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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03371888
Other study ID # Silesian MU PRP
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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.


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Study Design


Related Conditions & MeSH terms


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)

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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
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