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Dental Malocclusion and Craniofacial Development in OI

Sponsor
Baylor College of Medicine (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02934451
Collaborator
Shriners Hospitals for Children (Other), Hospital for Special Surgery, New York (Other), University of Nebraska (Other), Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (Other), Children's National Research Institute (Other), University of California, Los Angeles (Other), Oregon Health and Science University (Other)
75
Enrollment
3
Locations
100
Anticipated Duration (Months)
25
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Osteogenesis imperfecta (OI) is a rare inherited disorder that causes bones to break easily. Individuals with osteogenesis imperfecta break bones often and may have other problems, including hearing loss and pain and difficulty getting around. People with moderate to severe OI may also be diagnosed with dentinogenesis imperfecta (DI). DI is characterized by grey or brown teeth that may chip and wear down and break easily. People with DI may also have skull and neck defects. These patients may have severe teeth misalignment resulting in clinically significant chewing problems. Teeth misalignment in OI is very hard to treat because of the quality and quantity of bone. The overall goal of this study is to improve dental health to improve the quality of life of people with OI.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Investigators will look at dental health in people with OI and will describe teeth misalignment and head and neck defects in individuals with moderate to severe Osteogenesis Imperfecta (OI).

    Investigators will look at results from the Longitudinal study of OI to complete the study evaluations. Several x-rays will be performed for this study. Participants will have a 3D scan of the mouth and a Cone Beam CT scan of the jaw at a baseline visit and at 3 years after the baseline visit. These study visits can be at the same time as the Longitudinal Study of OI study visits.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    75 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Dental Malocclusion and Craniofacial Development in OI
    Actual Study Start Date :
    Aug 1, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Teeth Misalignment [5 years]

      Measure teeth misalignment in individuals with moderate to severe OI using scans of the teeth.

    Secondary Outcome Measures

    1. Neck Defects [5 years]

      Determine neck defects in individuals with moderate to severe OI using scans of the neck and jaw.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Males and females with Clinical diagnosis of OI other than OI type I

    • Individuals 10 years or older

    • Participant of the Brittle Bone Disease (BBD) Longitudinal Study (7701)

    Exclusion Criteria:

    • Individuals who cannot be correctly positioned for valid radiographic analysis (e.g., due to severe scoliosis or short neck secondary to basilar invagination)

    • Women who are pregnant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California Los Angeles Los Angeles California United States 90095
    2 Baylor College of Medicine Houston Texas United States 77030
    3 Shriners Hospital for Children Montreal Quebec Canada H3G 1A6

    Sponsors and Collaborators

    • Baylor College of Medicine
    • Shriners Hospitals for Children
    • Hospital for Special Surgery, New York
    • University of Nebraska
    • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
    • Children's National Research Institute
    • University of California, Los Angeles
    • Oregon Health and Science University

    Investigators

    • Study Chair: Jean-Marc Retrouvey, D.M.D., McGill University
    • Study Chair: Reid Sutton, M.D., Baylor College of Medicine
    • Study Chair: Frank Rauch, M.D., Shriners Hospital for Children

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brendan Lee, Professor and Chairman, Baylor College of Medicine
    ClinicalTrials.gov Identifier:
    NCT02934451
    Other Study ID Numbers:
    • 7704
    First Posted:
    Oct 17, 2016
    Last Update Posted:
    Jan 24, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Osteogenesis Imperfecta
    Malocclusion

    Study Results

    No Results Posted as of Jan 24, 2022