RCT Comparing Invisalign and Traditional Orthodontic Trea... | NCT04556448

Studies
RCT Comparing Invisalign and Traditional Orthodontic Treatment

NCT04556448

Sponsor

Texas A&M University

Status

Completed

Last Update Posted

Sep 21, 2020Actual

Enrollment

78Actual

Phase

Not Applicable

Conditions

Malocclusion, Angle Class II

Interventions

Aligners
Clear braces

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2013Actual

Primary Completion Date

Mar 1, 2019Actual

Completion Date

Mar 1, 2019Actual

First Submitted Date

Sep 15, 2020

First Submission Date that Met QC Criteria

Sep 18, 2020

First Posted Date

Sep 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2020

Last Update Posted Date

Sep 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aligners	Experimental	Invisalign treatment	Other: Aligners
Traditional braces	Active Comparator	Clear braces	Other: Clear braces

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aligners	Other	Clear aligners	Aligners	Invisalign

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occlusal changes	Differences in occlusion between the two groups	up to 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Buschang, PhD	TAMU Health Science Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Texas A&M Baylor College of Dentisry		Dallas	Texas	75246	United States

Condition Browse Module

MeSH Terms

ID	Term
D008312	Malocclusion, Angle Class II

Ancestor Terms

ID	Term
D008310	Malocclusion
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009968	Orthodontic Appliances, Removable

Ancestor Terms

ID	Term
D009967	Orthodontic Appliances
D009970	Orthodontics
D003813	Dentistry

Browse Leaves

Not provided

Browse Branches

Not provided