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:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT03606551
Eligibility Criteria:
Inclusion Criteria:
1. Able to understand and willing to voluntarily sign the consent/assent form(s);
2. Willing and able to return to the study facility for scheduled visits and recalls;
3. Have permanent dentition including first molars, premolars, canines, and incisors erupted;
4. Teeth have sound, non-carious buccal enamel, free from white-spot lesions; and,
5. Have good oral hygiene as determined by the orthodontist/dental hygienist.
For intercept patients only:
6. Currently have brackets on their teeth; and,
7. Have begun treatment with rectangular archwires; or, who are in their finishing stage of orthodontic treatment (i.e. they have 3 to 4 months of treatment remaining).
Exclusion Criteria:
1. Currently participating in another clinical study.
2. Difficulty being compliant with study visits, such as those planning or having extensive travel commitments or who lack transportation.
3. Have mental, emotional, or developmental disabilities.
4. Have a complex/surgical case.
5. Have a deep overbite that would result in their maxillary incisor teeth occluding with the ceramic brackets on the mandibular teeth that cannot be avoided.
6. Need essential dental care, i.e., for broken teeth, grossly carious or abscessed teeth.
7. Have dental prostheses/implants that will interfere with projected teeth movement.
8. Have known allergies to product ingredients (e.g. methacrylate resin materials, nickel, chromium).
9. Have a medical or oral condition that, in the investigator's judgement, may compromise the subject's safety or interfere with the conduct and outcome of the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
11 Years
Study:
NCT03606551
Study Brief:
Protocol Section:
NCT03606551