NCT06418984

Brief Summary

This randomized clinical trial aims to assess the effectiveness of optimized attachments, IPR and a combination of the two techniques on the rotational accuracy of canines with clear aligners

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2025

Completed
Last Updated

February 6, 2026

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

May 8, 2024

Last Update Submit

February 4, 2026

Conditions

Rotation of Tooth

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Canine rotation

    3D model superimposition will be used to assess the accuracy of tooth movement

    6-9 months

Study Arms (4)

Control

NO INTERVENTION

No Interproximal reduction or attachments will be used to help correct the rotation

Inter proximal reduction

EXPERIMENTAL

Interproximal reduction will be performed in this arm

Device: auxiliary

Optimized attachments

EXPERIMENTAL

optimized composite attachments will be added to this arm

Device: auxiliary

IPR and optimized attachments

EXPERIMENTAL

Both Interproximal reduction will be implemented and optimized attachments will be added to this arm

Device: auxiliary

Interventions

auxiliaryDEVICE

the interventions are related to the adjuncts associated with clear aligners to improve the predictability and accuracy of tooth movement

IPR and optimized attachmentsInter proximal reductionOptimized attachments

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physically healthy with no relevant allergies or medical problems
  • Male or female above 18 years old
  • Full permanent dentition except for the third molars
  • Any type of malocclusion with rotated canines that require derotation
  • Good oral hygiene and absence of periodontal disease
  • Malocclusion to be treated with Invisalign aligners (SmartTrack)
  • Any ethnic group

You may not qualify if:

  • Orthognathic surgical cases
  • An extraction treatment plan
  • Poor oral hygiene
  • Patients with syndromes or craniofacial anomalies.
  • The use of any other orthodontic appliance than clear aligners' (Invisalign)
  • Malocclusion that requires auxiliaries in the simulated plan ( buttons and elastics on the canines)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: one control group and 3 experimental groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 17, 2024

Study Start

October 1, 2024

Primary Completion

December 15, 2025

Study Completion

December 28, 2025

Last Updated

February 6, 2026

Record last verified: 2025-03

Locations

US(1)