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Dental Malocclusion and Craniofacial Development in OI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02934451
Recruitment Status : Active, not recruiting
First Posted : October 17, 2016
Last Update Posted : January 24, 2022
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Brendan Lee, Baylor College of Medicine

Study Description
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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
Osteogenesis Imperfecta

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
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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 : August 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Teeth Misalignment [ Time Frame: 5 years ]
    Measure teeth misalignment in individuals with moderate to severe OI using scans of the teeth.


Secondary Outcome Measures :
  1. Neck Defects [ Time Frame: 5 years ]
    Determine neck defects in individuals with moderate to severe OI using scans of the neck and jaw.


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals with Severe OI
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934451


Locations
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United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Canada, Quebec
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
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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
More Information
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Responsible Party: Brendan Lee, Professor and Chairman, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02934451    
Other Study ID Numbers: 7704
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: January 24, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The clinical information collected for this study will be stored in a computer database at the Data Management and Coordinating Center at the University of South Florida in Tampa, FL and also sent to a Federal data repository. A data repository provides a way for researchers to store the information collected during the research study for future research studies. The data management center uses several layers of protection for the clinical data stored in its computer database. It meets all of the local and federal security requirements for research datacenters. Information is stored only using a study identification number. Only the investigators and the study staff who collect and enter study data will have access to the key which links the identification number to the participant.
Additional relevant MeSH terms:
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Osteogenesis Imperfecta
Malocclusion
Tooth Diseases
Stomatognathic Diseases
Osteochondrodysplasias
Bone Diseases, Developmental
 Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases