Effect of Clear Aligner Attachment Design on Extrusion of Maxillary Lateral Incisors

Study Overview
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Brief Summary
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The purpose of this research is to test which of four clear aligner attachment types is more efficient in extruding (erupting) maxillary lateral incisors vertically into correct position during orthodontic treatment.

Detailed Description
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Attachments are small tooth-colored shapes that are bonded (attached) to teeth before or during treatment with clear aligners. They are like handles, giving aligners something to gently push teeth into correct positions. There are 4 different shapes of attachments that are commonly used to extrude lateral incisors (incisally-beveled, gingivally-beveled, optimized and horizontal). All 4 of these attachments are successful in extruding lateral incisors but there is not enough research evidence to know for sure which attachment would be ideal for a specific circumstance.

Official Title
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Effect of Clear Aligner Attachment Design on Extrusion of Maxillary Lateral Incisors: a Randomized Prospective Clinical Trial

Conditions
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Maxillary Lateral Incisor Malocclusion

Intervention / Treatment
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* Device: Incisally-beveled attachment
* Device: Gingivally-beveled attachment
* Device: Optimized attachment
* Device: Horizontal attachment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 16 years or older to be treated with either Comprehensive Invisalign or Invisalign Teen, Maxillary lateral incisor requiring 0.3 mm or more extrusion (as determined by ClinCheck), Maxillary arch with less than 6 mm of crowding or spacing, All teeth present and fully erupted (excluding third molars). Exclusion Criteria: Presence of anterior crossbite Any missing teeth in the maxillary arch Treatment plan includes surgery or extraction of any maxillary teeth, Maxillary lateral incisors with pathology or large restorations (crowns) Maxillary lateral incisors have a less than 0.3 mm of extrusion prescribed in the Tooth Movement Table on the Invisalign ClinCheck

Ages Eligible for Study
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Minimum Age: 16 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: Incisally-beveled<br>Use of incisally-beveled attachment to extrude lateral incisor | Device: Incisally-beveled attachment<br>* Incisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners<br>|
| Active Comparator: Gingivally-beveled<br>Use of gingivally-beveled attachment to extrude lateral incisor | Device: Gingivally-beveled attachment<br>* Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners<br>|
| Active Comparator: Optimized<br>Use of optimized attachment to extrude lateral incisor | Device: Optimized attachment<br>* Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners<br>|
| Active Comparator: Horizontal<br>Use of horizontal (unbeveled) attachment to extrude lateral incisor | Device: Horizontal attachment<br>* Horizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Vertical Tooth Movement | Percent achieved of the vertical (inciso-gingival) tooth movement will be assessed by comparing the initial ClinCheck software estimate tooth movement required to the amount of tooth movement observed | 6 months |