Clear Aligners for the Treatment of Dental Malocclusion in OI

NCT04815564 | Active Not Recruiting DMC FDA Device

• 1 other identifier: H48518
• Study Type: interventional
• Target: 57
• Locations: 2 countries
• Sites: 3

Brief 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

Osteogenesis Imperfecta

Outcome Measures

Primary Outcomes (1)

• Change in Peer Assessment Rating score (PAR)

  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.

  Day 0, Every two months up to 28 month

Secondary Outcomes (1)

• Change in tooth movement

  Every two months from baseline up to 24 months

Other Outcomes (3)

• QOL

  Day 0 up to 28 months

• Masticatory efficiency

  2 month and 28 months

• Patient Satisfaction

  Day 0 and up to 28months

Study Arms (2)

Intervention

EXPERIMENTAL

Subjects with a PAR score between 15 and 50 and fulfilling the other eligibility criteria will be offered participation in the trial.

Device: Invisalign

Natural History

NO INTERVENTION

Subjects with a PAR score outside of 15-50 will be offered the opportunity to remain on study for the Natural History arm.

Interventions

Invisalign DEVICE

Invisalign clear aligner system

Intervention

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical diagnosis of OI.
• Malocclusion of intermediate severity defined as a PAR score between 15 and 50.
• Age range 12 to 40 years at the screening visit.
• Presence of minimum number of intact teeth to proceed with orthodontic treatment.

You may not qualify if:

• Prior orthodontic treatment defined as - any history of braces, palatal expansion or Invisalign treatment.
• Candidates who meet the PAR score but need surgical intervention for correction of malocclusion
• Presence of impacted or retained teeth.
• 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.
• Presence of other dental, oral or systemic conditions that may interfere with orthodontic treatment. Examples are severe gingivitis, active periodontal disease, cancer.
• Pregnancy - positive during screening visit.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• University of California, Los Angeles: collaborator
• McGill University: collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (3)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Nidcr/Nih

Bethesda, Maryland, 20892-1470, United States

Location

McGill University

Montreal, Quebec, H3A 1G1, Canada

Location

MeSH Terms

Conditions

Osteogenesis Imperfecta

Interventions

Orthodontic Appliances, Removable

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Janice Lee

  NIDCR/NIH

  PRINCIPAL INVESTIGATOR

• Jean-Marc Retrouvey

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Deborah Krakow

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Julia Cohen-Levy

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor will be blinded to the participant information.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 25, 2021
• Study Start: August 1, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (2)