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

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Maxillary Lateral Incisor Malocclusion

Treatments: Device: Horizontal attachment; Device: Optimized attachment; Device: Gingivally-beveled attachment; Device: Incisally-beveled attachment

Study type: Interventional

Funder types: Other

Identifiers

NCT04968353

HM20021396

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 4 patient groups

Incisally-beveled

Active Comparator group

Description:

Use of incisally-beveled attachment to extrude lateral incisor

Treatment:

Device: Incisally-beveled attachment

Gingivally-beveled

Active Comparator group

Description:

Use of gingivally-beveled attachment to extrude lateral incisor

Treatment:

Device: Gingivally-beveled attachment

Optimized

Active Comparator group

Description:

Use of optimized attachment to extrude lateral incisor

Treatment:

Device: Optimized attachment

Horizontal

Active Comparator group

Description:

Use of horizontal (unbeveled) attachment to extrude lateral incisor

Treatment:

Device: Horizontal attachment