Myogenic Temporomandibular Joint DisordersNCT07606378
Efficacy of PRP Injections in Reducing Pain for Myogenous TMD Patients
A study testing Saline (0.9% NaCl) and Platelet rich plasma (PRP) in people with Myogenic Temporomandibular Joint Disorders and Myofacial Pain, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This study aims to evaluate whether intramuscular injections of platelet-rich plasma (PRP) are more effective than isotonic saline in reducing pain and improving jaw function in individuals diagnosed with myogenous temporomandibular disorders (TMD). Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Myogenic Temporomandibular Joint Disorders, Myofacial Pain, Masseter Muscle
- What is being tested?
- Saline (0.9% NaCl) and Platelet rich plasma (PRP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 4 Aug 2026to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women 20 to 50 years with a confirmed diagnosis of myogenous TMD according to the DC/TMD
- participants must have pain in the masticatory muscles
- pain duration must be at least 3 months
- participants must report current pain at the day of inclusion with a minimum score of 4 on the numeric rating scale (NRS 0 to 10)
Who cannot join
- active infection or inflammation at the injection site
- systemic infection
- platelet or coagulation disorders
- severe anemia;
- autoimmune or inflammatory rheumatic disease;
- chronic liver diseases;
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- uncontrolled diabetes;
- pregnancy or breastfeeding will also be exclusion criteria
- individuals using anticoagulant or antiplatelet medication that cannot be temporarily discontinued or receiving chronic corticosteroid or immunosuppressive therapy
- predominantly arthralgia temporomandibular disorders
- previous temporomandibular joint surgery, or a history of significant trauma to the face, head, or neck, including orthognathic surgery
- individuals with fibromyalgia
- individuals with neuromuscular disorders such as craniomandibular dystonia or myasthenia gravis, diagnosed or severe psychiatric disease such as schizophrenia or bipolar disorder, neuropathic pain, or pain of dental origin
- individuals unable to provide informed consent or complete study questionnaires will be excluded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Karolinska Institutet - Department of Dental Medicine
Huddinge, Stockholm County, 17177
About this study
Official title: Platelet-Rich Plasma (PRP) Injections as Treatment for Myogenous Temporomandibular Disorders: A Randomized Clinical Trial
This study aims to evaluate whether intramuscular injections of platelet-rich plasma (PRP) are more effective than isotonic saline in reducing pain and improving jaw function in individuals diagnosed with myogenous temporomandibular disorders (TMD). Myogenous TMD is a common source of orofacial muscle pain and functional limitation, and although conservative treatments help many patients, a significant proportion continue to experience persistent symptoms that affect daily life and quality of function.
PRP is an autologous, minimally invasive biologic concentrate enriched with platelets and bioactive molecules that may promote tissue repair and modulate inflammation, making it a promising option for managing muscle-related pain conditions. However, evidence from well-controlled randomized clinical trials in myogenous TMD remains limited.
Read more
In this double-blind, randomized controlled clinical trial, participants will receive two intramuscular injections-either PRP or saline-administered one month apart. Follow-up assessments will occur at 1, 3, and 6 months using standardized and validated measures of pain intensity, pain sensitivity, mandibular function, and psychosocial factors.
The results of this study may help determine the clinical value of PRP for myogenous TMD and contribute to future standardization of regenerative treatment protocols in orofacial pain management.
- Being tested
- Saline (0.9% NaCl), Platelet rich plasma (PRP)
- Keywords
- Temporomandibuar disorders, Myogenous TMD, Myofascial Pain, Orofacial Pain, Masseter Muscle, Platelet-Rich Plasma, PRP Injection, Regenerative Therapy, Intramuscular Injection, Pain Modulation
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline (0.9% NaCl)Drug
Participants in this arm will receive intramuscular injections of isotonic 0.9% saline into the masseter muscles. The injection technique, number of points (three per masseter), volume per point (0.3 mL), and needle type are identical to the PRP arm to maintain procedural consistency. A second saline injection will be administered at the 1-month follow-up visit. All proce
Platelet rich plasma (PRP)Procedure or surgery
PRP Injection (Experimental)
Participants in this arm will receive intramuscular injections of platelet-rich plasma (PRP) into the masseter muscles. PRP is prepared using a standardized two-step centrifugation protocol to obtain the platelet-rich fraction. Each session includes injections at three marked points per masseter muscle, with 0.3 mL injected per point (total 1.8 mL per session). A second PRP injection will be administered at the 1-month follow-up visit. All procedures are performed under double-blind conditions.
| Study group | Role | What they receive |
|---|---|---|
| PRP Injection | Experimental | PRP Injection (Experimental)
Arm Description:
Participants in this arm will receive intramuscular injections of platelet-rich plasma (PRP) into the masseter muscles. PRP is prepared using a standardized two-step centrifugation protocol to obtain the platelet-rich fraction. Each session includes injections at three marked points per masseter muscle, with 0.3 mL injected per point (total 1.8 mL per session). A second PRP injection will be administered at the 1-month follow-up visit. All procedures are performed under double-blind conditions. Receives: Procedure: Platelet rich plasma (PRP) |
| Saline Injection | Placebo comparator | Saline Injection (Placebo Comparator)
Arm Description:
Participants in this arm will receive intramuscular injections of isotonic 0.9% saline into the masseter muscles. The injection technique, number of points (three per masseter), volume per point (0.3 mL), and needle type are identical to the PRP arm to maintain procedural consistency. A second saline injection will be administered at the 1-month follow-up visit. All proc Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity (CPI 0-100)
Change in self-reported pain intensity , measured using a 0-100 Characteristic Pain Intensity (CPI). The assessment will be perform at baseline and at each follow-up.
Measured: Baseline, 1 month, 3 months
Secondary outcomes (1)
Change in Maximum Mouth Opening (MMO)
Change in maximum unassisted mouth opening in millimeters, measured using a standardized ruler. Higher values indicate improved mandibular mobility
Measured: Baseline, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start4 Aug 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myogenic Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaos Christidis, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606378
- Sponsor's protocol ID
- 2026-01518-01
- Other IDs
- Karolinska Institutet
- Status last verified
- Aug 2026
- First submitted
- 19 May 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-Rich Plasma (PRP) Injections as Treatment for Myogenous Temporomandibular Disorders: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07606378
- Acronym / sponsor ID
- 2026-01518-01
- Keywords
- Temporomandibuar disorders, Myogenous TMD, Myofascial Pain, Orofacial Pain, Masseter Muscle, Platelet-Rich Plasma, PRP Injection, Regenerative Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 4 Aug 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 26 May 2026 (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.
This study aims to evaluate whether intramuscular injections of platelet-rich plasma (PRP) are more effective than isotonic saline in reducing pain and improving jaw function in individuals diagnosed with myogenous temporomandibular disorders (TMD). Myogenous TMD is a common source of orofacial muscle pain and functional limitation, and although conservative treatments help many patients, a significant proportion continue to experience persistent symptoms that affect daily life and quality of function.
PRP is an autologous, minimally invasive biologic concentrate enriched with platelets and bioactive molecules that may promote tissue repair and modulate inflammation, making it a promising option for managing muscle-related pain conditions. However, evidence from well-controlled randomized clinical trials in myogenous TMD remains limited.
In this double-blind, randomized controlled clinical trial, participants will receive two intramuscular injections-either PRP or saline-administered one month apart. Follow-up assessments will occur at 1, 3, and 6 months using standardized and validated measures of pain intensity, pain sensitivity, mandibular function, and psychosocial factors.
The results of this study may help determine the clinical value of PRP for myogenous TMD and contribute to future standardization of regenerative treatment protocols in orofacial pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP Injection | Experimental | Procedure: Platelet rich plasma (PRP)PRP Injection (Experimental) Arm Description: Participants in this arm will receive intramuscular injections of platelet-rich plasma (PRP) into the masseter muscles. PRP is prepared using a standardized two-step centrifugation protocol to obtain the platelet-rich fraction. Each session includes injections at three marked points per masseter muscle, with 0.3 mL injected per point (total 1.8 mL per session). A second PRP injection will be administered at the 1-month follow-up visit. All procedures are performed under double-blind conditions. |
| Saline Injection | Placebo comparator | Drug: Saline (0.9% NaCl)Saline Injection (Placebo Comparator) Arm Description: Participants in this arm will receive intramuscular injections of isotonic 0.9% saline into the masseter muscles. The injection technique, number of points (three per masseter), volume per point (0.3 mL), and needle type are identical to the PRP arm to maintain procedural consistency. A second saline injection will be administered at the 1-month follow-up visit. All proc |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women 20 to 50 years with a confirmed diagnosis of myogenous TMD according to the DC/TMD
- participants must have pain in the masticatory muscles
- pain duration must be at least 3 months
- participants must report current pain at the day of inclusion with a minimum score of 4 on the numeric rating scale (NRS 0 to 10)
Key exclusion criteria (14 listed)
- active infection or inflammation at the injection site
- systemic infection
- platelet or coagulation disorders
- severe anemia;
- autoimmune or inflammatory rheumatic disease;
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 |
|---|---|---|
| Saline (0.9% NaCl)Participants in this arm will receive intramuscular injections of isotonic 0.9% saline into the masseter muscles. The injection technique, number of points (three per masseter), volume per point (0.3 mL), and needle type are identical to the PRP arm to maintain procedural consistency. A second saline injection will be administered at the 1-month follow-up visit. All proce | Drug | Saline Injection |
| Platelet rich plasma (PRP)PRP Injection (Experimental) Participants in this arm will receive intramuscular injections of platelet-rich plasma (PRP) into the masseter muscles. PRP is prepared using a standardized two-step centrifugation protocol to obtain the platelet-rich fraction. Each session includes injections at three marked points per masseter muscle, with 0.3 mL injected per point (total 1.8 mL per session). A second PRP injection will be administered at the 1-month follow-up visit. All procedures are performed under double-blind conditions. | Procedure or surgery | PRP Injection |
Primary outcome
Change in Pain Intensity (CPI 0-100)
Time frame: Baseline, 1 month, 3 months
Change in self-reported pain intensity , measured using a 0-100 Characteristic Pain Intensity (CPI). The assessment will be perform at baseline and at each follow-up.
1 secondary outcome
Change in Maximum Mouth Opening (MMO)
Time frame: Baseline, 1 month, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline (0.9% NaCl) and Platelet rich plasma (PRP) in people with Myogenic Temporomandibular Joint Disorders and Myofacial Pain, run by Karolinska Institutet at 1 site in Sweden.
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 4 inclusion and 14 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: opening soon, as of the sponsor's last update on 5 Aug 2026. 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 Sweden. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikolaos Christidis Professor, PhD (+4685288124, nikolaos.christidis@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (CPI 0-100) (time frame: Baseline, 1 month, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.