Using clear aligners to treat dental misalignment in patients with Osteogenesis Imperfecta
Use of Clear Aligners for the Treatment of Dental Malocclusion in Individuals With Osteogenesis Imperfecta
This study is testing if clear aligners like Invisalign can safely and effectively fix dental misalignment in young people with Osteogenesis Imperfecta.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 57 (estimated) |
| Ages | 12 Years to 40 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Trial ID | NCT04815564 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of Invisalign clear aligners for treating dental malocclusion in individuals with Osteogenesis Imperfecta (OI). Given the challenges of traditional braces due to dental issues associated with OI, this approach aims to provide a less invasive alternative. Participants will include individuals aged 12 to 40 with mild to moderate malocclusion and no prior orthodontic treatment. The study will take place at three prominent institutions: McGill University, University of California Los Angeles, and the National Institute of Dental and Craniofacial Research.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12 to 40 with a clinical diagnosis of Osteogenesis Imperfecta and intermediate severity malocclusion.
Not a fit: Patients who have previously undergone orthodontic treatment or require surgical intervention for their malocclusion may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective orthodontic treatment option for patients with Osteogenesis Imperfecta.
How similar studies have performed: While the use of clear aligners is well-established in general orthodontics, this specific application for Osteogenesis Imperfecta is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clinical diagnosis of OI. 2. Malocclusion of intermediate severity defined as a PAR score between 15 and 50. 3. Age range 12 to 40 years at the screening visit. 4. Presence of minimum number of intact teeth to proceed with orthodontic treatment. Exclusion Criteria: 1. Prior orthodontic treatment defined as - any history of braces, palatal expansion or Invisalign treatment. 2. Candidates who meet the PAR score but need surgical intervention for correction of malocclusion 3. Presence of impacted or retained teeth. 4. 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. 5. Presence of other dental, oral or systemic conditions that may interfere with orthodontic treatment. Examples are severe gingivitis, active periodontal disease, cancer. 6. Pregnancy - positive during screening visit.
Where this trial is running
Los Angeles, California and 2 other locations
- University of California Los Angeles — Los Angeles, California, United States (Recruiting)
- Nidcr/Nih — Bethesda, Maryland, United States (Recruiting)
- McGill University — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Janice Lee — Nidcr/nih
- Study coordinator: Dianne Nguyen
- Email: diannen@bcm.edu
- Phone: 713.798.6694
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.