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

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

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

Study Overview

• Status: Recruiting
• Conditions: Orthodontic Tooth Movement
• Intervention / Treatment: Device: Invisalign 7-day wear protocol; Device: Invisalign 3-day wear protocol

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610-0444
      • Recruiting
      • University of Florida _ Department of Orthodontics
      • Contact: Sarah Abu Arqub; Phone Number: 352-273-5700; Email: sabuarqub@ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 (Control)	Device: Invisalign 7-day wear protocol; Clear Aligners' (Invisalign, Align technology, San Jose, Calif) 7-day wear protocol
Experimental: Group 2 (Experimental)	Device: Invisalign 3-day wear protocol; Clear Aligners' (Invisalign, Align technology, San Jose, Calif) 3-day wear protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of treatment	the total time needed to complete treatment	14 months
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
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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Align Technology, Inc.
• Investigators: Principal Investigator: Sarah Abu Arqub, DDS, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: outcomes; accuracy; clear aligners; wear protocol; 3-day wear; 7-day wear; rate and amount of tooth movement
• Other Study ID Numbers: IRB202300981

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes