Impact of Platelet Concentration in PRP on TMJ Subluxation (PRPTMJ)

April 9, 2026 updated by: radwan saleh algabri, IBB University

Effect of Platelet Concentration in Platelet-Rich Plasma on Prolotherapy Outcomes in Temporomandibular Joint Subluxation: A Double-Blinded Randomized Clinical Trial

This study is about a treatment for a jaw condition called temporomandibular joint (TMJ) subluxation. In this condition, the jaw can move too far forward during mouth opening, which may cause repeated jaw locking and problems with normal function.

The treatment being studied is platelet-rich plasma (PRP) injections. PRP is made from a person's own blood and may help improve joint stability and reduce symptoms.

In this study, 40 adults with TMJ subluxation were randomly assigned to receive PRP with either a lower or higher platelet concentration. Each participant received 2 injections, given 2 weeks apart.

The study measured jaw pain, how often locking happened, mouth opening, and joint clicking before treatment, after 6 months, and after 5 years.

The goal of this study is to find out whether the amount of platelets in PRP changes how well this treatment works.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective, double-blinded, parallel-group randomized clinical trial was conducted to evaluate whether platelet concentration influences the clinical efficacy of platelet-rich plasma (PRP) prolotherapy in the management of temporomandibular joint (TMJ) subluxation. TMJ subluxation is characterized by recurrent episodes of excessive anterior translation of the mandibular condyle beyond the articular eminence, often resulting in transient jaw locking and functional impairment.

A total of 40 adult patients (≥18 years) diagnosed with TMJ subluxation according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), supported by imaging evidence, were enrolled and randomly allocated in a 1:1 ratio into two groups: low-concentration PRP (L-PRP) and high-concentration PRP (H-PRP). PRP was prepared using standardized centrifugation protocols (1,500 rpm for L-PRP and 3,200 rpm for H-PRP). All participants received two intra-articular and pericapsular injections separated by a 2-week interval.

The primary outcomes were TMJ pain on function, assessed using a visual analog scale (VAS), and frequency of joint locking (episodes/day). Secondary outcomes included maximal mouth opening (MMO, mm) and presence of joint clicking. Outcomes were assessed at baseline, 6 months, and 5 years following treatment.

The study aimed to determine whether variations in platelet concentration affect clinical outcomes of PRP prolotherapy and to provide evidence for optimizing PRP preparation protocols in the management of TMJ subluxation.

Study Type

Interventional

Enrollment (Actual)

40

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

  • Egypt
      • Cairo, Egypt
        • Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo 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

No

Description

Inclusion Criteria: patients aged ≥ 18 years -

Exclusion Criteria: patients aged < 18 years

-

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low Platelet Concentration PRP (L-PRP)
Patients received prolotherapy using platelet-rich plasma with low platelet concentration.
Procedure: Low Platelet Concentration PRP (L-PRP)
Intra-articular and pericapsular injection of platelet-rich plasma prepared with Low platelet concentration..
Active Comparator: High Platelet Concentration PRP (H-PRP)
Patients received prolotherapy using platelet-rich plasma with high platelet concentration.
Procedure: High Platelet Concentration PRP (L-PRP)
Intra-articular and pericapsular injection of platelet-rich plasma prepared with high platelet concentration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TMJ Pain on Function
Time Frame: Baseline, 6 months, and 5 years
Pain during jaw function measured using a visual analog scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates worst pain.
Baseline, 6 months, and 5 years
Frequency of TMJ locking
Time Frame: Baseline, 6 months, and 5 years
Frequency of locking, expressed as number of episodes per day
Baseline, 6 months, and 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum mouth opening (MMO)
Time Frame: Baseline, 6 months, and 5 years
MMO measured as the distance in mm between the incisal edges of the upper and lower central incisors using a ruler.
Baseline, 6 months, and 5 years
Presence of joint clicking
Time Frame: Baseline, 6 months, and 5 years
TMJ clicking, recorded as present or absent based on periauricular palpation during mandibular movement.
Baseline, 6 months, and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IBB University

Investigators

  • Principal Investigator: Hamida Refai, PhD, Cairo University

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)

April 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CU-TMJ-PRP-RCT-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to institutional regulations and ethical considerations regarding patient confidentiality and data protection.

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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