Clear Aligners for the Treatment of Dental Malocclusion in OI

Summary

Misalignment of teeth and jaws (also called malocclusion) is a common life altering problem facing many individuals with Osteogenesis Imperfecta (OI). The presence of Dentinogenesis Imperfecta in teeth of OI individuals makes the use of conventional orthodontics in the form of braces very challenging. Clear aligners are newer form of orthodontic treatment and is less invasive than braces. Therefore, the aim of our study is to evaluate the efficiency and safety of using Invisalign clear aligners for orthodontic treatment in individuals with Osteogenesis Imperfecta. We seek individual with Osteogenesis Imperfecta, with mild to moderate malocclusion and no prior history of orthodontic treatment. This study will be held at three sites - McGill University, University of California Los Angeles and National Institute of Dental and Craniofacial research. This study will for the first time, help define guidelines for safe and efficient orthodontic treatment using clear aligners in individuals with Osteogenesis Imperfecta. If successful, this approach can rapidly be implemented into clinical practice, as the Invisalign system is readily available to orthodontists.

Conditions

• Osteogenesis Imperfecta

Interventions

DEVICE

Invisalign

Invisalign clear aligner system

Sponsors & Collaborators

• University of California, Los Angeles

  collaborator OTHER

• McGill University

  collaborator OTHER

• National Institute of Dental and Craniofacial Research (NIDCR)

  collaborator NIH

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Janice Lee · NIDCR/NIH

• Jean-Marc Retrouvey · Baylor College of Medicine

• Deborah Krakow · University of California, Los Angeles

• Julia Cohen-Levy · McGill University

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-01

Primary Completion

2027-08-31

Completion

2027-12-31

FDA Device

Yes

Countries

• United States
• Canada

Study Locations