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Clear Aligners for the Treatment of Dental Malocclusion in OI

About

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 teeth of OI individuals makes the use of conventional orthodontics in the form of braces very challenging. Clear aligners are newer form of orthodontic treatment and is less invasive than braces. Therefore, the aim of our study is to evaluate the efficiency and safety of using Invisalign clear aligners for orthodontic treatment in individuals with Osteogenesis Imperfecta. We seek individual with Osteogenesis Imperfecta, with mild to moderate malocclusion and no prior history of orthodontic treatment. This study will be held at three sites - McGill University, University of California Los Angeles and National Institute of Dental and Craniofacial research. This study will for the first time, help define guidelines for safe and efficient orthodontic treatment using clear aligners in individuals with Osteogenesis Imperfecta. If successful, this approach can rapidly be implemented into clinical practice, as the Invisalign system is readily available to orthodontists.

Primary Purpose
Supportive care
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
12 Years
Maximum Age
40 Years

Inclusion Criteria:

  • 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 Criteria:

  • 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.

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Study Stats
Protocol No.
21-001314
Category
Genetic and Rare Diseases
Musculoskeletal Disorders
Contact
SARAH GAUNT
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04815564
For detailed technical eligibility, visit ClinicalTrials.gov.