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:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT07294833
Eligibility Criteria:
Inclusion Criteria (bruxism group):
* Aged 18-65 years.
* Diagnosed with sleep or awake bruxism by a dentomaxillofacial radiologist.
* Diagnosis was based on subjective reports and clinical assessment according to the Standardised Tool for the Assessment of Bruxism (STAB) framework.
* Classified as probable bruxism, defined as the presence of:
* Self-reported behaviors (e.g., grinding, clenching, bracing), and
* Clinical signs (e.g., tooth wear, linea alba, masseter hypertrophy).
Inclusion Criteria (healthy controls):
* Aged 18-65 years.
* Recruited through public campus advertisements.
* Matched for age and sex with the bruxism group.
* No history or symptoms of bruxism, confirmed by self-report and clinical examination.
Exclusion Criteria (applied to all participants):
* History of smoking.
* Respiratory conditions affecting pulmonary function (e.g., obstructive sleep apnea, chronic obstructive pulmonary disease, asthma).
* Difficulty understanding or following instructions.
* Presence of any dental or temporomandibular disorder other than bruxism.
* History of masseter botulinum toxin injection or facial/cervical trauma.
* Current use of sedatives, muscle relaxants, or centrally acting medications.
* Active orthodontic treatment.
* History of COVID-19 infection within the last six months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07294833
Study Brief:
Protocol Section:
NCT07294833