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.

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Key information

Conditions

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

Age range

23 year–42 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of TMD Silesian Medical University

Zabrze, 41-800, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet-Rich Plasma intramuscular injections

Biological

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 intramuscular injections

Biological

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

Other names: Saline intramuscular injections

Primary outcomes

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

Time frame: 14 days

Decrease in pain intensity in masseter and temporalis muscles.

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

The Platelet -Rich Plasma in the Therapy of Temporomandibular Disorders

Acronym: PRP/TMD

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: Dec 13, 2017
Registry last updated: Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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