A Phase 3 interventional study of 5U/0,1 ml Botulinum toxin A and 10U/0,1 ml Botulinum toxin A in Temporomandibular Disorder, sponsored by Region Stockholm. Recruiting at 1 site in Sweden. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Region Stockholm · Phase 3, Interventional, and Other
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Among 11 studies in Temporomandibular Joint Disorders with a site in Sweden — 7 open to participants now, 7 under way, 1 of them phase 3. Temporomandibular Joint Disorders · Sweden.
Among the 11 studies in Temporomandibular Joint Disorders with a site in Sweden, this one is one of 4 that started in 2025, is the only one in phase 3, and was the 7th registered.
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
Browse Temporomandibular Joint Disorders studies →7 of the 11 studies in Temporomandibular Joint Disorders with a site in Sweden are open now. Recruiting first, the newest first:
Lund University Hospital · Sites in Sweden
Karolinska Institutet · Sites in Sweden
Ages 18+
Karolinska Institutet · Sites in Sweden
Ages 18+
Karolinska Institutet · Sites in Sweden
Ages 18+
Karolinska Institutet · Sites in Sweden
Ages 20–45
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 75 Temporomandibular Joint Disorders studies recruiting now, 26 (35%) set no upper age limit and 45 (60%) stop at 75 or younger; 7 take children under 18; 23 take healthy volunteers.
This study: 18 Years to 50 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 90 is above the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.
Median enrollment 90 across the 7 interventional studies, 96 across the 4 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
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None of the 11 has an industry lead sponsor. The 4 most frequent:
Region Stockholm is the lead sponsor of 121 studies on the registry; 69 are open to participants now.
Region Stockholm has 1 study filed under Temporomandibular Joint Disorders — fewer than ten, so there is no comparison to draw.
4 of the studies in Temporomandibular Joint Disorders with a site in Sweden that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06941636Phase 3Region StockholmBotulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders | 2026-12-01 |
| NCT06782165Karolinska InstitutetLong-term Follow up of TMJ Surgery and Evaluation of the 6-month Control as a Prognostic Marker. | 2027-02 |
| NCT07373184Lund University HospitalVirtual Planning of Total Temporomandibular Joint Replacement | 2027-06-30 |
| NCT05720065Karolinska InstitutetPeripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A | 2027-08-31 |
Add all 4 to your calendar (.ics) → With an account.
Among the 11 studies in Temporomandibular Joint Disorders with a site in Sweden, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients will still be included even if they have one or more co-diagnoses
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: 5U/0,1 ml Botulinum toxin A
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
Drug: 10U/0,1 ml Botulinum toxin A
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.
Also known as: 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.
Also known as: Botox®100 U, AbbVie
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)
Time frame: Six months
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
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Changes in psychological factors
According to changes in Axis II (a psykometric form)
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Dec 2026, 19 months later.
How these figures are worked out, and which studies are left out of them.
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Temporomandibular Joint Disorders →