- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07359131
Postoperative Assessment of Platelet-Rich Plasma and Platelet-Rich Fibrin in Temporomandibular Joint Surgery
Postoperative Assessment in TMJ Surgery: A Comparison of the Efficacy of Intraoperative Platelet-Rich Plasma and Platelet-Rich Fibrin Injections
The goal of this observational study is to evaluate postoperative outcomes following temporomandibular joint (TMJ) surgery and to compare the effectiveness of intraoperative platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) injections in patients with temporomandibular joint disorders.
The study includes adult patients who underwent TMJ surgery and received either PRP or PRF intraoperatively. The main questions this study aims to answer are:
Whether intraoperative PRP or PRF injection is associated with differences in postoperative pain intensity and recovery.
Whether PRP and PRF differ in their effects on postoperative jaw function, including maximum mouth opening and joint symptoms.
If there is a comparison group: Researchers will compare patients who received intraoperative PRP with those who received intraoperative PRF to assess differences in postoperative pain, functional outcomes, and joint-related symptoms.
Participants will:
Have their existing medical records reviewed retrospectively.
Provide postoperative outcome data derived from routine clinical follow-up, with no prospective recruitment or intervention.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jingping Wang, MD PhD
- Phone Number: 6179369136
- Email: jwang23@mgh.harvard.edu
Study Locations
-
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Massachusetts
-
Boston, Massachusetts, United States, 02114
- Meikun Wang
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients aged 18 to 75 years (inclusive)
Underwent unilateral or bilateral temporomandibular joint (TMJ) arthroscopy
Received intraoperative platelet-rich plasma (PRP) or platelet-rich fibrin (PRF) injection during TMJ arthroscopy
Exclusion Criteria:
Age younger than 18 years or older than 75 years
Did not undergo TMJ arthroscopy
Did not receive intraoperative PRP or PRF injection
Incomplete clinical or follow-up data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Group 1 - Platelet-Rich Plasma injection therapy group
Patients who received Platelet-Rich Plasma injections during surgery.
|
|
Group 2 - Platelet-Rich Fibrin injection therapy group
Patients who are receiving Platelet-Rich Fibrin injections during surgery.
|
|
Group 3 - non injection therapy group
Patients who are not receiving Platelet-Rich Plasma nor Platelet-Rich Fibrin injections during surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: from baseline to 6 months post-surgery.
|
The primary endpoint of the study is the change in pain intensity from baseline to 6 months post-surgery.
|
from baseline to 6 months post-surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
maximum unassisted opening (MMO)
Time Frame: baseline and various follow-up times in 6 months.
|
collect data about maximum unassisted opening (MMO)
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baseline and various follow-up times in 6 months.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024P003298
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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