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Dental Malocclusion and Craniofacial Development in OI

NCT ID: NCT02934451

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteogenesis Imperfecta

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shriners Hospitals for Children

OTHER

Sponsor Role collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role collaborator

University of Nebraska

OTHER

Sponsor Role collaborator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

OTHER

Sponsor Role collaborator

Children's National Research Institute

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Brendan Lee

Professor and Chairman

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Marc Retrouvey, D.M.D.

Role: STUDY_CHAIR

McGill University

Reid Sutton, M.D.

Role: STUDY_CHAIR

Baylor College of Medicine

Frank Rauch, M.D.

Role: STUDY_CHAIR

Shriners Hospital for Children

Locations

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University of California Los Angeles

Los Angeles, California, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Shriners Hospital for Children

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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7704

Identifier Type: -

Identifier Source: org_study_id