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

Phase 1

• Conditions: Headache attributed to temporomandibular disorder; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-001912-31-SI
• Lead Sponsor: IVERSITY MEDICAL CENTRE LJUBLJANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-20
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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