Treatment of headache attributed to temporomandibular disorder with a flat plane occlusal splint and injections of botulinum toxin

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001912-31-SI

Enrollment

120

Registered

2018-11-20

Start date

2019-12-09

Completion date

Unknown

Last updated

2024-12-16

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

Conditions

Headache attributed to temporomandibular disorder

Interventions

Trade Name: XEOMIN 100 units powder for solution for injection Product Name: Botox Pharmaceutical Form: Powder for suspension for injection Pharmaceutical form of the placebo: Solution for solution fo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Headache attributed to TMD 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 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Systemic rheumatic, neurological / neuropathic, endocrine or immune / autoimmune disease or enlarged pain (except rheumatoid arthritis in fibromyalgia). • Radiation in the head area of the neck • Surgical intervention in the TMS area • Trauma in the jaw area over the past 2 months (car accident anytime - absolute exclusion factor). • Presence of oral pain, other than TMM • Pregnancy • Neurological disorders • Inability to participate in research (physical, mental or language barriers) • Use of narcotics, muscle relaxants or steroids, unless it was discontinued 1 week before the survey • Use of antidepressants unless the patient is on stable doses for 60 days • Use of NSAIDs unless the patient discontinues taking at least 3 days prior to the study • Drug abuse • The patient is in the process of treatment with a dentist • TMM therapy unless the patient has been on stable therapies for the last two months • Patient not consent for trial

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of the study is to determine whether the treatment with the stabilization splint and injections of botulinum toxin is effective in treating headache attributed to temporomandibular disorders.;Secondary Objective: Not applicable;Primary end point(s): The results of the research will be the basis for introducing guidelines for the treatment of headache attributed to TMD.;Timepoint(s) of evaluation of this end point: 1 year	—

Measure

Time frame

Main Objective: The purpose of the study is to determine whether the treatment with the stabilization splint and injections of botulinum toxin is effective in treating headache attributed to temporomandibular disorders.;Secondary Objective: Not applicable;Primary end point(s): The results of the research will be the basis for introducing guidelines for the treatment of headache attributed to TMD.;Timepoint(s) of evaluation of this end point: 1 year

—

Secondary

Measure	Time frame
Secondary end point(s): We expect that a group of patients with both treatment methods at the same time will offer the best results in terms of improving the symptoms of this type of headache;Timepoint(s) of evaluation of this end point: 1 year	—

Countries

Slovenia

Contacts

Public ContactUNIVERSITY MEDICAL CENTRE

UNIVERSITY MEDICAL CENTRE LJUBLJANA

gp.ukc@kclj.si0038601522 50 50

Outcome results

None listed

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