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Clear Aligners for Misaligned Teeth in Osteogenesis Imperfecta
Study Summary
This trial will help define guidelines for safe and efficient orthodontic treatment of malocclusion for people with Osteogenesis Imperfecta, using clear aligners.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am between 12 and 40 years old.I have been diagnosed with Osteogenesis Imperfecta type III or IV.I do not have severe gum disease, active periodontal disease, or cancer that could affect orthodontic treatment.I am between 12 and 40 years old.My teeth misalignment is moderately severe.I have been diagnosed with Osteogenesis Imperfecta type III or IV.I have teeth that haven't come in or are stuck.I have enough healthy teeth for braces.I am not on medication affecting bone metabolism, except for bisphosphonates.I have enough healthy teeth for braces.I have had braces, palatal expansion, or Invisalign in the past.I need surgery to correct my bite despite meeting the PAR score.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
- Group 1: Intervention
- Group 2: Natural History
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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