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The Platelet-Rich Plasma in the Therapy of Temporomandibular Disorders

The Platelet -Rich Plasma in the Therapy of Temporomandibular Disorders

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03371888
Acronym
PRP/TMD
Enrollment
58
Registered
2017-12-13
Start date
2017-12-07
Completion date
2019-01-01
Last updated
2019-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism, Myalgia, PRP, Temporomandibular Disorder

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.

Interventions

BIOLOGICALPlatelet-Rich Plasma intramuscular injections

A platelet-rich plasma intramuscular injections into the trigger points of painful muscles were performed.

BIOLOGICALPlacebo Comparator: 0,9% NaCl intramuscular injections

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

Sponsors

Medical University of Silesia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

double blinded study

Intervention model description

An intervention performed in experimental group and control group

Eligibility

Sex/Gender
ALL
Age
23 Years to 42 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity reduction in VAS scale,(VAS scale 0-10 points)14 daysDecrease in pain intensity in masseter and temporalis muscles.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026