Temporomandibular Disorder Clinical Trial
— PRP/TMDOfficial title:
The Platelet -Rich Plasma in the Therapy of Temporomandibular Disorders
Verified date | January 2019 |
Source | Medical University of Silesia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 58 |
Est. completion date | January 1, 2019 |
Est. primary completion date | December 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 23 Years to 42 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Department of TMD Silesian Medical University | Zabrze |
Lead Sponsor | Collaborator |
---|---|
Medical University of Silesia |
Poland,
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Pihut M, Ferendiuk E, Szewczyk M, Kasprzyk K, Wieckiewicz M. The efficiency of botulinum toxin type A for the treatment of masseter muscle pain in patients with temporomandibular joint dysfunction and tension-type headache. J Headache Pain. 2016;17:29. doi: 10.1186/s10194-016-0621-1. Epub 2016 Mar 24. — View Citation
Salamanna F, Veronesi F, Maglio M, Della Bella E, Sartori M, Fini M. New and emerging strategies in platelet-rich plasma application in musculoskeletal regenerative procedures: general overview on still open questions and outlook. Biomed Res Int. 2015;2015:846045. doi: 10.1155/2015/846045. Epub 2015 May 5. Review. — View Citation
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Tsai WC, Yu TY, Chang GJ, Lin LP, Lin MS, Pang JS. Platelet-Rich Plasma Releasate Promotes Regeneration and Decreases Inflammation and Apoptosis of Injured Skeletal Muscle. Am J Sports Med. 2018 Jul;46(8):1980-1986. doi: 10.1177/0363546518771076. Epub 2018 May 17. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain intensity reduction in VAS scale,(VAS scale 0-10 points) | Decrease in pain intensity in masseter and temporalis muscles. | 14 days |
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