Platelet-rich Plasma Injection for Temporomandibular Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Temporomandibular disorder (TMD) involves the temporomandibular joint (TMJ) and surrounding structure, causing problems including myofascial pain and joint degeneration. TMD is mostly seen in the age group of 18 to 44. TMD treatment includes conservative (non-surgical) and surgical treatment. Surgical TMD treatment has a decent success rate but requires general anesthesia, hospital stay and surgical incision. There are also some risks of facial nerve and vascular damage, infection, puncture to middle cranial fossa. Conservative treatments include medication , physical therapy, use of occlusal splint, hyaluronic acid (HA) or Botulinum toxin injection and concentrated glucose solution. However, those managements lack the evidence from large placebo-controlled clinical trials. Therefore, the development of novel non-surgical treatment is important and of great potential. The ultrasound guidance provides visualization of the lesion site, allowing the operator to provide injection precisely and avoid damage on adjacent tissue, nerves and vessels. it is not only convenient and economic, but also associated with significantly less radiation exposure than conventional techniques such as computer tomography or fluoroscopy. Using ultrasound guidance in injective TMD treatment can increase successful rate and prevent unnecessary side effects. While current available evidences suggest the promising effect of platelet-rich plasma (PRP) injection therapy in treating TMD, publication of study with strict design is still lacking. Therefore, this study is a randomized, controlled and double-blind design, which aimed to access the efficacy of ultrasound-guided PRP injection therapy of TMD, with normal saline used as control. Looking forward to establish TMD clinical treatment guideline in the future.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Platelet-Rich Plasma in the Therapy of Temporomandibular Disorders

NCT03371888

PRP Temporomandibular Disorder Myalgia +1 more

COMPLETED PHASE2/PHASE3

Effects of Platelet-rich Plasma Prolotherapy of Temporomandibular Joint Subluxation

NCT03655275

Temporomandibular Joint Disorders

UNKNOWN EARLY_PHASE1

Temporomandibular Disorder (TMD) Pain in Response to Jaw Advancement in People With TMD and Obstructive Sleep Apnea

NCT02685202

Myalgia Apnea, Obstructive Sleep

TERMINATED NA

Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Randomized Single Blinded Investigational Trial

NCT02295644

Temporomandibular Joint Dysfunction Syndrome

COMPLETED NA

Comparative Efficacy of PRP and Dry Needling in Management of Trigger Points in Masseter Muscle in MPS Patients

NCT04286880

Myofascial Pain Syndrome

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Objectives:

Temporomandibular disorder (TMD) involves the temporomandibular joint (TMJ) and surrounding structure, causing problems including myofascial pain and joint degeneration. TMD is mostly seen in the age group of 18 to 44. TMD treatment includes conservative (non-surgical) and surgical treatment. Surgical TMD treatment has a decent success rate but requires general anesthesia, hospital stay and surgical incision. There are also some risks of facial nerve and vascular damage, infection, puncture to middle cranial fossa. Conservative treatments include medication , physical therapy, use of occlusal splint, hyaluronic acid (HA) or Botulinum toxin injection and concentrated glucose solution. However, those managements lack the evidence from large placebo-controlled clinical trials. Therefore, the development of novel non-surgical treatment is important and of great potential. The ultrasound guidance provides visualization of the lesion site, allowing the operator to provide injection precisely and avoid damage on adjacent tissue, nerves and vessels. it is not only convenient and economic, but also associated with significantly less radiation exposure than conventional techniques such as computer tomography or fluoroscopy. Using ultrasound guidance in injective TMD treatment can increase successful rate and prevent unnecessary side effects. While current available evidences suggest the promising effect of platelet-rich plasma (PRP) injection therapy in treating TMD, publication of study with strict design is still lacking. Therefore, this study is a randomized, controlled and double-blind design, which aimed to access the efficacy of ultrasound-guided PRP injection therapy of TMD, with normal saline used as control. Looking forward to establish TMD clinical treatment guideline in the future.

Methods:

The out-patients with unilateral or bilateral TMD、joint mobility dysfunction or joint noise from this hospital were enrolled. They were randomized via computer into 2 groups (PRP group and normal saline group). There are 30 patients in each group. The PRP group received 1cc PRP injection in the superior temporomandibular disk joint space by ultrasound guidance. The normal saline group received the same procedure as PRP group with 1 cc normal saline injection. Both group received the same protocol of physical therapy (manual therapy, stretching exercise, posture training with 30 minutes per session and 2 sessions per weeks) for 12 weeks. Those physical therapies were under the guidance of one therapist who didn't know the patient's allocation.

The investigator and subjects did not know the group assignment. Evaluations were performed at time points prior to injection and 2 weeks, 1st, 3rd , and 6th months post injection by one doctor (who didn't know about the group assignment). Evaluations include Visual Analogue Scale (VAS) of the degree of pain, masticatory efficiency, perceived joint noise and measure of maximal interincisal opening, painless oral opening, mandibular lateral movement and protrusion movement. The investigator also evaluated symptoms or signs of side effects and complications.

Besides, the subjects can't receive any treatment include medications or injection for pain control, but allowed to take Acetaminophen 500mg, maximal dosage 4g per day to relieve refractory pain during follow up period. If any participant broke the rules or took Acetaminophen over daily dosage, the participant will be excluded to this study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Temporomandibular Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

access the efficacy of ultrasound-guided PRP injection therapy of TMD, with normal saline used as control group.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

platelet-rich plasma injection

1cc platelet-rich plasma(PRP) injection in the superior temporomandibular disk joint space by ultrasound guidance.

Group Type EXPERIMENTAL

platelet-rich plasma injection therapy of TMD

Intervention Type PROCEDURE

The administer injected 1cc PRP in the superior temporomandibular disk joint space by ultrasound guidance.

normal saline injection

1cc normal saline injection in the superior temporomandibular disk joint space by ultrasound guidance.

Group Type PLACEBO_COMPARATOR

platelet-rich plasma injection therapy of TMD

Intervention Type PROCEDURE

The administer injected 1cc PRP in the superior temporomandibular disk joint space by ultrasound guidance.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

platelet-rich plasma injection therapy of TMD

The administer injected 1cc PRP in the superior temporomandibular disk joint space by ultrasound guidance.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age between 20-80 year-old.
* Duration of symptoms ( temporomandibular joint pain or tenderness, joint noise or joint motility dysfunction)more than 3 months.
* Diagnosis was confirmed by using the original Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) and the severity at least Grade II.

Exclusion Criteria

* Head and neck cancer
* Neurological disease
* Cognition impairment
* Coagulopathy
* Pregnancy
* Inflammation status
* Infection status
* Previously undergone wrist surgery or steroid injection for TMD

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes