Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol on the Predictability of Orthodontic Tooth Movement

Study Overview
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Brief Summary
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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

Official Title
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A Randomized Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol on the Predictability of Orthodontic Tooth Movement

Conditions
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Orthodontic Tooth Movement

Intervention / Treatment
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* Device: Invisalign 7-day wear protocol
* Device: Invisalign 3-day wear protocol


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (Control)<br> | Device: Invisalign 7-day wear protocol<br>* Clear Aligners' (Invisalign, Align technology, San Jose, Calif) 7-day wear protocol<br>|
| Experimental: Group 2 (Experimental)<br> | Device: Invisalign 3-day wear protocol<br>* Clear Aligners' (Invisalign, Align technology, San Jose, Calif) 3-day wear protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | assess the influence of reducing the wear scheduled for Invisalign clear aligners, from 7- day wear to 3-day wear, on the predictability and accuracy of different orthodontic tooth movements by comparing the simulated predicted final outcomes to those achieved at the end of treatment between the two wear protocols. | 14 months | 
| 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 | compare and quantify the magnitude and rate of orthodontic tooth movement between the suggested (3-day) and conventional (7-day) wear protocols for the Invisalign® system using the Dental Monitoring superimposed scans and the data collected from their online platform in the first 8 weeks after Invisalign delivery. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of treatment | the total time needed to complete treatment | 14 months | 
| number of refinements and visits needed for each wear protocol. | the number of additional mid adjustment treatment scans needed for each included subject during the clinical trial duration | 14 months | 
| Occlusal outcomes | The Peer Assessment rate and/or ABO grading system will be used to measure the final occlusal outcomes achieved in both groups for them to be compared. | 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clear aligners, wear protocol, 3-day wear, 7-day wear, rate and amount of tooth movement, accuracy, outcomes