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

January 2, 2019 updated by: Aleksandra Nitecka-Buchta, Medical University of Silesia

The Platelet -Rich Plasma in the Therapy of Temporomandibular Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Zabrze, Poland, 41-800
        • Department of TMD Silesian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRP injections
Intramuscular injection of Platelet-Rich Plasma into the masseter and temporalis muscle
Biological: Platelet-Rich Plasma intramuscular injections
A platelet-rich plasma intramuscular injections into the trigger points of painful muscles were performed.
Other Names:
  • PRP intramuscular injections
Placebo Comparator: 0,9% NaCl injections
Intramuscular injection of 0,9% NaCl into the masseter and temporalis muscle
Biological: Placebo Comparator: 0,9% NaCl intramuscular injections
A 0,9% NaCl intramuscular injections into the trigger points of painful muscles were performed.
Other Names:
  • Saline intramuscular injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity reduction in VAS scale,(VAS scale 0-10 points)
Time Frame: 14 days
Decrease in pain intensity in masseter and temporalis muscles.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Investigators

  • Principal Investigator: Aleksandra Nitecka-Buchta, DMD, Medical University of Silesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2017

Primary Completion (Actual)

December 15, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

December 7, 2017

First Posted (Actual)

December 13, 2017

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Silesian MU PRP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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