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

University of Florida

Status: Active, not recruiting

Conditions: Orthodontic Tooth Movement

Treatments: Device: Invisalign 7-day wear protocol; Device: Invisalign 3-day wear protocol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05905224

IRB202300981

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Group 1 (Control)

Active Comparator group

Treatment:

Device: Invisalign 7-day wear protocol

Group 2 (Experimental)

Experimental group

Treatment:

Device: Invisalign 3-day wear protocol