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

NCT ID: NCT04968353

Last Updated: 2023-06-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-06-03

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.

Conditions

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Maxillary Lateral Incisor Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Incisally-beveled

Use of incisally-beveled attachment to extrude lateral incisor

Group Type ACTIVE_COMPARATOR

Incisally-beveled attachment

Intervention Type DEVICE

Incisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners

Gingivally-beveled

Use of gingivally-beveled attachment to extrude lateral incisor

Group Type ACTIVE_COMPARATOR

Gingivally-beveled attachment

Intervention Type DEVICE

Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners

Optimized

Use of optimized attachment to extrude lateral incisor

Group Type ACTIVE_COMPARATOR

Optimized attachment

Intervention Type DEVICE

Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners

Horizontal

Use of horizontal (unbeveled) attachment to extrude lateral incisor

Group Type ACTIVE_COMPARATOR

Horizontal attachment

Intervention Type DEVICE

Horizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners

Interventions

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Incisally-beveled attachment

Incisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners

Intervention Type DEVICE

Gingivally-beveled attachment

Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners

Intervention Type DEVICE

Optimized attachment

Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners

Intervention Type DEVICE

Horizontal attachment

Horizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Lindauer, DDS

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Groody JT, Lindauer SJ, Kravitz ND, Carrico CK, Madurantakam P, Shroff B, Darkazanli M, Gardner WG. Effect of clear aligner attachment design on extrusion of maxillary lateral incisors: A multicenter, single-blind randomized clinical trial. Am J Orthod Dentofacial Orthop. 2023 Nov;164(5):618-627. doi: 10.1016/j.ajodo.2023.07.011. Epub 2023 Aug 21.

Reference Type DERIVED
PMID: 37610383 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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HM20021396

Identifier Type: -

Identifier Source: org_study_id

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