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

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ClinicalTrials.gov Identifier: NCT03371888
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Aleksandra Nitecka-Buchta, Medical University of Silesia

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. pain

Condition or disease Intervention/treatment Phase
PRP Temporomandibular Disorder Myalgia Bruxism Biological: Platelet-Rich Plasma intramuscular injections Biological: Placebo Comparator: 0,9% NaCl intramuscular injections Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An intervention performed in experimental group and control group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Platelet -Rich Plasma in the Therapy of Temporomandibular Disorders
Actual Study Start Date : December 7, 2017
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : December 15, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Saline intramuscular injections




Primary Outcome Measures :
  1. Pain intensity reduction in NPRS (numeric pain rating scale 0-11 points) scale, [ Time Frame: 20 days ]
    Decrease in pain intensity in masseter and temporalis muscles.



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Ages Eligible for Study:   23 Years to 42 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

myalgia (ICD-9729.1) i myofascial pain with referrals (ICD-10 M 79.1), night bruxism (International Classification of Sleep Disorders: ICSD-2 327.53 ( G47. 63))

Exclusion Criteria:

  • thrombolytic disorders, pregnancy, menstruation, uncontrolled bleeding after venopunction, anticoagulants,

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): NCT03371888


Contacts
Contact: Aleksandra Nitecka-Buchta 0048601899069 aleksandra.nitecka@sum.edu.pl

Locations
Poland
Department of TMD and Orthodontics Silesian Medical University Recruiting
Zabrze, Poland, 41-800
Contact: Stefan Baron, Prof    0048322717217    s.baron@sum.edu.pl   
Principal Investigator: Aleksandra Nitecka-Buchta, D.M.D.         
Sponsors and Collaborators
Medical University of Silesia
Investigators
Principal Investigator: Aleksandra Nitecka-Buchta, DMD Medical University of Silesia

Publications:
Responsible Party: Aleksandra Nitecka-Buchta, DMD, PhD, Medical University of Silesia
ClinicalTrials.gov Identifier: NCT03371888     History of Changes
Other Study ID Numbers: Silesian MU PRP
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Disease
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Tooth Diseases
Nervous System Diseases
Neuromuscular Diseases
Bruxism
Myalgia
Pathologic Processes
Myofascial Pain Syndromes
Musculoskeletal Pain
Pain
Neurologic Manifestations
Signs and Symptoms