RCT Comparing Invisalign and Traditional Orthodontic Treatment

NCT ID: NCT04556448

Last Updated: 2020-09-21

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

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-01

Study Completion Date

2019-03-01

Brief Summary

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Comparison of orthodontic patients treated with aligners and traditional (clear braces)

Detailed Description

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Patients were selected based on being adults and having mild Class I malocclusion. They were randomly allocated into either the aligner group and the traditiona (clear braces group).. The aligner group was treated with invisalign, with up to two adjustments at the end of treatment. The traditional group had clear braces placed on their teeth. The outcome variables including the following: 1) pain and discomfort related to treatment, 2) posttreatment occlusal status, and 3) postretention occlusal status.

Conditions

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Malocclusion, Angle Class II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Aligners

Invisalign treatment

Group Type EXPERIMENTAL

Aligners

Intervention Type OTHER

Clear aligners

Traditional braces

Clear braces

Group Type ACTIVE_COMPARATOR

Clear braces

Intervention Type OTHER

Clear braces

Interventions

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Aligners

Clear aligners

Intervention Type OTHER

Clear braces

Clear braces

Intervention Type OTHER

Other Intervention Names

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Invisalign

Eligibility Criteria

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Inclusion Criteria

1. Class I molar and canine relationships
2. Non-extraction treatments
3. Mandibular crowding of 4 mm or less
4. No missing tooth (from second to second molar)

Exclusion Criteria

1. Anterior or posterior crossbites
2. Anterior or lateral open bites
3. Maxillary overjet exceeding 3mm
4. Impacted tooth
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Texas A&M University

OTHER

Sponsor Role lead

Responsible Party

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Peter H. Buschang

Professor, Orthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Buschang, PhD

Role: PRINCIPAL_INVESTIGATOR

TAMU Health Science Center

Locations

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Texas A&M Baylor College of Dentisry

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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2012-21_COD_Ortho1

Identifier Type: -

Identifier Source: org_study_id

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