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Completed

NCT Number: NCT05905224

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

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

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Key information

Conditions

Orthodontic Tooth Movement

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida _ Department of Orthodontics

Gainesville, Florida, 32610-0444, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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 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)

Treatment and study plan

Invisalign 7-day wear protocol

Device

Clear Aligners' (Invisalign, Align technology, San Jose, Calif) 7-day wear protocol

Invisalign 3-day wear protocol

Device

Clear Aligners' (Invisalign, Align technology, San Jose, Calif) 3-day wear protocol

Primary outcomes

  1. predictability of the different orthodontic tooth achieved in each of the studies groups movements achieved at the end of treatment in each of the studied groups (3-day wear vs 7-day wear).

    Time frame: 14 months

    assess the influence of reducing the wear scheduled for Invisalign clear aligners, from 7- day wear to 3-day wear, 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 wear protocols.

  2. rate of tooth movement for the lower anterior teeth as detected by the consecutive scans captured by the scan box (Dental Monitoring®) in the first 8 weeks of treatment

    Time frame: 2 months

    compare and quantify the magnitude and rate of orthodontic tooth movement between the suggested (3-day) and conventional (7-day) wear protocols for the Invisalign® system using the Dental Monitoring superimposed scans and the data collected from their online platform in the first 8 weeks after Invisalign delivery.

Secondary outcomes

  1. duration of treatment

    Time frame: 14 months

    the total time needed to complete treatment

  2. number of refinements and visits needed for each wear protocol.

    Time frame: 14 months

    the number of additional mid adjustment treatment scans needed for each included subject during the clinical trial duration

  3. Occlusal outcomes

    Time frame: 14 months

    The Peer Assessment rate and/or ABO grading system will be used to measure the final occlusal outcomes achieved in both groups for them to be compared.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

A Randomized Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol on the Predictability of Orthodontic Tooth Movement

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2023
Registry last updated
May 6, 2026

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.

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