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Orthodontic Treatment

Clear Aligners for Misaligned Teeth in Osteogenesis Imperfecta

N/A
Recruiting
Led By Julia Cohen-Levy
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age range 12 to 40 years at the screening visit
Clinical diagnosis of OI type III or IV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 month and 28 months
Awards & highlights

Study Summary

This trial will help define guidelines for safe and efficient orthodontic treatment of malocclusion for people with Osteogenesis Imperfecta, using clear aligners.

Who is the study for?
This trial is for individuals aged 12-40 with Osteogenesis Imperfecta types III or IV and mild to moderate misaligned teeth, who haven't had previous orthodontic treatments like braces. Participants must have enough intact teeth for the treatment and cannot be pregnant or on certain medications affecting bone metabolism.Check my eligibility
What is being tested?
The study tests Invisalign clear aligners' effectiveness and safety in treating dental malocclusion in people with Osteogenesis Imperfecta. It's a less invasive alternative to braces, conducted at McGill University, UCLA, and NIDCR aiming to establish treatment guidelines.See study design
What are the potential side effects?
While not specified here, typical side effects of using Invisalign may include discomfort or pain from tooth movement, irritation inside the mouth from the aligner edges, and temporary changes in speech.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 12 and 40 years old.
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I have been diagnosed with Osteogenesis Imperfecta type III or IV.
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I am between 12 and 40 years old.
Select...
My teeth misalignment is moderately severe.
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I have been diagnosed with Osteogenesis Imperfecta type III or IV.
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I have enough healthy teeth for braces.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 month and 28 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 month and 28 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Peer Assessment Rating score (PAR)
Secondary outcome measures
Change in tooth movement
Other outcome measures
Masticatory efficiency
Patient Satisfaction
QOL

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Subjects with a PAR score between 15 and 50 and fulfilling the other eligibility criteria will be offered participation in the trial.
Group II: Natural HistoryActive Control1 Intervention
Subjects with a PAR score outside of 15-50 will be offered the opportunity to remain on study for the Natural History arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Invisalign
2015
N/A
~580

Find a Location

Who is running the clinical trial?

McGill UniversityOTHER
394 Previous Clinical Trials
998,324 Total Patients Enrolled
University of Missouri, Kansas CityOTHER
68 Previous Clinical Trials
32,547 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
300 Previous Clinical Trials
848,555 Total Patients Enrolled

Media Library

Invisalign (Orthodontic Treatment) Clinical Trial Eligibility Overview. Trial Name: NCT04815564 — N/A
Invisalign (Orthodontic Treatment) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04815564 — N/A
Osteogenesis Imperfecta Research Study Groups: Intervention, Natural History
Osteogenesis Imperfecta Clinical Trial 2023: Invisalign Highlights & Side Effects. Trial Name: NCT04815564 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are persons aged 25 and above eligible to participate in this trial?

"This clinical trial is searching for participants that are between the ages of 12 and 40."

Answered by AI

What is the current capacity of this research program?

"Affirmative. Clinicaltrials.gov hosts information which confirms that this research is currently calling for participants, with the initial post being made on August 1st 2022 and edited most recently September 19th of the same year. The study necessitates 57 subjects to be found from 3 distinct healthcare facilities."

Answered by AI

Is it possible to participate in this research study?

"This investigation seeks to enrol 57 individuals diagnosed with Lobstein's Disease, aged 12 - 40 years old. Meeting the following criteria is a prerequisite: malocclusion of intermediate intensity (PAR score between 15-40), age range specified above and minimum number of teeth needed for orthodontic therapy."

Answered by AI

Does the protocol for this experiment currently allow intakes?

"Affirmative. Clinicaltrials.gov data indicates that the recruitment of participants for this medical experiment, which was first announced on August 1st 2022, is still underway. The trial seeks 57 patients from 3 distinct facilities."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Nidcr/Nih
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Clear Aligners for the Treatment of Dental Malocclusion in OI
Brendan Lee 2022. "Clear Aligners for the Treatment of Dental Malocclusion in OI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04815564.
All > Osteogenesis Imperfecta
~25 spots leftby Oct 2025
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