Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07460895
Eligibility Criteria:
Inclusion Criteria:
* Individuals with myofascial TMD (ICD-9 729.1; ICD-10 M79.1) diagnosed according to the DC/TMD criteria;
* Participants aged 18 years or older;
* Individuals able to communicate, read, write, and provide written informed consent in Portuguese.
Exclusion Criteria:
* Patients with a history of autoimmune connective tissue diseases, such as rheumatoid arthritis, psoriatic arthritis, scleroderma, or systemic lupus erythematosus;
* History of malignancy in the head and neck region within the past 2 years (except basal cell carcinoma) who have undergone head and neck radiation therapy and/or surgery affecting facial muscles;
* Patients who have undergone temporomandibular joint surgery or orthognathic surgery;
* Pregnant or breastfeeding women;
* Patients with poorly adapted prostheses and/or prostheses associated with inadequate increase or decrease of the vertical dimension;
* Patients with a history of tardive dyskinesia or oromandibular/cervical dystonia; -Patients with maximum mouth opening less than 35 mm;
* Patients using systemic medications with a potential effect on pain at the time of screening will not be included in the study, including analgesics, anti-inflammatory drugs, muscle relaxants, corticosteroids, or other medications with analgesic and/or anti-inflammatory effects.
If a participant initiates the use of any such medication during the follow-up period, the participant will be excluded from the study.
\- Patients receiving oral and/or intravenous corticosteroid bolus therapy at doses \> 1 mg/kg within the past 3 months, and those receiving biologic agents within 1 month or five times the drug half-life, whichever is longer; Individuals with mental or psychological conditions that may prevent participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07460895
Study Brief:
Protocol Section:
NCT07460895