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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT05555628
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of sleep Bruxism according to the criteria of the International Classification of Sleep Disorders (ICSD) of the American Academy of Sleep Medicine (AASM) (5);
2. 18-50 age range
3. The diagnosis of awake bruxism, which was determined by a positive answer to the questions of the questionnaire developed according to Pintado's recommendations (6);
4. Pain around the jaw is 3 or more on the visual analog scale (7)
5. Patients who volunteered to participate in the study
Exclusion Criteria:
1. Systemic and/or degenerative disorders
2. Neurological or psychiatric diseases (excluding anxiety and depression)
3. Use of drugs that affect sleep or motor behavior
4. Arthrogenic or mixed temporomandibular disorder
5. Axis I myogenic TMD according to investigational diagnostic criteria for temporomandibular disorders (RDC/TMD)
6. Patients using total prosthesis
7. Direct trauma or previous surgical intervention in the orofacial region
8. Patients using muscle relaxants and non-steroidal anti-inflammatory drugs.
9. Patients using removable prostheses
10. Patients who have received any treatment for bruxism
11. Patients who did not want to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05555628
Study Brief:
Protocol Section:
NCT05555628