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OpenTrials
Completed

NCT Number: NCT04556448

RCT Comparing Invisalign and Traditional Orthodontic Treatment

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

Completed

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Key information

Conditions

Malocclusion, Angle Class II Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas A&M Baylor College of Dentisry

Dallas, Texas, 75246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Anterior or posterior crossbites
  • Anterior or lateral open bites
  • Maxillary overjet exceeding 3mm
  • Impacted tooth

Treatment and study plan

Aligners

Other

Clear aligners

Other names: Invisalign

Clear braces

Other

Clear braces

Primary outcomes

  1. Occlusal changes

    Time frame: up to 6 months

    Differences in occlusion between the two groups

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Sep 21, 2020
Registry last updated
Sep 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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