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

Orthodontic Tooth Movement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05905224
• Other study ID #: IRB202300981
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: August 2025

Study information

• Verified date: February 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Orthodontic Tooth Movement

Intervention

Device:
• Invisalign 7-day wear protocol
Clear Aligners' (Invisalign, Align technology, San Jose, Calif) 7-day wear protocol
• Invisalign 3-day wear protocol
Clear Aligners' (Invisalign, Align technology, San Jose, Calif) 3-day wear protocol

Locations

Country	Name	City	State
United States	University of Florida _ Department of Orthodontics	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Align Technology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.	14 months
Primary	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	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.	2 months
Secondary	duration of treatment	the total time needed to complete treatment	14 months
Secondary	number of refinements and visits needed for each wear protocol.	the number of additional mid adjustment treatment scans needed for each included subject during the clinical trial duration	14 months
Secondary	Occlusal outcomes	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.	14 months