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NCT04815564 · ClinicalTrials.gov registry record · NA
Clear Aligners for the Treatment of Dental Malocclusion in OI
A NA study of Osteogenesis Imperfecta, sponsored by Baylor College of Medicine.
- Active
- Registry status
- NA
- Development phase
- 57
- Enrollment target
- 3
- Study locations
NCT04815564: Active NA study of Osteogenesis Imperfecta, sponsored by Baylor College of Medicine.
NCT04815564 is a NA study of Osteogenesis Imperfecta that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 57 participants, below the 157-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (64% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04815564, a NA study of Osteogenesis Imperfecta, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
- 3
- Study locations
Study 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 Outcome
The Peer Assessment Rating (PAR) index is a valid and reliable measure of orthodontic treatment outcome and is the most widely accepted such index. A score of zero represents an ideal occlusion and in general the higher the score, the more extensive the malocclusion.
Conditions Studied
Interventions
- DEVICE Invisalign
Study Locations (3)
California
- University of California Los Angeles - Los Angeles
Maryland
- Nidcr/Nih - Bethesda
Quebec
- McGill University - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2027-12 |
| Phase | NA |
What the registry record for NCT04815564 still lists
NCT04815564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 157-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Osteogenesis Imperfecta appearing as the primary indexed condition, and to 1 intervention - of which Invisalign is the first listed.
NCT04815564 reports a single indexed study location in California, Maryland, Quebec.
Frequently Asked Questions
What is clinical trial NCT04815564 about?
NCT04815564 is a clinical study titled "Clear Aligners for the Treatment of Dental Malocclusion in OI". 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 challengin...
What is the current status of trial NCT04815564?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 57 participants. The study started on 2022-08-01. Estimated completion is 2027-12.
What conditions does trial NCT04815564 study?
This clinical trial studies the following conditions: Osteogenesis Imperfecta.
What interventions are being tested in trial NCT04815564?
The interventions under investigation include: Invisalign (DEVICE).
Who is sponsoring clinical trial NCT04815564?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04815564 being conducted?
This trial has 3 study locations across California, Maryland, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteogenesis Imperfecta
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04815564's enrollment target sits among peer trials
57 10th of 13 higher than 4 of 13 other Osteogenesis Imperfecta trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteogenesis Imperfecta trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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