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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-30

Study Completion Date

2028-08-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Orthodontic Tooth Movement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1 (Control)

Group Type ACTIVE_COMPARATOR

Invisalign 7-day wear protocol

Intervention Type DEVICE

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

Group 2 (Experimental)

Group Type EXPERIMENTAL

Invisalign 3-day wear protocol

Intervention Type DEVICE

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

Interventions

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Invisalign 7-day wear protocol

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

Intervention Type DEVICE

Invisalign 3-day wear protocol

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

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes