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 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT04260633
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects ages 18-65 years of age with complete adult dentition, with Class I malocclusion or mild Class II/III malocclusions who are currently in treatment.
* Subjects who do not have systemic diseases that affect orthodontic tooth movement such as patients who are using hormone replacement medications, bone diseases such as osteoporosis or hyper/hypo-thyroidism
* Periodontal probing depths (PD) \< 4mm, gingival index (GI) ≤1, and plaque index (PI) ≤1
* Patients currently in orthodontic treatment with Invisalign who are currently changing their trays every 7 - 10 days
* Participant must have a smartphone that is capable of downloading and storing the Dental Monitoring application
* Participants must be able to master the use of the Dental Monitoring Application
Exclusion Criteria:
Inclusion:
* Male and female subjects ages 18-65 years of age with complete adult dentition, with Class I malocclusion or mild Class II/III malocclusions who are currently in treatment.
* Subjects who do not have systemic diseases that affect orthodontic tooth movement such as patients who are using hormone replacement medications, bone diseases such as osteoporosis or hyper/hypo-thyroidism
* Periodontal probing depths (PD) \< 4mm, gingival index (GI) ≤1, and plaque index (PI) ≤1
* Patients currently in orthodontic treatment with Invisalign who are currently changing their trays every 7 - 10 days
* Participant must have a smartphone that is capable of downloading and storing the Dental Monitoring application
* Participants must be able to master the use of the Dental Monitoring Application
Exclusion:
* Subjects who have within the last 6 mo taken any antibiotic medications or have had any periodontal treatments
* Subjects who have taken/are taking medications that affect bone remodeling: anti-resorptive medications, medications that may affect hormone levels, thyroid replacement medications, corticosteroids, and daily nonsteroidal anti-inflammatory medications
* Subjects who have had chemotherapy or radiation therapy in the last 6 mo
* Subjects who present with severe class II/III malocclusions
* Subjects who present with class I malocclusions but have severe crowding (\> 7 mm) that requires extraction, \>4 mm positive overjet and \> 2 mm negative overjet, extreme deep bite ( \> 90%), severe open bite (\>2 mm)
* Women who are pregnant
* Patients that smoke
* Patients with active caries
* Patients that require interproximal reduction or attachments in the remaining prescription
* Patients who have temporary anchorage devices in place
* Patients who have vertigo or issues with their temporomandibular joint
* Patients with less than 3 mo. remaining in aligner treatment
* Patients who have documented bruxism
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04260633
Study Brief:
Protocol Section:
NCT04260633