Platelet-rich Plasma Injection for Temporomandibular Disorders

NCT04127942 | Withdrawn

• 1 other identifier: 2-106-05-026
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Temporomandibular Disorder

Keywords

platelet-rich plasma; ultrasound guided injection.; Temporomandibular disorder

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) of the degree of pain

  \*. Visual Analogue Scale of the degree of pain: with the score ranging from 10 (tremendous pain) to 0 (no pain).

  6 months

Secondary Outcomes (4)

• measure of maximal interincisal opening and painless mouth opening

  6 months

• measure of maximal mandibular excursion and protrusion.

  6 months

• Visual Analogue Scale of masticatory efficiency

  6 months

• Visual Analogue Scale of perceived joint noise

  6 months

Study Arms (2)

platelet-rich plasma injection

EXPERIMENTAL

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

Procedure: platelet-rich plasma injection therapy of TMD

normal saline injection

PLACEBO COMPARATOR

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

Procedure: platelet-rich plasma injection therapy of TMD

Interventions

platelet-rich plasma injection therapy of TMD PROCEDURE

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

normal saline injection; platelet-rich plasma injection

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Related Publications (6)

• Cooper BC, Kleinberg I. Examination of a large patient population for the presence of symptoms and signs of temporomandibular disorders. Cranio. 2007 Apr;25(2):114-26. doi: 10.1179/crn.2007.018.

  PMID: 17508632 BACKGROUND

• Gencer ZK, Ozkiris M, Okur A, Korkmaz M, Saydam L. A comparative study on the impact of intra-articular injections of hyaluronic acid, tenoxicam and betametazon on the relief of temporomandibular joint disorder complaints. J Craniomaxillofac Surg. 2014 Oct;42(7):1117-21. doi: 10.1016/j.jcms.2014.01.041. Epub 2014 Feb 4.

  PMID: 24853591 BACKGROUND

• Martins WR, Blasczyk JC, Aparecida Furlan de Oliveira M, Lagoa Goncalves KF, Bonini-Rocha AC, Dugailly PM, de Oliveira RJ. Efficacy of musculoskeletal manual approach in the treatment of temporomandibular joint disorder: A systematic review with meta-analysis. Man Ther. 2016 Feb;21:10-7. doi: 10.1016/j.math.2015.06.009. Epub 2015 Jun 25.

  PMID: 26144684 BACKGROUND

• Kummoona R. Surgical managements of subluxation and dislocation of the temporomandibular joint: clinical and experimental studies. J Craniofac Surg. 2010 Nov;21(6):1692-7. doi: 10.1097/SCS.0b013e3181f3c682.

  PMID: 21119402 BACKGROUND

• Sivri MB, Ozkan Y, Pekiner FN, Gocmen G. Comparison of ultrasound-guided and conventional arthrocentesis of the temporomandibular joint. Br J Oral Maxillofac Surg. 2016 Jul;54(6):677-81. doi: 10.1016/j.bjoms.2016.04.004. Epub 2016 Apr 23.

  PMID: 27118616 BACKGROUND

• Fernandez-Ferro M, Fernandez-Sanroman J, Blanco-Carrion A, Costas-Lopez A, Lopez-Betancourt A, Arenaz-Bua J, Stavaru Marinescu B. Comparison of intra-articular injection of plasma rich in growth factors versus hyaluronic acid following arthroscopy in the treatment of temporomandibular dysfunction: A randomised prospective study. J Craniomaxillofac Surg. 2017 Apr;45(4):449-454. doi: 10.1016/j.jcms.2017.01.010. Epub 2017 Jan 25.

  PMID: 28237253 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Liang-Cheng Chen, MD,MS

  Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Department of Physical Medicine and Rehabilitation

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

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: October 16, 2019
• Study Start: November 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share