The Platelet-Rich Plasma in the Therapy of Temporomandibular Disorders

Temporomandibular Disorder Clinical Trial

— PRP/TMD  

Official title:

The Platelet -Rich Plasma in the Therapy of Temporomandibular Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03371888
• Other study ID #: Silesian MU PRP
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 7, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: January 2019
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bruxism
• Disease
• Myalgia
• PRP
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Biological:
• Platelet-Rich Plasma intramuscular injections
A platelet-rich plasma intramuscular injections into the trigger points of painful muscles were performed.
• Placebo Comparator: 0,9% NaCl intramuscular injections
A 0,9% NaCl intramuscular injections into the trigger points of painful muscles were performed.

Locations

Country	Name	City	State
Poland	Department of TMD Silesian Medical University	Zabrze

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

References & Publications (8)

Amable PR, Carias RB, Teixeira MV, da Cruz Pacheco I, Corrêa do Amaral RJ, Granjeiro JM, Borojevic R. Platelet-rich plasma preparation for regenerative medicine: optimization and quantification of cytokines and growth factors. Stem Cell Res Ther. 2013 Jun 7;4(3):67. doi: 10.1186/scrt218. — View Citation

Mazzocca AD, McCarthy MB, Chowaniec DM, Cote MP, Romeo AA, Bradley JP, Arciero RA, Beitzel K. Platelet-rich plasma differs according to preparation method and human variability. J Bone Joint Surg Am. 2012 Feb 15;94(4):308-16. doi: 10.2106/JBJS.K.00430. — View Citation

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

Stiles CD. The molecular biology of platelet-derived growth factor. Cell. 1983 Jul;33(3):653-5. — View Citation

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

Wright EF, North SL. Management and treatment of temporomandibular disorders: a clinical perspective. J Man Manip Ther. 2009;17(4):247-54. — View Citation

Xie X, Zhang C, Tuan RS. Biology of platelet-rich plasma and its clinical application in cartilage repair. Arthritis Res Ther. 2014 Feb 25;16(1):204. Review. — View Citation

Outcome

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