Efficacy of botulinum toxin in treating temporomandibular disorders

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001597-16-FI

Enrollment

Registered

2018-05-15

Start date

2018-07-18

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients are diagnosed TMD (temporomandibular disorder) according to DC/TMD international consortium: myalgia, local myalgia, myofascial pain, myofascial pain with referral. MedDRA version: 20.0 Level: HLT Classification code 10028323 Term: Muscle pains System Organ Class: 100000004859

Interventions

Trade Name: Xeomin Product Name: Botulinum toxin A Pharmaceutical Form: Injection CAS Number: 93384-43-1 Other descriptive name: BOTULINUM TOXIN TYPE A Concentration unit: U unit(s) Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -60 adult patient (males and females) diagnosed TMD according to DC/TMD international consortium: myalgia, local myalgia, myofascial pain, myofascial pain with referral. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Subjects are not receiving any other TMD-treatments and from the previous BTX treatment should have been at least 6 months passed -Other disturbing factors such as CNS drugs, alcoholism, heavy smoking, mental illness, diseases that might cause imbalance of the joint will be excluded -No pregnant women

Design outcomes

Primary

Measure	Time frame
Main Objective: -To evaluate subjective and objective parameters for pain and jaw function during the BTX-A treatment of masticatory muscles -To identify demographic and diagnostic characteristics that would predict the clinical outcome of the therapy. -To determine the efficacy and safety of the treatment;Secondary Objective: no applicable;Primary end point(s): To reduce myofacial pain and improve jaw function;Timepoint(s) of evaluation of this end point: Botulinum toxin A injection causes relaxation of the muscle that starts during 7-13 days and lasts for 3-6 months	—

Measure

Time frame

Main Objective: -To evaluate subjective and objective parameters for pain and jaw function during the BTX-A treatment of masticatory muscles -To identify demographic and diagnostic characteristics that would predict the clinical outcome of the therapy. -To determine the efficacy and safety of the treatment;Secondary Objective: no applicable;Primary end point(s): To reduce myofacial pain and improve jaw function;Timepoint(s) of evaluation of this end point: Botulinum toxin A injection causes relaxation of the muscle that starts during 7-13 days and lasts for 3-6 months

—

Secondary

Measure	Time frame
Secondary end point(s): no applicable;Timepoint(s) of evaluation of this end point: no applicable	—

Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026