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

University of Florida40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Orthodontic Tooth Movement

Interventions

Invisalign 7-day wear protocolDEVICE

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

Invisalign 3-day wear protocolDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

University of Florida _ Department of Orthodontics

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 2 months

Secondary Outcomes

duration of treatment

the total time needed to complete treatment

Time frame: 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

Time frame: 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.

Time frame: 14 months

Data from ClinicalTrials.gov

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