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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT06934603
Eligibility Criteria:
Inclusion Criteria:
* Individuals (all sexes, genders, races, and ethnicities) aged at least 10 years (in adult dentition) and at most 75 years
* Receiving comprehensive, Phase II orthodontic treatment with clear aligner therapy
* Stable physical health (ASA I or II), as determined by study coordinator or PI
* Able to comprehend and follow requirements of study (including availability on scheduled visit dates)
* Patient and parental consent (and assent for minors) for participation in the study
Exclusion Criteria:
* Receiving orthodontic treatment with fixed appliances
* Receiving hybrid treatment with fixed appliances and aligners
* Receiving Phase I orthodontic treatment with fixed appliances
* Established history of severe xerostomia (dry mouth), severe periodontal disease with actively bleeding gums, significant oral abrasions/ulcers or growths, current alcohol abuse, and/or recreational drug abuse
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with participation
* Drinking, eating, or brushing teeth within 1 hour of study visit
* Removing aligners within 1 hour of study visit
* Developmental or cognitive disability such that the patient cannot self-consent, comprehend, and follow the requirements of the study based on research site personnel's assessment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
75 Years
Study:
NCT06934603
Study Brief:
Protocol Section:
NCT06934603