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RCT Comparing Invisalign and Traditional Orthodontic Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04556448
Recruitment Status : Completed
First Posted : September 21, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Peter H. Buschang, Texas A&M University

Study Description
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Brief Summary:
Comparison of orthodontic patients treated with aligners and traditional (clear braces)

Condition or disease Intervention/treatment Phase
Malocclusion, Angle Class II Other: Aligners Other: Clear braces Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized RCT
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing the Effectiveness of Invisalign and Traditional Orthodontic Treatments
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Aligners
Invisalign treatment
 Other: Aligners
Clear aligners
Other Name: Invisalign
Active Comparator: Traditional braces
Clear braces
 Other: Clear braces
Clear braces


Outcome Measures
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Primary Outcome Measures :
  1. Occlusal changes [ Time Frame: up to 6 months ]
    Differences in occlusion between the two groups


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556448


Locations
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United States, Texas
Texas A&M Baylor College of Dentisry
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Texas A&M University
Investigators
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Principal Investigator: Peter Buschang, PhD TAMU Health Science Center
More Information
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Responsible Party: Peter H. Buschang, Professor, Orthodontics, Texas A&M University
ClinicalTrials.gov Identifier: NCT04556448    
Other Study ID Numbers: 2012-21_COD_Ortho1
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malocclusion
Malocclusion, Angle Class II
Overbite
Tooth Diseases
Stomatognathic Diseases