Use of Clear Aligners for the Treatment of Dental Malocclusion in Individuals With Osteogenesis Imperfecta

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 40
Healthy Volunteers: f
View:

• Clinical diagnosis of OI.

• Malocclusion of intermediate severity defined as a PAR score between 15 and 50.

• Age range 12 to 40 years at the screening visit.

• Presence of minimum number of intact teeth to proceed with orthodontic treatment.

Locations
United States
California
University of California Los Angeles
RECRUITING
Los Angeles
Maryland
Nidcr/Nih
RECRUITING
Bethesda
Other Locations
Canada
McGill University
RECRUITING
Montreal
Contact Information
Primary
Dianne Nguyen
diannen@bcm.edu
713.798.6694
Time Frame
Start Date: 2022-08-01
Estimated Completion Date: 2026-07
Participants
Target number of participants: 57
Treatments
Experimental: Intervention
Subjects with a PAR score between 15 and 50 and fulfilling the other eligibility criteria will be offered participation in the trial.
No_intervention: Natural History
Subjects with a PAR score outside of 15-50 will be offered the opportunity to remain on study for the Natural History arm.
Authors
Sponsors
Collaborators: McGill University, National Institute of Dental and Craniofacial Research (NIDCR), University of California, Los Angeles
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov

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