PRPPhase 2/3PRP/TMDNCT03371888
The Platelet-Rich Plasma in the Therapy of Temporomandibular Disorders
A Phase 2/3 study testing Platelet-Rich Plasma intramuscular injections in people with PRP and Temporomandibular Disorder, run by Medical University of Silesia at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 23 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- PRP, Temporomandibular Disorder, Myalgia
- What is being tested?
- Platelet-Rich Plasma intramuscular injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 sitePoland
- Study dates
- 7 Dec 2017to 1 Jan 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
- patient's agreement for taking part into the research study
Who cannot join
- patients being treated with or addicted to analgesic drugs and/or drugs that affect muscle function
- presence of contraindications for injection therapy
- patients being treated by neurologist for neurological disorders and/or neuropathic pain and/or headache
- patients after traumas to the head and neck region in the previous 2 years
- edentulous patients
- patients after radiotherapy
Show all 12Show fewer
- presence of severe mental disorders
- pregnancy or lactation
- pain of dental origin
- presence of malignancy
- drug and/or alcohol addiction
- patients with needle phobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Platelet -Rich Plasma in the Therapy of Temporomandibular Disorders
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.
Read the 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
- Being tested
- Platelet-Rich Plasma intramuscular injections, Placebo Comparator: 0,9% NaCl intramuscular injections
- Medical subject headings
- Temporomandibular Joint Disorders, Myalgia, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Plasma intramuscular injectionsBiological
Also called PRP intramuscular injections
A platelet-rich plasma intramuscular injections into the trigger points of painful muscles were performed.
Placebo Comparator: 0,9% NaCl intramuscular injectionsBiological
Also called Saline intramuscular injections
A 0,9% NaCl intramuscular injections into the trigger points of painful muscles were performed.
| Study group | Role | What they receive |
|---|---|---|
| PRP injections | Experimental | Intramuscular injection of Platelet-Rich Plasma into the masseter and temporalis muscle Receives: Biological: Platelet-Rich Plasma intramuscular injections |
| 0,9% NaCl injections | Placebo comparator | Intramuscular injection of 0,9% NaCl into the masseter and temporalis muscle Receives: Biological: Placebo Comparator: 0,9% NaCl intramuscular injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity reduction in VAS scale,(VAS scale 0-10 points)
Decrease in pain intensity in masseter and temporalis muscles.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start7 Dec 2017
- Primary completion15 Dec 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PRPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An intervention performed in experimental group and control group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Nitecka-Buchta, Medical University of Silesia
- Investigators
- Aleksandra Nitecka-Buchta, DMD, Principal investigator, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371888
- Sponsor's protocol ID
- Silesian MU PRP
- Acronym
- PRP/TMD
- Status last verified
- Jan 2019
- First submitted
- 7 Dec 2017
- Last updated
- 4 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20140156Xie 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.
PubMed 25164150Amable 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.
PubMed 23759113Salamanna 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.
PubMed 26075269Stiles CD. The molecular biology of platelet-derived growth factor. Cell. 1983 Jul;33(3):653-5. doi: 10.1016/0092-8674(83)90008-9.
PubMed 6307524Pihut 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.
PubMed 27011213Tsai 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.
PubMed 29772187Mazzocca 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.
PubMed 22336969
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Platelet -Rich Plasma in the Therapy of Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT03371888
- Acronym / sponsor ID
- PRP/TMD / Silesian MU PRP
- Conditions
- PRP, Temporomandibular Disorder, Myalgia, Bruxism
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- An intervention performed in experimental group and control group
| Arm | Type | Receives |
|---|---|---|
| PRP injections | Experimental | Biological: Platelet-Rich Plasma intramuscular injectionsIntramuscular injection of Platelet-Rich Plasma into the masseter and temporalis muscle |
| 0,9% NaCl injections | Placebo comparator | Biological: Placebo Comparator: 0,9% NaCl intramuscular injectionsIntramuscular injection of 0,9% NaCl into the masseter and temporalis muscle |
Who may qualify
- Ages
- 23 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
- patient's agreement for taking part into the research study
Key exclusion criteria (12 listed)
- patients being treated with or addicted to analgesic drugs and/or drugs that affect muscle function
- presence of contraindications for injection therapy
- patients being treated by neurologist for neurological disorders and/or neuropathic pain and/or headache
- patients after traumas to the head and neck region in the previous 2 years
- edentulous patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-Rich Plasma intramuscular injectionsAlso: PRP intramuscular injectionsA platelet-rich plasma intramuscular injections into the trigger points of painful muscles were performed. | Biological | PRP injections |
| Placebo Comparator: 0,9% NaCl intramuscular injectionsAlso: Saline intramuscular injectionsA 0,9% NaCl intramuscular injections into the trigger points of painful muscles were performed. | Biological | 0,9% NaCl injections |
Primary outcome
Pain intensity reduction in VAS scale,(VAS scale 0-10 points)
Time frame: 14 days
Decrease in pain intensity in masseter and temporalis muscles.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Background: PubMed 20140156Wright 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.
- Background: PubMed 25164150Xie 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.
- Background: PubMed 23759113Amable 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.
- Background: PubMed 26075269Salamanna 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.
- Background: PubMed 6307524Stiles CD. The molecular biology of platelet-derived growth factor. Cell. 1983 Jul;33(3):653-5. doi: 10.1016/0092-8674(83)90008-9.
- Background: PubMed 27011213Pihut 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.
- Background: PubMed 29772187Tsai 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.
- Background: PubMed 22336969Mazzocca 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandra Nitecka-Buchta, DMD principal investigator
Medical University of Silesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Platelet-Rich Plasma intramuscular injections in people with PRP and Temporomandibular Disorder, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity reduction in VAS scale,(VAS scale 0-10 points) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03371888, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.