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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 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.

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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.

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

FieldValue
Enrollment Target 57 participants
Start Date 2022-08-01
Est. Completion 2027-12
Phase NA

Sponsor

Baylor College of Medicine

616 total trials

What the Registry Record Tells You About NCT04815564

The ClinicalTrials.gov registry entry for NCT04815564 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 157-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (64% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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