The Platelet-Rich Plasma in the Therapy of Temporomandibular Disorders

NCT ID: NCT03371888

Last Updated: 2019-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-07
• Study Completion Date: 2019-01-01

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.

Conditions

PRP; Temporomandibular Disorder; Myalgia; Bruxism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PRP injections

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

Group Type: EXPERIMENTAL

Platelet-Rich Plasma intramuscular injections

Intervention Type: BIOLOGICAL

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

0,9% NaCl injections

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

Group Type: PLACEBO_COMPARATOR

Placebo Comparator: 0,9% NaCl intramuscular injections

Intervention Type: BIOLOGICAL

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

Interventions

Platelet-Rich Plasma intramuscular injections

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

Intervention Type: BIOLOGICAL

Placebo Comparator: 0,9% NaCl intramuscular injections

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

Intervention Type: BIOLOGICAL

Other Intervention Names

PRP intramuscular injections; Saline intramuscular injections

Eligibility Criteria

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

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Silesia

OTHER

Sponsor Role: lead

Responsible Party

Aleksandra Nitecka-Buchta

DMD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aleksandra Nitecka-Buchta, DMD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Silesia

Locations

Department of TMD Silesian Medical University

Zabrze, , Poland

Countries

Poland

References

Wright EF, North SL. Management and treatment of temporomandibular disorders: a clinical perspective. J Man Manip Ther. 2009;17(4):247-54. doi: 10.1179/106698109791352184.

Reference Type: BACKGROUND

PMID: 20140156 (View on PubMed)

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. doi: 10.1186/ar4493.

Reference Type: BACKGROUND

PMID: 25164150 (View on PubMed)

Amable PR, Carias RB, Teixeira MV, da Cruz Pacheco I, Correa 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.

Reference Type: BACKGROUND

PMID: 23759113 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26075269 (View on PubMed)

Stiles CD. The molecular biology of platelet-derived growth factor. Cell. 1983 Jul;33(3):653-5. doi: 10.1016/0092-8674(83)90008-9.

Reference Type: BACKGROUND

PMID: 6307524 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27011213 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29772187 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22336969 (View on PubMed)

Other Identifiers

Silesian MU PRP

Identifier Type: -

Identifier Source: org_study_id