Status:
ACTIVE_NOT_RECRUITING
Clear Aligners for the Treatment of Dental Malocclusion in OI
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
University of California, Los Angeles
McGill University
Conditions:
Osteogenesis Imperfecta
Eligibility:
All Genders
12-40 years
Phase:
NA
Brief 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 teet...
Detailed Description
Osteogenesis imperfecta (OI) is a heritable connective tissue disorder leading to frequent fractures and bone deformities. In about 90% of individuals with OI, the disease is caused by dominant mutati...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Prior orthodontic treatment defined as - any history of braces, palatal expansion or Invisalign treatment.
- Candidates who meet the PAR score but need surgical intervention for correction of malocclusion
- Presence of impacted or retained teeth.
- Use of medication, other than bisphosphonates, known to affect bone metabolism and contraindicated on orthodontic treatment, examples are, growth hormone, corticosteroids (chronic use) and thyroid hormones.
- Presence of other dental, oral or systemic conditions that may interfere with orthodontic treatment. Examples are severe gingivitis, active periodontal disease, cancer.
- Pregnancy - positive during screening visit.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04815564
Start Date
August 1 2022
End Date
December 1 2027
Last Update
December 3 2025
Active Locations (3)
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1
University of California Los Angeles
Los Angeles, California, United States, 90095
2
Nidcr/Nih
Bethesda, Maryland, United States, 20892-1470
3
McGill University
Montreal, Quebec, Canada, H3A 1G1