ACTIVE_NOT_RECRUITING

Clear Aligners for the Treatment of Dental Malocclusion in OI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Use of Clear Aligners for the Treatment of Dental Malocclusion in Individuals With Osteogenesis Imperfecta

Quick Facts

Study Start:2022-08-01

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04815564

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Janice Lee

PRINCIPAL_INVESTIGATOR

NIDCR/NIH

Jean-Marc Retrouvey

PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Deborah Krakow

PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Julia Cohen-Levy

PRINCIPAL_INVESTIGATOR

McGill University

Study Locations (Sites)

University of California Los Angeles

Los Angeles, California, 90095

United States

Nidcr/Nih

Bethesda, Maryland, 20892-1470

United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

Janice Lee, PRINCIPAL_INVESTIGATOR, NIDCR/NIH
Jean-Marc Retrouvey, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine
Deborah Krakow, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles
Julia Cohen-Levy, PRINCIPAL_INVESTIGATOR, McGill University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-01

Study Completion Date2027-12

Study Record Updates

Study Start Date2022-08-01

Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

Osteogenesis Imperfecta