Efficacy of botulinum toxin in treating temporomandibular disorders

Phase 1

Conditions: Patients are diagnosed TMD (temporomandibular disorder) according to DC/TMD international consortium: myalgia, local myalgia, myofascial pain, myofascial pain with referral.
MedDRA version: 20.0Level: HLTClassification code 10028323Term: Muscle painsSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

Registration Number: EUCTR2018-001597-16-FI

Lead Sponsor: Sitnikova Victoria

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

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

-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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;Main Objective: -To evaluate subjective and objective parameters for pain and jaw function during the BTX-A treatment of masticatory muscles<br>-To identify demographic and diagnostic characteristics that would predict the clinical outcome of the therapy. <br>-To determine the efficacy and safety of the treatment

Secondary Outcome Measures