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The Platelet-Rich Plasma in the Therapy of Temporomandibular Disorders (PRP/TMD)

Primary Purpose

PRP, Temporomandibular Disorder, Myalgia

Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Platelet-Rich Plasma intramuscular injections
Placebo Comparator: 0,9% NaCl intramuscular injections
Sponsored by
Medical University of Silesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PRP

Eligibility Criteria

23 Years - 42 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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)
  2. patient's agreement for taking part into the research study

Exclusion Criteria:

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

Sites / Locations

  • Department of TMD Silesian Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRP injections

0,9% NaCl injections

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain intensity reduction in VAS scale,(VAS scale 0-10 points)
Decrease in pain intensity in masseter and temporalis muscles.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2017
Last Updated
January 2, 2019
Sponsor
Medical University of Silesia
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1. Study Identification

Unique Protocol Identification Number
NCT03371888
Brief Title
The Platelet-Rich Plasma in the Therapy of Temporomandibular Disorders
Acronym
PRP/TMD
Official Title
The Platelet -Rich Plasma in the Therapy of Temporomandibular Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Silesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Patients(n=120) attending The Department of Temporomandibular Disorders and Orthodontics at the Silesian Medical University Poland, Zabrze were enrolled to the study and randomly divided into one of two groups: experimental and control group. Platelet-Rich Plasma(PRP) was prepared for each patient and an intramuscular injections of 0,5 ml PRP into 6 points at each side were performed in experimental group. A follow-up appointment was made after 10 and 20 days and in each visit an injection of PRP or 0,9% NaCl was performed. Pain intensity was measured in NPRS(numeric pain rating scale) and collected data data were analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PRP, Temporomandibular Disorder, Myalgia, Bruxism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
An intervention performed in experimental group and control group
Masking
ParticipantCare Provider
Masking Description
double blinded study
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP injections
Arm Type
Experimental
Arm Description
Intramuscular injection of Platelet-Rich Plasma into the masseter and temporalis muscle
Arm Title
0,9% NaCl injections
Arm Type
Placebo Comparator
Arm Description
Intramuscular injection of 0,9% NaCl into the masseter and temporalis muscle
Intervention Type
Biological
Intervention Name(s)
Platelet-Rich Plasma intramuscular injections
Other Intervention Name(s)
PRP intramuscular injections
Intervention Description
A platelet-rich plasma intramuscular injections into the trigger points of painful muscles were performed.
Intervention Type
Biological
Intervention Name(s)
Placebo Comparator: 0,9% NaCl intramuscular injections
Other Intervention Name(s)
Saline intramuscular injections
Intervention Description
A 0,9% NaCl intramuscular injections into the trigger points of painful muscles were performed.
Primary Outcome Measure Information:
Title
Pain intensity reduction in VAS scale,(VAS scale 0-10 points)
Description
Decrease in pain intensity in masseter and temporalis muscles.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandra Nitecka-Buchta, DMD
Organizational Affiliation
Medical University of Silesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of TMD Silesian Medical University
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20140156
Citation
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.
Results Reference
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PubMed Identifier
25164150
Citation
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.
Results Reference
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PubMed Identifier
23759113
Citation
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.
Results Reference
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PubMed Identifier
26075269
Citation
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.
Results Reference
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PubMed Identifier
6307524
Citation
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.
Results Reference
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PubMed Identifier
27011213
Citation
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.
Results Reference
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PubMed Identifier
29772187
Citation
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.
Results Reference
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PubMed Identifier
22336969
Citation
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.
Results Reference
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The Platelet-Rich Plasma in the Therapy of Temporomandibular Disorders

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