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NCT04556448 Clinical Trial

RCT Comparing Invisalign and Traditional Orthodontic Treatment

Malocclusion, Angle Class II Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04556448
Other study ID # 2012-21_COD_Ortho1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2013
Est. completion date March 1, 2019

Study information
Verified date September 2020
Source Texas A&M University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date March 1, 2019
Est. primary completion date March 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Aligners
Clear aligners
• Clear braces
Clear braces

Locations
Country Name City State
United States Texas A&M Baylor College of Dentisry Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occlusal changes Differences in occlusion between the two groups up to 6 months
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