- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06761001
Investigation of the Effect of I-PRF Application on Pain in Alveolitis
February 18, 2025 updated by: Gorkem Tekin, Eskisehir Osmangazi University
Literature review showed that there are no studies on the use of i-PRF in alveolitis cases.
The aim of this study was to investigate the effect of i-PRF on the treatment of alveolitis.
The hypothesis of the study was that i-PRF applied to alveolitis patients would reduce pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The present study will include 60 healthy patients over 18 years of age with alveolitis.
60 patients will be randomly divided into two groups: Control and I-PRF.
After irrigation of the sockets, no substance will be applied to the control group, and I-PRF will be applied to the study group.
Postoperative pain will be measured on the 3rd and 7th days.
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
-
Eskişehir, Turkey, 26480
- Eskisehir Osmangazi University
-
-
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:
Healthy individuals without systemic disease Patients with complete data and attending their appointments
Exclusion Criteria:
Patients who smoke Pregnant or breastfeeding female patients with bleeding disorders and diabetics Patients currently or previously using bisphosphonates or receiving radiotherapy to the jaw Patients unable to consent to participate in the study
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: I-PRF
I-PRF Application
|
After local anesthesia is injected, alveolar curettage is performed and the socket is irrigated with saline solution.
I-PRF is given to patients in the experimental group.
|
|
Active Comparator: Standard treatment
standard treatment
|
After local anesthesia is injected, alveolar curettage is performed and the socket is irrigated with saline solution.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in post-operative pain assessed: visual analog (VAS) scale
Time Frame: postoperative 3rd, and 7th days
|
VAS measured on a 10cm scale, where 0 represents no pain and 10 represents maximum pain
|
postoperative 3rd, and 7th days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Görkem TEKİN, Assist.Prof., Eskişehir Osmangazi University Faculty of Dentistry
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Uranbey O, Ayranci F. How effective are concentrated growth factor and injectable platelets in reducing complications following impacted third molar surgery? Quintessence Int. 2024 May 30;55(5):380-390. doi: 10.3290/j.qi.b5213477.
- Laforgia A, Inchingolo AD, Riccaldo L, Avantario P, Buongiorno S, Malcangi G, Bordea IR, Palermo A, Inchingolo F, Inchingolo AM, Dipalma G. The Use of Platelet-Rich Fibrin (PRF) in the Management of Dry Socket: A Systematic Review. Int J Mol Sci. 2024 Sep 19;25(18):10069. doi: 10.3390/ijms251810069.
- Sharma A, Aggarwal N, Rastogi S, Choudhury R, Tripathi S. Effectiveness of platelet-rich fibrin in the management of pain and delayed wound healing associated with established alveolar osteitis (dry socket). Eur J Dent. 2017 Oct-Dec;11(4):508-513. doi: 10.4103/ejd.ejd_346_16.
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)
October 20, 2024
Primary Completion (Actual)
February 18, 2025
Study Completion (Actual)
February 18, 2025
Study Registration Dates
First Submitted
December 30, 2024
First Submitted That Met QC Criteria
January 6, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 18, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EskisehirOU-TEKIN-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD may share with other researchers upon request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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