Temporomandibular DisorderNCT04127942
Platelet-rich Plasma Injection for Temporomandibular Disorders
A study testing platelet-rich plasma injection therapy of TMD in people with Temporomandibular Disorder, run by Tri-Service General Hospital (TSGH).
Trial summary
Temporomandibular disorder (TMD) involves the temporomandibular joint (TMJ) and surrounding structure, causing problems including myofascial pain and joint degeneration. TMD is mostly seen in the age group of 18 to 44. TMD treatment includes conservative (non-surgical) and surgical treatment. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- platelet-rich plasma injection therapy of TMD
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 30 Apr 2020
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 20-80 year-old.
- Duration of symptoms ( temporomandibular joint pain or tenderness, joint noise or joint motility dysfunction)more than 3 months.
- Diagnosis was confirmed by using the original Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) and the severity at least Grade II.
Who cannot join
- Head and neck cancer
- Neurological disease
- Cognition impairment
- Coagulopathy
- Pregnancy
- Inflammation status
- Infection status
- Previously undergone wrist surgery or steroid injection for TMD
About this study
Official title: Six-month Efficacy of Ultrasound-guided Platelet-rich Plasma Injection for Temporomandibular Disorders
Temporomandibular disorder (TMD) involves the temporomandibular joint (TMJ) and surrounding structure, causing problems including myofascial pain and joint degeneration. TMD is mostly seen in the age group of 18 to 44. TMD treatment includes conservative (non-surgical) and surgical treatment. Surgical TMD treatment has a decent success rate but requires general anesthesia, hospital stay and surgical incision. There are also some risks of facial nerve and vascular damage, infection, puncture to middle cranial fossa. Conservative treatments include medication , physical therapy, use of occlusal splint, hyaluronic acid (HA) or Botulinum toxin injection and concentrated glucose solution. However, those managements lack the evidence from large placebo-controlled clinical trials. Therefore, the development of novel non-surgical treatment is important and of great potential. The ultrasound guidance provides visualization of the lesion site, allowing the operator to provide injection precisely and avoid damage on adjacent tissue, nerves and vessels. it is not only convenient and economic, but also associated with significantly less radiation exposure than conventional techniques such as computer tomography or fluoroscopy. Using ultrasound guidance in injective TMD treatment can increase successful rate and prevent unnecessary side effects. While current available evidences suggest the promising effect of platelet-rich plasma (PRP) injection therapy in treating TMD, publication of study with strict design is still lacking. Therefore, this study is a randomized, controlled and double-blind design, which aimed to access the efficacy of ultrasound-guided PRP injection therapy of TMD, with normal saline used as control. Looking forward to establish TMD clinical treatment guideline in the future.
Read the detailed description
Objectives:
Temporomandibular disorder (TMD) involves the temporomandibular joint (TMJ) and surrounding structure, causing problems including myofascial pain and joint degeneration. TMD is mostly seen in the age group of 18 to 44. TMD treatment includes conservative (non-surgical) and surgical treatment. Surgical TMD treatment has a decent success rate but requires general anesthesia, hospital stay and surgical incision. There are also some risks of facial nerve and vascular damage, infection, puncture to middle cranial fossa. Conservative treatments include medication , physical therapy, use of occlusal splint, hyaluronic acid (HA) or Botulinum toxin injection and concentrated glucose solution. However, those managements lack the evidence from large placebo-controlled clinical trials. Therefore, the development of novel non-surgical treatment is important and of great potential. The ultrasound guidance provides visualization of the lesion site, allowing the operator to provide injection precisely and avoid damage on adjacent tissue, nerves and vessels. it is not only convenient and economic, but also associated with significantly less radiation exposure than conventional techniques such as computer tomography or fluoroscopy. Using ultrasound guidance in injective TMD treatment can increase successful rate and prevent unnecessary side effects. While current available evidences suggest the promising effect of platelet-rich plasma (PRP) injection therapy in treating TMD, publication of study with strict design is still lacking. Therefore, this study is a randomized, controlled and double-blind design, which aimed to access the efficacy of ultrasound-guided PRP injection therapy of TMD, with normal saline used as control. Looking forward to establish TMD clinical treatment guideline in the future.
Methods:
The out-patients with unilateral or bilateral TMD、joint mobility dysfunction or joint noise from this hospital were enrolled. They were randomized via computer into 2 groups (PRP group and normal saline group). There are 30 patients in each group. The PRP group received 1cc PRP injection in the superior temporomandibular disk joint space by ultrasound guidance. The normal saline group received the same procedure as PRP group with 1 cc normal saline injection. Both group received the same protocol of physical therapy (manual therapy, stretching exercise, posture training with 30 minutes per session and 2 sessions per weeks) for 12 weeks. Those physical therapies were under the guidance of one therapist who didn't know the patient's allocation.
The investigator and subjects did not know the group assignment. Evaluations were performed at time points prior to injection and 2 weeks, 1st, 3rd , and 6th months post injection by one doctor (who didn't know about the group assignment). Evaluations include Visual Analogue Scale (VAS) of the degree of pain, masticatory efficiency, perceived joint noise and measure of maximal interincisal opening, painless oral opening, mandibular lateral movement and protrusion movement. The investigator also evaluated symptoms or signs of side effects and complications.
Besides, the subjects can't receive any treatment include medications or injection for pain control, but allowed to take Acetaminophen 500mg, maximal dosage 4g per day to relieve refractory pain during follow up period. If any participant broke the rules or took Acetaminophen over daily dosage, the participant will be excluded to this study.
- Conditions
- Temporomandibular Disorder
- Being tested
- platelet-rich plasma injection therapy of TMD
- Keywords
- platelet-rich plasma, ultrasound guided injection., Temporomandibular disorder
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet-rich plasma injection therapy of TMDProcedure or surgery
The administer injected 1cc PRP in the superior temporomandibular disk joint space by ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| platelet-rich plasma injection | Experimental | 1cc platelet-rich plasma(PRP) injection in the superior temporomandibular disk joint space by ultrasound guidance. Receives: Procedure: platelet-rich plasma injection therapy of TMD |
| normal saline injection | Placebo comparator | 1cc normal saline injection in the superior temporomandibular disk joint space by ultrasound guidance. Receives: Procedure: platelet-rich plasma injection therapy of TMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) of the degree of pain
*. Visual Analogue Scale of the degree of pain: with the score ranging from 10 (tremendous pain) to 0 (no pain).
Measured: 6 months
Secondary outcomes (4)
measure of maximal interincisal opening and painless mouth opening
The subject was instructed, "Open your mouth as wide as possible without causing pain or discomfort." Then, using ruler to measured the intercisal distance (cm) by placing the ruler between central incisors.
Measured: 6 months
measure of maximal mandibular excursion and protrusion.
- Excursion: Vertical marks were made on the anterior surface of the lower central incisors in relationship to the upper central incisors and the subject was instructed to "move your jaw as far to the side as you can comfortably." The measurement was taken as the horizontal distance between the 2 marks when the jaw was moved to the left and the right by using ruler to measured the intercisal distance (cm)
- Protrusion: Two vertical lines were made on the first upper and lower canine incisors. The subject was instructed to "move your jaw as far forward as you can." The measurement was taken as the distance between the 2 marks by using ruler to measured the intercisal distance (cm)
Measured: 6 months
Visual Analogue Scale of masticatory efficiency
*. Visual Analogue Scale of masticatory efficiency:with the score ranging from 10 (good; can eat solid food) to 0 (poor; only liquid diet)
Measured: 6 months
Visual Analogue Scale of perceived joint noise
*. Visual Analogue Scale of perceived joint noise: with the score ranging from 10 (much noise) to 0 (no noise).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Why it stopped: no sufficient enrolled pateints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- access the efficacy of ultrasound-guided PRP injection therapy of TMD, with normal saline used as control group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang-Cheng Chen, Tri-Service General Hospital (TSGH)
- Investigators
- Liang-Cheng Chen, MD,MS, Principal investigator, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127942
- Sponsor's protocol ID
- 2-106-05-026
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2019
- Last updated
- 27 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cooper BC, Kleinberg I. Examination of a large patient population for the presence of symptoms and signs of temporomandibular disorders. Cranio. 2007 Apr;25(2):114-26. doi: 10.1179/crn.2007.018.
PubMed 17508632Gencer ZK, Ozkiris M, Okur A, Korkmaz M, Saydam L. A comparative study on the impact of intra-articular injections of hyaluronic acid, tenoxicam and betametazon on the relief of temporomandibular joint disorder complaints. J Craniomaxillofac Surg. 2014 Oct;42(7):1117-21. doi: 10.1016/j.jcms.2014.01.041. Epub 2014 Feb 4.
PubMed 24853591Martins WR, Blasczyk JC, Aparecida Furlan de Oliveira M, Lagoa Goncalves KF, Bonini-Rocha AC, Dugailly PM, de Oliveira RJ. Efficacy of musculoskeletal manual approach in the treatment of temporomandibular joint disorder: A systematic review with meta-analysis. Man Ther. 2016 Feb;21:10-7. doi: 10.1016/j.math.2015.06.009. Epub 2015 Jun 25.
PubMed 26144684Kummoona R. Surgical managements of subluxation and dislocation of the temporomandibular joint: clinical and experimental studies. J Craniofac Surg. 2010 Nov;21(6):1692-7. doi: 10.1097/SCS.0b013e3181f3c682.
PubMed 21119402Sivri MB, Ozkan Y, Pekiner FN, Gocmen G. Comparison of ultrasound-guided and conventional arthrocentesis of the temporomandibular joint. Br J Oral Maxillofac Surg. 2016 Jul;54(6):677-81. doi: 10.1016/j.bjoms.2016.04.004. Epub 2016 Apr 23.
PubMed 27118616Fernandez-Ferro M, Fernandez-Sanroman J, Blanco-Carrion A, Costas-Lopez A, Lopez-Betancourt A, Arenaz-Bua J, Stavaru Marinescu B. Comparison of intra-articular injection of plasma rich in growth factors versus hyaluronic acid following arthroscopy in the treatment of temporomandibular dysfunction: A randomised prospective study. J Craniomaxillofac Surg. 2017 Apr;45(4):449-454. doi: 10.1016/j.jcms.2017.01.010. Epub 2017 Jan 25.
PubMed 28237253
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Six-month Efficacy of Ultrasound-guided Platelet-rich Plasma Injection for Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT04127942
- Acronym / sponsor ID
- 2-106-05-026
- Conditions
- Temporomandibular Disorder
- Keywords
- platelet-rich plasma, ultrasound guided injection., Temporomandibular disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no sufficient enrolled pateints
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 16 Oct 2019 (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.
Temporomandibular disorder (TMD) involves the temporomandibular joint (TMJ) and surrounding structure, causing problems including myofascial pain and joint degeneration. TMD is mostly seen in the age group of 18 to 44. TMD treatment includes conservative (non-surgical) and surgical treatment. Surgical TMD treatment has a decent success rate but requires general anesthesia, hospital stay and surgical incision. There are also some risks of facial nerve and vascular damage, infection, puncture to middle cranial fossa. Conservative treatments include medication , physical therapy, use of occlusal splint, hyaluronic acid (HA) or Botulinum toxin injection and concentrated glucose solution. However, those managements lack the evidence from large placebo-controlled clinical trials. Therefore, the development of novel non-surgical treatment is important and of great potential. The ultrasound guidance provides visualization of the lesion site, allowing the operator to provide injection precisely and avoid damage on adjacent tissue, nerves and vessels. it is not only convenient and economic, but also associated with significantly less radiation exposure than conventional techniques such as computer tomography or fluoroscopy. Using ultrasound guidance in injective TMD treatment can increase successful rate and prevent unnecessary side effects. While current available evidences suggest the promising effect of platelet-rich plasma (PRP) injection therapy in treating TMD, publication of study with strict design is still lacking. Therefore, this study is a randomized, controlled and double-blind design, which aimed to access the efficacy of ultrasound-guided PRP injection therapy of TMD, with normal saline used as control. Looking forward to establish TMD clinical treatment guideline in the future.
Detailed description
Objectives:
Temporomandibular disorder (TMD) involves the temporomandibular joint (TMJ) and surrounding structure, causing problems including myofascial pain and joint degeneration. TMD is mostly seen in the age group of 18 to 44. TMD treatment includes conservative (non-surgical) and surgical treatment. Surgical TMD treatment has a decent success rate but requires general anesthesia, hospital stay and surgical incision. There are also some risks of facial nerve and vascular damage, infection, puncture to middle cranial fossa. Conservative treatments include medication , physical therapy, use of occlusal splint, hyaluronic acid (HA) or Botulinum toxin injection and concentrated glucose solution. However, those managements lack the evidence from large placebo-controlled clinical trials. Therefore, the development of novel non-surgical treatment is important and of great potential. The ultrasound guidance provides visualization of the lesion site, allowing the operator to provide injection precisely and avoid damage on adjacent tissue, nerves and vessels. it is not only convenient and economic, but also associated with significantly less radiation exposure than conventional techniques such as computer tomography or fluoroscopy. Using ultrasound guidance in injective TMD treatment can increase successful rate and prevent unnecessary side effects. While current available evidences suggest the promising effect of platelet-rich plasma (PRP) injection therapy in treating TMD, publication of study with strict design is still lacking. Therefore, this study is a randomized, controlled and double-blind design, which aimed to access the efficacy of ultrasound-guided PRP injection therapy of TMD, with normal saline used as control. Looking forward to establish TMD clinical treatment guideline in the future.
Methods:
The out-patients with unilateral or bilateral TMD、joint mobility dysfunction or joint noise from this hospital were enrolled. They were randomized via computer into 2 groups (PRP group and normal saline group). There are 30 patients in each group. The PRP group received 1cc PRP injection in the superior temporomandibular disk joint space by ultrasound guidance. The normal saline group received the same procedure as PRP group with 1 cc normal saline injection. Both group received the same protocol of physical therapy (manual therapy, stretching exercise, posture training with 30 minutes per session and 2 sessions per weeks) for 12 weeks. Those physical therapies were under the guidance of one therapist who didn't know the patient's allocation.
The investigator and subjects did not know the group assignment. Evaluations were performed at time points prior to injection and 2 weeks, 1st, 3rd , and 6th months post injection by one doctor (who didn't know about the group assignment). Evaluations include Visual Analogue Scale (VAS) of the degree of pain, masticatory efficiency, perceived joint noise and measure of maximal interincisal opening, painless oral opening, mandibular lateral movement and protrusion movement. The investigator also evaluated symptoms or signs of side effects and complications.
Besides, the subjects can't receive any treatment include medications or injection for pain control, but allowed to take Acetaminophen 500mg, maximal dosage 4g per day to relieve refractory pain during follow up period. If any participant broke the rules or took Acetaminophen over daily dosage, the participant will be excluded to this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- access the efficacy of ultrasound-guided PRP injection therapy of TMD, with normal saline used as control group.
| Arm | Type | Receives |
|---|---|---|
| platelet-rich plasma injection | Experimental | Procedure: platelet-rich plasma injection therapy of TMD1cc platelet-rich plasma(PRP) injection in the superior temporomandibular disk joint space by ultrasound guidance. |
| normal saline injection | Placebo comparator | Procedure: platelet-rich plasma injection therapy of TMD1cc normal saline injection in the superior temporomandibular disk joint space by ultrasound guidance. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 20-80 year-old.
- Duration of symptoms ( temporomandibular joint pain or tenderness, joint noise or joint motility dysfunction)more than 3 months.
- Diagnosis was confirmed by using the original Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) and the severity at least Grade II.
Key exclusion criteria (8 listed)
- Head and neck cancer
- Neurological disease
- Cognition impairment
- Coagulopathy
- Pregnancy
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 injection therapy of TMDThe administer injected 1cc PRP in the superior temporomandibular disk joint space by ultrasound guidance. | Procedure or surgery | normal saline injection, platelet-rich plasma injection |
Primary outcome
Visual Analogue Scale (VAS) of the degree of pain
Time frame: 6 months
*. Visual Analogue Scale of the degree of pain: with the score ranging from 10 (tremendous pain) to 0 (no pain).
4 secondary outcomes
measure of maximal interincisal opening and painless mouth opening
Time frame: 6 months
measure of maximal mandibular excursion and protrusion.
Time frame: 6 months
Visual Analogue Scale of masticatory efficiency
Time frame: 6 months
Visual Analogue Scale of perceived joint noise
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Background: PubMed 17508632Cooper BC, Kleinberg I. Examination of a large patient population for the presence of symptoms and signs of temporomandibular disorders. Cranio. 2007 Apr;25(2):114-26. doi: 10.1179/crn.2007.018.
- Background: PubMed 24853591Gencer ZK, Ozkiris M, Okur A, Korkmaz M, Saydam L. A comparative study on the impact of intra-articular injections of hyaluronic acid, tenoxicam and betametazon on the relief of temporomandibular joint disorder complaints. J Craniomaxillofac Surg. 2014 Oct;42(7):1117-21. doi: 10.1016/j.jcms.2014.01.041. Epub 2014 Feb 4.
- Background: PubMed 26144684Martins WR, Blasczyk JC, Aparecida Furlan de Oliveira M, Lagoa Goncalves KF, Bonini-Rocha AC, Dugailly PM, de Oliveira RJ. Efficacy of musculoskeletal manual approach in the treatment of temporomandibular joint disorder: A systematic review with meta-analysis. Man Ther. 2016 Feb;21:10-7. doi: 10.1016/j.math.2015.06.009. Epub 2015 Jun 25.
- Background: PubMed 21119402Kummoona R. Surgical managements of subluxation and dislocation of the temporomandibular joint: clinical and experimental studies. J Craniofac Surg. 2010 Nov;21(6):1692-7. doi: 10.1097/SCS.0b013e3181f3c682.
- Background: PubMed 27118616Sivri MB, Ozkan Y, Pekiner FN, Gocmen G. Comparison of ultrasound-guided and conventional arthrocentesis of the temporomandibular joint. Br J Oral Maxillofac Surg. 2016 Jul;54(6):677-81. doi: 10.1016/j.bjoms.2016.04.004. Epub 2016 Apr 23.
- Background: PubMed 28237253Fernandez-Ferro M, Fernandez-Sanroman J, Blanco-Carrion A, Costas-Lopez A, Lopez-Betancourt A, Arenaz-Bua J, Stavaru Marinescu B. Comparison of intra-articular injection of plasma rich in growth factors versus hyaluronic acid following arthroscopy in the treatment of temporomandibular dysfunction: A randomised prospective study. J Craniomaxillofac Surg. 2017 Apr;45(4):449-454. doi: 10.1016/j.jcms.2017.01.010. Epub 2017 Jan 25.
- 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.
Liang-Cheng Chen, MD,MS principal investigator
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing platelet-rich plasma injection therapy of TMD in people with Temporomandibular Disorder, run by Tri-Service General Hospital (TSGH).
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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Visual Analogue Scale (VAS) of the degree of pain (time frame: 6 months). 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 NCT04127942, which also lists 6 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 27 Apr 2020.