Temporomandibular DisorderPhase 3NCT06941636
Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders
A Phase 3 study testing 5U/0,1 ml Botulinum toxin A and 10U/0,1 ml Botulinum toxin A in people with Temporomandibular Disorder, run by Region Stockholm at 1 site in Sweden.
Trial summary
Both patients and remitters ask for treatment with Botulinumtoxin A (BTX) with the hope that it will be an effective aid for pain, but little is known regarding if the effect is dose dependent. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- 5U/0,1 ml Botulinum toxin A and 10U/0,1 ml Botulinum toxin A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2025to 1 Dec 2026
- Phase
- Phase 3
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Has given a written consent
- Diagnose of myalgia, myofacial pain or myofascial pain with referred pain according
- Average pain due to NRS ≥ 3 for more than three months
- Palpationpain in masseter or temporalis.
- Eventual treatment for orofacial pain > three months ago.
- Adequate contraceptives and a negative pregnancy test.
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- Patients will still be included even if they have one or more co-diagnoses
- Discdisplacement with or without reduction
- Degenerative joint disease
- Arthralgia
Who cannot join
- Treatment with BTX during the last 12 months
- Treatment for orofacial pain within the last 3 months.
- Systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis)
- Widespread pain e.g., fibromyalgia
- Neuropathic pain
- Neurologic disease (myasthenia gravis)
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- Pain of dental origin
- Use of muscle relaxants, or aminoglycoside antibiotics
- Pregnancy or nursing
- Hypersensitivity to BTX
- Neuropsychiatric conditions.
- Difficulties understanding the Swedish language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hajer Jasim contact
Sweden1 site, 1 recruiting
- Recruiting
Eastman institute Folktandvården Region Stockholm
Stockholm, 11324
Veronica de Flon, +46702182623, veronica.deflon@regionstockholm.se
About this study
Official title: Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders - a Quality Study Associated to a New Treatment Routine
Both patients and remitters ask for treatment with Botulinumtoxin A (BTX) with the hope that it will be an effective aid for pain, but little is known regarding if the effect is dose dependent.
The aim of this project is to investigate if injections with BTX in the masseter- and temporal muscle is an efficient treatment in patient with myogenous temporomandibular disorders (TMD) and if the effect of BTX is dose dependent.
Read the detailed description
The primary goal with this study is to expand treatment modalities for patient with myogenous TMD, and to develop clinical protocols with adequate doses for myogenous TMD. A secondary goal is to study if there are differences in treatment effect between sub-groups of myogenous TMD for more personalised pain-treatment.
Hypothesis The investigators hypothesis is that application of BTX into the masseter and temporalis muscle will reduce pain and increase quality of life in patients with myogenous TMD, and that the reduction of pain is only to a certain degree due to the dose. High doses of BTX does not necessarily entail increased reduction of pain or better quality of life. The investigators also hypotheses that the effect may differ in sub-groups of myogenous TMD.
- Conditions
- Temporomandibular Disorder
- Being tested
- 5U/0,1 ml Botulinum toxin A, 10U/0,1 ml Botulinum toxin A
- 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.
5U/0,1 ml Botulinum toxin ADrug
Also called Botox®100 U, AbbVie
Botox® 100 U (AbbVie) will be dissolved in 2 milliliters of room-temperature sterile isotonic saline, resulting in a solution concentration of 5 U/0.1 mL. Each patient will receive a total dose of 50 U, administered bilaterally into the masseter and temporalis muscles.
10U/0,1 ml Botulinum toxin ADrug
Also called Botox®100 U, AbbVie
Botox® 100 U (AbbVie) will be dissolved in 1 milliliters of room-temperature sterile isotonic saline, resulting in a solution concentration of 10 U/0.1 mL. Each patient will receive a total dose of 100 U, administered bilaterally into the masseter and temporalis muscles.
| Study group | Role | What they receive |
|---|---|---|
| BTX-L for myogenous TMD | Active comparator | Patients (n=45) with myogenious TMD will receive treatment with 50 U of Botox®100 U, AbbVie. The drug will be dissolved in 2 millilitres of room-temperate sterile isotonic saline. This gives 5U/0,1 ml solution and each patient will receive a total o 50 U as described in the protocol Receives: Drug: 5U/0,1 ml Botulinum toxin A |
| BTX-H for myogenous TMD | Active comparator | Patients (n=45) with myogenious TMD will receive treatment with 100 U of Botox®100 U, AbbVie. The drug will be dissolved in 1 millilitre of room-temperate sterile isotonic saline. This gives 10U/0,1 ml solution and each patient will receive a total of 100 U as described in the protocol Receives: Drug: 10U/0,1 ml Botulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain and impact of doses on pain relief
Pain level will be assessed using the Numeric rating Scale (NRS, a scale ranging from 0 (no pain) to 10 (worst pain imaginable). A 30% reduction in pain according to the NRS is considered a significant effect. The study compare two doses (low and high)
Measured: Six months
Secondary outcomes (4)
Changes in quality of life according to The Oral Healthy Impact profile questionnaire (OHIP-5)
The influence of the quality of life will be measured. Scores are categorized as follow: No influence (0-7 p), some influence (8-15 p) and large influence (16-20 p). Higher score mean worse outcomes
Measured: 6 months
Maximum jaw opening in millimeter, with and without pain will be compared to asess treatment outcomes.
Treatment outcome in sub-groups of myogenous TMD.
Measured: 6 months
Changes i pressure pain threshold (PPT)
Sensitivity to pressure induced pain by PPT (pressure pain threshold). PPT will be measured three times and average value will be used.
Measured: 6 months
Changes in psychological factors
According to changes in Axis II (a psykometric form)
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 posted24 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized doubleblind single-center clinical trial.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Veronica de Flon, Principal investigator, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941636
- Sponsor's protocol ID
- 2023-504033-44-00
- Other IDs
- 2023
- Status last verified
- Apr 2025
- First submitted
- 4 Jun 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders - a Quality Study Associated to a New Treatment Routine
- ClinicalTrials.gov ID
- NCT06941636
- Acronym / sponsor ID
- 2023-504033-44-00
- Conditions
- Temporomandibular Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Apr 2025 (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.
Both patients and remitters ask for treatment with Botulinumtoxin A (BTX) with the hope that it will be an effective aid for pain, but little is known regarding if the effect is dose dependent.
The aim of this project is to investigate if injections with BTX in the masseter- and temporal muscle is an efficient treatment in patient with myogenous temporomandibular disorders (TMD) and if the effect of BTX is dose dependent.
Detailed description
The primary goal with this study is to expand treatment modalities for patient with myogenous TMD, and to develop clinical protocols with adequate doses for myogenous TMD. A secondary goal is to study if there are differences in treatment effect between sub-groups of myogenous TMD for more personalised pain-treatment.
Hypothesis The investigators hypothesis is that application of BTX into the masseter and temporalis muscle will reduce pain and increase quality of life in patients with myogenous TMD, and that the reduction of pain is only to a certain degree due to the dose. High doses of BTX does not necessarily entail increased reduction of pain or better quality of life. The investigators also hypotheses that the effect may differ in sub-groups of myogenous TMD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- A randomized doubleblind single-center clinical trial.
| Arm | Type | Receives |
|---|---|---|
| BTX-L for myogenous TMD | Active comparator | Drug: 5U/0,1 ml Botulinum toxin APatients (n=45) with myogenious TMD will receive treatment with 50 U of Botox®100 U, AbbVie. The drug will be dissolved in 2 millilitres of room-temperate sterile isotonic saline. This gives 5U/0,1 ml solution and each patient will receive a total o 50 U as described in the protocol |
| BTX-H for myogenous TMD | Active comparator | Drug: 10U/0,1 ml Botulinum toxin APatients (n=45) with myogenious TMD will receive treatment with 100 U of Botox®100 U, AbbVie. The drug will be dissolved in 1 millilitre of room-temperate sterile isotonic saline. This gives 10U/0,1 ml solution and each patient will receive a total of 100 U as described in the protocol |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Has given a written consent
- Diagnose of myalgia, myofacial pain or myofascial pain with referred pain according
- Average pain due to NRS ≥ 3 for more than three months
- Palpationpain in masseter or temporalis.
- Eventual treatment for orofacial pain > three months ago.
Key exclusion criteria (12 listed)
- Treatment with BTX during the last 12 months
- Treatment for orofacial pain within the last 3 months.
- Systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis)
- Widespread pain e.g., fibromyalgia
- Neuropathic pain
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 |
|---|---|---|
| 5U/0,1 ml Botulinum toxin AAlso: Botox®100 U, AbbVieBotox® 100 U (AbbVie) will be dissolved in 2 milliliters of room-temperature sterile isotonic saline, resulting in a solution concentration of 5 U/0.1 mL. Each patient will receive a total dose of 50 U, administered bilaterally into the masseter and temporalis muscles. | Drug | BTX-L for myogenous TMD |
| 10U/0,1 ml Botulinum toxin AAlso: Botox®100 U, AbbVieBotox® 100 U (AbbVie) will be dissolved in 1 milliliters of room-temperature sterile isotonic saline, resulting in a solution concentration of 10 U/0.1 mL. Each patient will receive a total dose of 100 U, administered bilaterally into the masseter and temporalis muscles. | Drug | BTX-H for myogenous TMD |
Primary outcome
Changes in pain and impact of doses on pain relief
Time frame: Six months
Pain level will be assessed using the Numeric rating Scale (NRS, a scale ranging from 0 (no pain) to 10 (worst pain imaginable). A 30% reduction in pain according to the NRS is considered a significant effect. The study compare two doses (low and high)
4 secondary outcomes
Changes in quality of life according to The Oral Healthy Impact profile questionnaire (OHIP-5)
Time frame: 6 months
Maximum jaw opening in millimeter, with and without pain will be compared to asess treatment outcomes.
Time frame: 6 months
Changes i pressure pain threshold (PPT)
Time frame: 6 months
Changes in psychological factors
Time frame: 6 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 24 Apr 2025.
- 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.
Hajer Jasim contact
Veronica de Flon principal investigator
Region Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5U/0,1 ml Botulinum toxin A and 10U/0,1 ml Botulinum toxin A in people with Temporomandibular Disorder, run by Region Stockholm 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 10 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: looking for participants now, as of the sponsor's last update on 24 Apr 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
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 Veronica de Flon (+ 46 702182623, veronica.deflon@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain and impact of doses on pain relief (time frame: Six 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 24 Apr 2025.