Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol (NCT05905224) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol
United States40 participantsStarted 2023-10-30
Plain-language summary
The hypothesis of this project is that replacing the current 7-day wear protocol with a 3-day wear protocol, while integrating less tooth movement per aligner (reduce the amount of activation per aligner) may produce more consistent and continues orthodontic forces, therefore, increase the predictability, accuracy and outcomes achieved for various types of tooth movements and enhance the rate of tooth movement with the Invisalign system
Who can participate
Age range
18 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Physically healthy with no relevant allergies or medical problems
* Male or female between the age of 18 and 30.
* Full permanent dentition except for the third molars
* Class I crowded dentition primarily for the lower anterior teeth (moderate crowding - 4-6 mm - according to Little's Irregularity Index)
* Good oral hygiene and absence of periodontal disease
* Malocclusion to be treated with Invisalign aligners (SmartTrack)
* Any ethnic group
Exclusion Criteria:
* Orthognathic surgical cases
* An extraction treatment plan
* Poor oral hygiene
* Patients with syndromes or craniofacial anomalies.
* The use of any other orthodontic appliance than clear aligners' (Invisalign)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
predictability of the different orthodontic tooth achieved in each of the studies groups movements achieved at the end of treatment in each of the studied groups (3-day wear vs 7-day wear).
Timeframe: 14 months
2
rate of tooth movement for the lower anterior teeth as detected by the consecutive scans captured by the scan box (Dental Monitoring®) in the first 8 weeks of treatment