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

Not Applicable

Active, not recruiting

• Conditions: Orthodontic Tooth Movement
• Interventions: Device: Invisalign 7-day wear protocol; Device: Invisalign 3-day wear protocol

• Registration Number: NCT05905224
• Lead Sponsor: University of Florida

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-15
• Study Start: 2023-10-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (Control)	Invisalign 7-day wear protocol	-
Group 2 (Experimental)	Invisalign 3-day wear protocol	-

Primary Outcome Measures

Name	Time	Method
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	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.
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).	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.

Secondary Outcome Measures

Name	Time	Method
duration of treatment	14 months	the total time needed to complete treatment
Occlusal outcomes	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.
number of refinements and visits needed for each wear protocol.	14 months	the number of additional mid adjustment treatment scans needed for each included subject during the clinical trial duration

Trial Locations

Locations (1)

University of Florida _ Department of Orthodontics; 🇺🇸 Gainesville, Florida, United States