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RCT Comparing Invisalign and Traditional Orthodontic Treatment

Primary Purpose

Malocclusion, Angle Class II

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aligners
Clear braces
Sponsored by
Texas A&M University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class II

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Texas A&M Baylor College of Dentisry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aligners

Traditional braces

Arm Description

Invisalign treatment

Clear braces

Outcomes

Primary Outcome Measures

Occlusal changes
Differences in occlusion between the two groups

Secondary Outcome Measures

Full Information

First Posted
September 15, 2020
Last Updated
September 18, 2020
Sponsor
Texas A&M University
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1. Study Identification

Unique Protocol Identification Number
NCT04556448
Brief Title
RCT Comparing Invisalign and Traditional Orthodontic Treatment
Official Title
A Randomized Controlled Trial Comparing the Effectiveness of Invisalign and Traditional Orthodontic Treatments
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas A&M University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class II

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized RCT
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aligners
Arm Type
Experimental
Arm Description
Invisalign treatment
Arm Title
Traditional braces
Arm Type
Active Comparator
Arm Description
Clear braces
Intervention Type
Other
Intervention Name(s)
Aligners
Other Intervention Name(s)
Invisalign
Intervention Description
Clear aligners
Intervention Type
Other
Intervention Name(s)
Clear braces
Intervention Description
Clear braces
Primary Outcome Measure Information:
Title
Occlusal changes
Description
Differences in occlusion between the two groups
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Buschang, PhD
Organizational Affiliation
TAMU Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas A&M Baylor College of Dentisry
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Learn more about this trial

RCT Comparing Invisalign and Traditional Orthodontic Treatment

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