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

NCT05905224 | Completed FDA Device

• 1 other identifier: IRB202300981
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Orthodontic Tooth Movement

Keywords

clear aligners; wear protocol; 3-day wear; 7-day wear; rate and amount of tooth movement; accuracy; outcomes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• duration of treatment

  14 months

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

  14 months

• Occlusal outcomes

  14 months

Study Arms (2)

Group 1 (Control)

ACTIVE COMPARATOR

Device: Invisalign 7-day wear protocol

Group 2 (Experimental)

EXPERIMENTAL

Device: Invisalign 3-day wear protocol

Interventions

Invisalign 7-day wear protocol DEVICE

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

Group 1 (Control)

Invisalign 3-day wear protocol DEVICE

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

Group 2 (Experimental)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida _ Department of Orthodontics

Gainesville, Florida, 32610-0444, United States

Location

MeSH Terms

Interventions

Orthodontic Appliances, Removable

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Sarah Abu Arqub, DDS

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 15, 2023
• Study Start: October 30, 2023
• Primary Completion: January 30, 2026
• Study Completion: February 28, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)