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Platelet-rich Plasma Injection for Temporomandibular Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04127942
Recruitment Status : Withdrawn (no sufficient enrolled pateints)
First Posted : October 16, 2019
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Liang-Cheng Chen, Tri-Service General Hospital

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.

Condition or disease Intervention/treatment Phase
Temporomandibular Disorder Procedure: platelet-rich plasma injection therapy of TMD Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: access the efficacy of ultrasound-guided PRP injection therapy of TMD, with normal saline used as control group.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Six-month Efficacy of Ultrasound-guided Platelet-rich Plasma Injection for Temporomandibular Disorders
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: platelet-rich plasma injection
1cc platelet-rich plasma(PRP) injection in the superior temporomandibular disk joint space by ultrasound guidance.
Procedure: platelet-rich plasma injection therapy of TMD
The administer injected 1cc PRP in the superior temporomandibular disk joint space by ultrasound guidance.

Placebo Comparator: normal saline injection
1cc normal saline injection in the superior temporomandibular disk joint space by ultrasound guidance.
Procedure: platelet-rich plasma injection therapy of TMD
The administer injected 1cc PRP in the superior temporomandibular disk joint space by ultrasound guidance.




Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) of the degree of pain [ Time Frame: 6 months ]
    *. Visual Analogue Scale of the degree of pain: with the score ranging from 10 (tremendous pain) to 0 (no pain).


Secondary Outcome Measures :
  1. measure of maximal interincisal opening and painless mouth opening [ Time Frame: 6 months ]
    The subject was instructed, "Open your mouth as wide as possible without causing pain or discomfort." Then, using ruler to measured the intercisal distance (cm) by placing the ruler between central incisors.

  2. measure of maximal mandibular excursion and protrusion. [ Time Frame: 6 months ]
    • Excursion: Vertical marks were made on the anterior surface of the lower central incisors in relationship to the upper central incisors and the subject was instructed to "move your jaw as far to the side as you can comfortably." The measurement was taken as the horizontal distance between the 2 marks when the jaw was moved to the left and the right by using ruler to measured the intercisal distance (cm)
    • Protrusion: Two vertical lines were made on the first upper and lower canine incisors. The subject was instructed to "move your jaw as far forward as you can." The measurement was taken as the distance between the 2 marks by using ruler to measured the intercisal distance (cm)

  3. Visual Analogue Scale of masticatory efficiency [ Time Frame: 6 months ]
    *. Visual Analogue Scale of masticatory efficiency:with the score ranging from 10 (good; can eat solid food) to 0 (poor; only liquid diet)

  4. Visual Analogue Scale of perceived joint noise [ Time Frame: 6 months ]
    *. Visual Analogue Scale of perceived joint noise: with the score ranging from 10 (much noise) to 0 (no noise).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04127942


Sponsors and Collaborators
Tri-Service General Hospital
Investigators
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Principal Investigator: Liang-Cheng Chen, MD,MS Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Publications:

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Responsible Party: Liang-Cheng Chen, Clinical Professor of Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT04127942    
Other Study ID Numbers: 2-106-05-026
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liang-Cheng Chen, Tri-Service General Hospital:
platelet-rich plasma
ultrasound guided injection.
Temporomandibular disorder
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Disease
Pathologic Processes
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes