RCT Comparing Invisalign and Traditional Orthodontic Treatment

September 18, 2020 updated by: Peter H. Buschang, Texas A&M University

A Randomized Controlled Trial Comparing the Effectiveness of Invisalign and Traditional Orthodontic Treatments

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas A&M Baylor College of Dentisry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aligners
Invisalign treatment
Other: Aligners
Clear aligners
Other Names:
  • Invisalign
Active Comparator: Traditional braces
Clear braces
Other: Clear braces
Clear braces

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occlusal changes
Time Frame: up to 6 months
Differences in occlusion between the two groups
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas A&M University

Investigators

  • Principal Investigator: Peter Buschang, PhD, TAMU Health Science Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 18, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 18, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-21_COD_Ortho1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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