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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT03833505
Eligibility Criteria:
Inclusion Criteria:
* Teeth-grinding at least once a week in the last 3 months before recruitment according to the criteria established by the American Academy of Sleep Medicine (AASM)
* Angle class I occlusion
* Mesial step occlusion according to flush terminal plane.
Exclusion Criteria:
* Treated with anti-helminthic drugs in the last 2 months before recruitment
* Drugs used that could affect the central nervous system and prevent sleep (sedatives, anti-depressants, neuroleptics, anti-muscarinics, selective serotonin re-uptake inhibitors)
* Sleep disorders (snoring, insomnia, obstructive sleep apnoea, restless leg syndrome, sleep-related epilepsy)
* Psychiatric or neurological disorders
* Upper respiratory system obstruction (last 15 days),
* Any systemic disease;
* Teeth erosion due to internal (reflux) or external (acidic drinks) factors
* Dermatological problems, associated with the use of BiteStrip (Up2dent, Inc., Pulheim, Germany);
* Unsuitable skin structure;
* Previously diagnosed and treated for bruxism;
* Angle class II or class III occlusion
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
10 Years
Study:
NCT03833505
Study Brief:
Protocol Section:
NCT03833505