RCT Comparing Invisalign and Traditional Orthodontic Treatment

Not Applicable

Completed

• Conditions: Malocclusion, Angle Class II
• Interventions: Other: Aligners; Other: Clear braces

• Registration Number: NCT04556448
• Lead Sponsor: Texas A&M University

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.

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-18
• Last Update Submitted: 2020-09-18
• Study First Posted: 2020-09-21
• Last Update Posted: 2020-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aligners	Aligners	Invisalign treatment
Traditional braces	Clear braces	Clear braces

Primary Outcome Measures

Name	Time	Method
Occlusal changes	up to 6 months	Differences in occlusion between the two groups

Trial Locations

Locations (1)

Texas A&M Baylor College of Dentisry; 🇺🇸 Dallas, Texas, United States