mandibular third molars
Exclusion Criteria:
Lack of consent to participate Pregnancy Smokers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control group
In the control group, routine surgical extraction will be performed, and the extraction socket will be irrigated with 0.9% physiological saline.
|
Surgical extraction of lower third molars: Impacted or difficult-to-remove lower wisdom teeth are removed using surgical techniques, involving an incision in the soft tissue and removal of bone.
|
|
Experimental: Test group
In the test group, routine surgical extraction will be performed, and the extraction socket will be irrigated with i-PRF.
|
Surgical extraction of lower third molars: Impacted or difficult-to-remove lower wisdom teeth are removed using surgical techniques, involving an incision in the soft tissue and removal of bone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of socket healing
Time Frame: 6 weeks
|
Socket healing of the extracted tooth will be evaluated by using IPR scale which allows to evaluate the healing process according to its biological phases.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2024
Primary Completion (Actual)
July 1, 2024
Study Completion (Actual)
July 31, 2024
Study Registration Dates
First Submitted
November 20, 2025
First Submitted That Met QC Criteria
November 20, 2025
First Posted (Actual)
December 2, 2025
Study Record Updates
Last Update Posted (Actual)
December 2, 2025
Last Update Submitted That Met QC Criteria
November 20, 2025
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 22-104
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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