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OpenTrials
Completed

NCT Number: NCT04968353

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incisally-beveled attachment

Device

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

Gingivally-beveled attachment

Device

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

Optimized attachment

Device

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

Horizontal attachment

Device

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

Primary outcomes

  1. Percent of Vertical Tooth Movement

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 20, 2021
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.