The Platelet-Rich Plasma in the Therapy of Temporomandibular Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Platelet -Rich Plasma in the Therapy of Temporomandibular Disorders

Conditions
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PRP, Temporomandibular Disorder, Myalgia, Bruxism

Intervention / Treatment
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* Biological: Platelet-Rich Plasma intramuscular injections
* Biological: Placebo Comparator: 0,9% NaCl intramuscular injections


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An intervention performed in experimental group and control group
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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