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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5U/0,1 ml Botulinum toxin A | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Maximum jaw opening in millimeter, with and without pain will be compared to asess treatment outcomes. |
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Inclusion Criteria:
Patients will still be included even if they have one or more co-diagnoses
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veronica de Flon | Contact | + 46 702182623 | veronica.deflon@regionstockholm.se | |
| Hajer Jasim | Contact | hajer.jasim@reigionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Veronica de Flon | Region Stockholm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastman institute Folktandvården Region Stockholm | Recruiting | Stockholm | 11324 | Sweden |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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A randomized doubleblind single-center clinical trial.
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The preparation of the drugs and syringe is made by a research assistant.Preparation is performed immediately before the injection. The research assistant will hand over the syringe with the drug to be injected to the investigator to ensure that the patient and the investigator are blinded.
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|
| 10U/0,1 ml Botulinum toxin A | Drug | 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. |
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Treatment outcome in sub-groups of myogenous TMD. |
| 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. | 6 months |
| Changes in psychological factors | According to changes in Axis II (a psykometric form) | 6 months |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |