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OpenTrials
Completed

NCT Number: NCT07532798

Impact of Platelet Concentration in PRP on TMJ Subluxation

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.

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Key information

Conditions

Temporomandibular Disorders (TMDs) Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients aged ≥ 18 years -

Exclusion criteria

patients aged < 18 years

-

Treatment and study plan

Low Platelet Concentration PRP (L-PRP)

Procedure

Intra-articular and pericapsular injection of platelet-rich plasma prepared with Low platelet concentration..

High Platelet Concentration PRP (L-PRP)

Procedure

Intra-articular and pericapsular injection of platelet-rich plasma prepared with high platelet concentration.

Primary outcomes

  1. 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.

  2. Frequency of TMJ locking

    Time frame: Baseline, 6 months, and 5 years

    Frequency of locking, expressed as number of episodes per day

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

IBB University

Other

Registry information

Official study title

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

Acronym: PRPTMJ

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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