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

Primary Purpose

Maxillary Lateral Incisor Malocclusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incisally-beveled attachment
Gingivally-beveled attachment
Optimized attachment
Horizontal attachment
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maxillary Lateral Incisor Malocclusion

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Incisally-beveled

Gingivally-beveled

Optimized

Horizontal

Arm Description

Use of incisally-beveled attachment to extrude lateral incisor

Use of gingivally-beveled attachment to extrude lateral incisor

Use of optimized attachment to extrude lateral incisor

Use of horizontal (unbeveled) attachment to extrude lateral incisor

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 9, 2021
Last Updated
June 27, 2023
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT04968353
Brief Title
Effect of Clear Aligner Attachment Design on Extrusion of Maxillary Lateral Incisors
Official Title
Effect of Clear Aligner Attachment Design on Extrusion of Maxillary Lateral Incisors: a Randomized Prospective Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
June 3, 2022 (Actual)
Study Completion Date
June 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillary Lateral Incisor Malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Incisally-beveled
Arm Type
Active Comparator
Arm Description
Use of incisally-beveled attachment to extrude lateral incisor
Arm Title
Gingivally-beveled
Arm Type
Active Comparator
Arm Description
Use of gingivally-beveled attachment to extrude lateral incisor
Arm Title
Optimized
Arm Type
Active Comparator
Arm Description
Use of optimized attachment to extrude lateral incisor
Arm Title
Horizontal
Arm Type
Active Comparator
Arm Description
Use of horizontal (unbeveled) attachment to extrude lateral incisor
Intervention Type
Device
Intervention Name(s)
Incisally-beveled attachment
Intervention Description
Incisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
Intervention Type
Device
Intervention Name(s)
Gingivally-beveled attachment
Intervention Description
Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
Intervention Type
Device
Intervention Name(s)
Optimized attachment
Intervention Description
Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
Intervention Type
Device
Intervention Name(s)
Horizontal attachment
Intervention Description
Horizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
Primary Outcome Measure Information:
Title
Percent of Vertical Tooth Movement
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Lindauer, DDS
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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