The Platelet-Rich Plasma in the Therapy of Temporomandibular Disorders

NCT03371888 | Completed Phase 2

• 1 other identifier: Silesian MU PRP
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The Platelet-Rich Plasma intramuscular injections into the masseter and temporalis muscle were performed to reduce painful temporomandibular disorder symptoms,such as myalgia, myofascial pain and myofascial pain with referrals. Patients(n=120) were randomly divided into two groups: experimental(n=60) and control group(n=60). In controls injections with 0,9% NaCl were performed. Pain intensity was measured with NPRS (numeriic pain rating scale, 0= no pain, 11= the worst pain that one can imagine) before(0 day), during(10 day) and after(20 day) the therapy with PRP injections.

Conditions

PRP; Temporomandibular Disorder; Myalgia; Bruxism

Outcome Measures

Primary Outcomes (1)

• Pain intensity reduction in VAS scale,(VAS scale 0-10 points)

  Decrease in pain intensity in masseter and temporalis muscles.

  14 days

Study Arms (2)

PRP injections

EXPERIMENTAL

Intramuscular injection of Platelet-Rich Plasma into the masseter and temporalis muscle

Biological: Platelet-Rich Plasma intramuscular injections

0,9% NaCl injections

PLACEBO COMPARATOR

Intramuscular injection of 0,9% NaCl into the masseter and temporalis muscle

Biological: Placebo Comparator: 0,9% NaCl intramuscular injections

Interventions

Platelet-Rich Plasma intramuscular injections BIOLOGICAL

A platelet-rich plasma intramuscular injections into the trigger points of painful muscles were performed.

Also known as: PRP intramuscular injections

PRP injections

Placebo Comparator: 0,9% NaCl intramuscular injections BIOLOGICAL

A 0,9% NaCl intramuscular injections into the trigger points of painful muscles were performed.

Also known as: Saline intramuscular injections

0,9% NaCl injections

Eligibility Criteria

• Age: 23 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• presence of local myalgia, myofascial pain and myofascial pain with referral within masseter muscles according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) (II.1.A. 1, 2 and 3)
• patient's agreement for taking part into the research study

You may not qualify if:

• patients being treated with or addicted to analgesic drugs and/or drugs that affect muscle function
• presence of contraindications for injection therapy
• patients being treated by neurologist for neurological disorders and/or neuropathic pain and/or headache
• patients after traumas to the head and neck region in the previous 2 years
• edentulous patients
• patients after radiotherapy
• presence of severe mental disorders
• pregnancy or lactation
• pain of dental origin
• presence of malignancy
• drug and/or alcohol addiction
• patients with needle phobia

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

Department of TMD Silesian Medical University

Zabrze, 41-800, Poland

Location

Related Publications (8)

• Wright EF, North SL. Management and treatment of temporomandibular disorders: a clinical perspective. J Man Manip Ther. 2009;17(4):247-54. doi: 10.1179/106698109791352184.

  PMID: 20140156 BACKGROUND

• Xie X, Zhang C, Tuan RS. Biology of platelet-rich plasma and its clinical application in cartilage repair. Arthritis Res Ther. 2014 Feb 25;16(1):204. doi: 10.1186/ar4493.

  PMID: 25164150 BACKGROUND

• Amable PR, Carias RB, Teixeira MV, da Cruz Pacheco I, Correa do Amaral RJ, Granjeiro JM, Borojevic R. Platelet-rich plasma preparation for regenerative medicine: optimization and quantification of cytokines and growth factors. Stem Cell Res Ther. 2013 Jun 7;4(3):67. doi: 10.1186/scrt218.

  PMID: 23759113 BACKGROUND

• Salamanna F, Veronesi F, Maglio M, Della Bella E, Sartori M, Fini M. New and emerging strategies in platelet-rich plasma application in musculoskeletal regenerative procedures: general overview on still open questions and outlook. Biomed Res Int. 2015;2015:846045. doi: 10.1155/2015/846045. Epub 2015 May 5.

  PMID: 26075269 BACKGROUND

• Stiles CD. The molecular biology of platelet-derived growth factor. Cell. 1983 Jul;33(3):653-5. doi: 10.1016/0092-8674(83)90008-9.

  PMID: 6307524 BACKGROUND

• Pihut M, Ferendiuk E, Szewczyk M, Kasprzyk K, Wieckiewicz M. The efficiency of botulinum toxin type A for the treatment of masseter muscle pain in patients with temporomandibular joint dysfunction and tension-type headache. J Headache Pain. 2016;17:29. doi: 10.1186/s10194-016-0621-1. Epub 2016 Mar 24.

  PMID: 27011213 BACKGROUND

• Tsai WC, Yu TY, Chang GJ, Lin LP, Lin MS, Pang JS. Platelet-Rich Plasma Releasate Promotes Regeneration and Decreases Inflammation and Apoptosis of Injured Skeletal Muscle. Am J Sports Med. 2018 Jul;46(8):1980-1986. doi: 10.1177/0363546518771076. Epub 2018 May 17.

  PMID: 29772187 BACKGROUND

• Mazzocca AD, McCarthy MB, Chowaniec DM, Cote MP, Romeo AA, Bradley JP, Arciero RA, Beitzel K. Platelet-rich plasma differs according to preparation method and human variability. J Bone Joint Surg Am. 2012 Feb 15;94(4):308-16. doi: 10.2106/JBJS.K.00430.

  PMID: 22336969 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Myalgia; Bruxism

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Habits; Behavior

Study Officials

• Aleksandra Nitecka-Buchta, DMD

  Medical University of Silesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DMD, PhD

Model Details: An intervention performed in experimental group and control group

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 13, 2017
• Study Start: December 7, 2017
• Primary Completion: December 15, 2018
• Study Completion: January 1, 2019
• Last Updated: January 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)