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

Medical University of Silesia

Status and phase: Completed; Phase 3; Phase 2

Conditions: Myalgia; Bruxism; PRP; Temporomandibular Disorder

Treatments: Biological: Platelet-Rich Plasma intramuscular injections; Biological: Placebo Comparator: 0,9% NaCl intramuscular injections

Study type: Interventional

Funder types: Other

Identifiers

NCT03371888

Silesian MU PRP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 23 to 42 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups, including a placebo group

PRP injections

Experimental group

Description:

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

Treatment:

Biological: Platelet-Rich Plasma intramuscular injections

0,9% NaCl injections

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo Comparator: 0,9% NaCl intramuscular injections