Postoperative Assessment of Platelet-Rich Plasma and Plat... | NCT07359131

Studies
Postoperative Assessment of Platelet-Rich Plasma and Platelet-Rich Fibrin in Temporomandibular Joint Surgery

NCT07359131

Sponsor

Jingping Wang, MD, Ph.D.

Status

Not yet recruiting

Last Update Posted

Jun 9, 2026Actual

Enrollment

700Estimated

Phase

Not provided

Conditions

Temporomandibular Joint Disorders

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2026Estimated

Primary Completion Date

Oct 31, 2027Estimated

Completion Date

Dec 5, 2027Estimated

First Submitted Date

Jan 14, 2026

First Submission Date that Met QC Criteria

Jan 14, 2026

First Posted Date

Jan 22, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2026

Last Update Posted Date

Jun 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

700Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain intensity	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.

Secondary Outcomes

Measure	Description	Time Frame
maximum unassisted opening (MMO)	collect data about maximum unassisted opening (MMO)	baseline and various follow-up times in 6 months.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

The study population consists of adult patients aged 18 to 75 years who underwent unilateral or bilateral temporomandibular joint arthroscopy at a single institution. All patients received intraoperative intra-articular injection of platelet-rich plasma (PRP) or platelet-rich fibrin (PRF) as part of routine clinical care. This is a retrospective observational study based on review of existing medical records, with no prospective recruitment or intervention.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Jingping Wang, MD PhD	Contact	6179369136		jwang23@mgh.harvard.edu

Facility	Status	City	State	ZIP	Country	Contacts
Meikun Wang		Boston	Massachusetts	02114	United States

Condition Browse Module

MeSH Terms

ID	Term
D013705	Temporomandibular Joint Disorders

Ancestor Terms

ID	Term
D017271	Craniomandibular Disorders
D008336	Mandibular Diseases
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

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Browse Branches

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