NCT04556448

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

6.2 years

First QC Date

September 15, 2020

Last Update Submit

September 18, 2020

Conditions

Malocclusion, Angle Class II

Outcome Measures

Primary Outcomes (1)

  • Occlusal changes

    Differences in occlusion between the two groups

    up to 6 months

Study Arms (2)

Aligners

EXPERIMENTAL

Invisalign treatment

Other: Aligners

Traditional braces

ACTIVE COMPARATOR

Clear braces

Other: Clear braces

Interventions

AlignersOTHER

Clear aligners

Also known as: Invisalign
Aligners
Clear bracesOTHER

Clear braces

Traditional braces

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Class I molar and canine relationships
  • Non-extraction treatments
  • Mandibular crowding of 4 mm or less
  • No missing tooth (from second to second molar)

You may not qualify if:

  • Anterior or posterior crossbites
  • Anterior or lateral open bites
  • Maxillary overjet exceeding 3mm
  • Impacted tooth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas A&M Baylor College of Dentisry

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Orthodontic Appliances, Removable

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontic AppliancesOrthodonticsDentistry

Study Officials

  • Peter Buschang, PhD

    TAMU Health Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Orthodontics

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 21, 2020

Study Start

January 1, 2013

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

September 21, 2020

Record last verified: 2020-09

Locations

US(1)