Clear Aligners for the Treatment of Dental Malocclusion in OI

Launched by BAYLOR COLLEGE OF MEDICINE · Mar 22, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the use of clear aligners, specifically the Invisalign system, to treat dental misalignment (called malocclusion) in individuals with Osteogenesis Imperfecta (OI). OI is a condition that affects bone strength and can also make traditional braces difficult to use due to the unique dental challenges that arise, such as Dentinogenesis Imperfecta, which affects the teeth. The goal of this study is to see if clear aligners can be a safe and effective alternative for people with mild to moderate malocclusion who have not had any previous orthodontic treatment. The trial is taking place at three different locations: McGill University, UCLA, and the National Institute of Dental and Craniofacial Research.

To participate in this study, individuals must be between the ages of 12 and 40, have a clinical diagnosis of Osteogenesis Imperfecta, and have a certain level of tooth misalignment, measured by a scoring system. Participants will need to have enough healthy teeth to begin treatment but should not have undergone any prior orthodontic procedures or require surgery for their condition. Throughout the trial, participants will receive clear aligners to help improve their dental alignment, and the results will help establish guidelines for future treatments in those with OI. If this study shows positive outcomes, clear aligners could become a widely accessible option for orthodontic care in individuals with Osteogenesis Imperfecta.

Gender

ALL

Eligibility 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.