Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol

Last updated: May 5, 2026
Sponsor: University of Florida
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Invisalign 3-day wear protocol

Invisalign 7-day wear protocol

Clinical Study ID

NCT05905224
IRB202300981
  • Ages 18-30
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The hypothesis of this project is that replacing the current 7-day wear protocol with a 3-day wear protocol, while integrating less tooth movement per aligner (reduce the amount of activation per aligner) may produce more consistent and continues orthodontic forces, therefore, increase the predictability, accuracy and outcomes achieved for various types of tooth movements and enhance the rate of tooth movement with the Invisalign system

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Physically healthy with no relevant allergies or medical problems

  • Male or female between the age of 18 and 30.

  • Full permanent dentition except for the third molars

  • Class I crowded dentition primarily for the lower anterior teeth (moderate crowding

  • 4-6 mm - according to Little's Irregularity Index)

  • Good oral hygiene and absence of periodontal disease

  • Malocclusion to be treated with Invisalign aligners (SmartTrack)

  • Any ethnic group

Exclusion

Exclusion Criteria:

  • 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)

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Invisalign 3-day wear protocol
Phase:
Study Start date:
October 30, 2023
Estimated Completion Date:
February 28, 2026

Study Description

This randomized clinical trial aims to assess the effectiveness of increasing the frequency of change per aligner, within the standard of care, on the efficacy of achieving better treatment outcomes. We will study the influence of reducing the wear scheduled for Invisalign clear aligners, from 7-day change per aligner to 3-day change per aligner, on the predictability and accuracy of different orthodontic tooth movements by comparing the simulated predicted final outcomes to those achieved at the end of treatment between the two change protocols.

Connect with a study center

  • University of Florida _ Department of Orthodontics

    Gainesville, Florida 32610-0444
    United States

    Site Not Available

  • University of Florida _ Department of Orthodontics

    Gainesville 4156404, Florida 4155751 32610-0444
    United States

    Site Not Available

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