The Platelet-Rich Plasma in the Therapy of Temporomandibular Disorders

Phase 2

Completed

• Conditions: PRP; Myalgia; Bruxism; Temporomandibular Disorder
• Interventions: Biological: Platelet-Rich Plasma intramuscular injections

• Registration Number: NCT03371888
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-12-07
• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-13
• Primary Completion: 2018-12-15
• Status Verified: 2019-01
• Study Completion: 2019-01-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP injections	Platelet-Rich Plasma intramuscular injections	Intramuscular injection of Platelet-Rich Plasma into the masseter and temporalis muscle

Primary Outcome Measures

Name	Time	Method
Pain intensity reduction in VAS scale,(VAS scale 0-10 points)	14 days	Decrease in pain intensity in masseter and temporalis muscles.

Trial Locations

Locations (1)

Department of TMD Silesian Medical University; 🇵🇱 Zabrze, Poland