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

Not Applicable

Completed

• Conditions: Maxillary Lateral Incisor Malocclusion
• Interventions: Device: Horizontal attachment; Device: Optimized attachment; Device: Incisally-beveled attachment; Device: Gingivally-beveled attachment

• Registration Number: NCT04968353
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-20
• Study Start: 2021-08-01
• Primary Completion: 2022-06-03
• Study Completion: 2022-06-03
• Status Verified: 2023-06
• Results First Submitted: 2023-06-02
• Results First Submitted QC: 2023-06-27
• Last Update Submitted: 2023-06-27
• Results First Posted: 2023-06-28
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients 16 years or older to be treated with either Comprehensive Invisalign or Invisalign Teen,
2. Maxillary lateral incisor requiring 0.3 mm or more extrusion (as determined by ClinCheck),
3. Maxillary arch with less than 6 mm of crowding or spacing,
4. All teeth present and fully erupted (excluding third molars).

Exclusion Criteria

1. Presence of anterior crossbite
2. Any missing teeth in the maxillary arch
3. Treatment plan includes surgery or extraction of any maxillary teeth,
4. Maxillary lateral incisors with pathology or large restorations (crowns)
5. Maxillary lateral incisors have a less than 0.3 mm of extrusion prescribed in the Tooth Movement Table on the Invisalign ClinCheck

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Horizontal	Horizontal attachment	Use of horizontal (unbeveled) attachment to extrude lateral incisor
Optimized	Optimized attachment	Use of optimized attachment to extrude lateral incisor
Incisally-beveled	Incisally-beveled attachment	Use of incisally-beveled attachment to extrude lateral incisor
Gingivally-beveled	Gingivally-beveled attachment	Use of gingivally-beveled attachment to extrude lateral incisor

Primary Outcome Measures

Name	Time	Method
Percent of Vertical Tooth Movement	6 months	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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States