Dental Malocclusion and Craniofacial Development in OI

Osteogenesis Imperfecta Clinical Trial

Official title:

Dental Malocclusion and Craniofacial Development in OI

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02934451
• Other study ID #: 7704
• Status: Active, not recruiting
• Start date: August 2016
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion
• Osteogenesis Imperfecta

Locations

Country	Name	City	State
Canada	Shriners Hospital for Children	Montreal	Quebec
United States	Baylor College of Medicine	Houston	Texas
United States	University of California Los Angeles	Los Angeles	California

Sponsors (8)

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

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Teeth Misalignment	Measure teeth misalignment in individuals with moderate to severe OI using scans of the teeth.	5 years
Secondary	Neck Defects	Determine neck defects in individuals with moderate to severe OI using scans of the neck and jaw.	5 years