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Clear Aligners for the Treatment of Dental Malocclusion in OI Types III and IV

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ClinicalTrials.gov Identifier: NCT04815564
Recruitment Status : Not yet recruiting
First Posted : March 25, 2021
Last Update Posted : June 8, 2021
Sponsor:
Collaborators:
University of California, Los Angeles
University of Missouri, Kansas City
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Brendan Lee, Baylor College of Medicine

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 Type III or IV, with mild to moderate malocclusion and no prior history of orthodontic treatment. This study will be held at three sites - University of Michigan Kansas City, 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.

Condition or disease Intervention/treatment Phase
Osteogenesis Imperfecta Device: Invisalign Not Applicable

Detailed Description:

Osteogenesis imperfecta (OI) is a heritable connective tissue disorder leading to frequent fractures and bone deformities. In about 90% of individuals with OI, the disease is caused by dominant mutations in one of the two genes coding for collagen type I, COL1A1 and COL1A2. The phenotype of OI ranges widely, which is captured by the Sillence classification of OI into clinical types I through IV. Individuals who have bone disease that is severe enough to lead to long-bone deformities, such as bowing of femurs and tibias, are usually diagnosed with OI type III (severe bone fragility) or IV (moderate bone fragility).

Apart from the well-known features of OI in the extracranial skeleton, OI is frequently associated with dental and craniofacial issues. These abnormalities are a source of major concern to patients. Misalignment of the jaws is a common problem in individuals with OI Type III and IV. Malocclusion associated with OI types III and IV differs markedly from the types of malocclusion commonly observed in the general population. Malocclusion in the general population is predominantly class II, however, OI types III and IV are commonly associated with class III malocclusion. The Invisalign® system (Align Technology, Santa Clara, CA) is a personalized and FDA-approved (Class II device; 510(k) number: K143630) approach to treat malocclusion. It involves incrementally moving teeth with a series of removable, custom-made clear polyurethane trays (aligners) that exert forces on teeth. The aligners are transparent ('clear aligners') and therefore are less visible than traditional braces that are made of metal. An important consideration in the treatment of patients with OI is that Invisalign does not require surface etching and cement bonding of metal braces to the tooth surface, which is difficult in the presence of dentinogenesis imperfecta. In this study, we will therefore use the Invisalign system to treat malocclusion associated with OI. This study will directly inform clinical orthodontic practice in an area of unmet clinical need and utilizes a treatment method that may be immediately implemented.

Individuals who meet the eligibility criteria will be able to enroll in the intervention arm of the study to undergo orthodontic treatment. Participants who fail to meet the eligibility criteria will be offered to participate in the study for observation purposes (natural history arm) without undergoing treatment. Participants in the intervention arm will need to visit the study site every two months for the study duration (28 months). Initial four months will involve observation period followed by two years of orthodontic treatment. Participants in the natural history arm will visit the study site every six months for a period of two years (4 visits). A complete oral exam, craniofacial evaluation, intra-oral photos, intra-oral scans, face photos, masticatory test, cone-beam CT and self-reported questionnaires will be done during the visits.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes Assessor will be blinded to the participant information.
Primary Purpose: Supportive Care
Official Title: Use of Clear Aligners for the Treatment of Dental Malocclusion in Individuals With Osteogenesis Imperfecta Types III and IV
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : July 2026


Arm Intervention/treatment
Experimental: Intervention
Subjects with a PAR score between 15 and 40 and fulfilling the other eligibility criteria will be offered participation in the trial.
Device: Invisalign
Invisalign clear aligner system

No Intervention: Natural History
Subjects with a PAR score outside of 15-40 will be offered the opportunity to remain on study for the Natural History arm.



Primary Outcome Measures :
  1. Change in Peer Assessment Rating score (PAR) [ Time Frame: Day 0, Every two months up to 28 month ]
    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.


Secondary Outcome Measures :
  1. Change in tooth movement [ Time Frame: Every two months from baseline up to 24 months ]
    Change from baseline in anatomical tooth movement at each post-baseline time point


Other Outcome Measures:
  1. QOL [ Time Frame: Day 0 up to 28 months ]
    Change in Oral Health Impact Profile (OHIP-14) from the start of the observation phase to the end of the primary phase of the intervention

  2. Masticatory efficiency [ Time Frame: 2 month and 28 months ]
    Mastication expressed as number of occlusal contacts obtained from the intra-oral scans. A significant increase in the number of occlusal contacts will be interpreted as an improvement in the anatomical aspect of mastication.

  3. Patient Satisfaction [ Time Frame: Day 0 and up to 28months ]
    PSQ is a pool of 41 items assessing satisfaction with various aspects of orthodontic care. These items are paired with five-point Likert scales (1=strongly disagree, 5=strongly agree). A higher score indicates higher satisfaction.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of OI type III or IV.
  2. Malocclusion of intermediate severity defined as a PAR score between 15 and 40.
  3. Age range 12 to 40 years at the screening visit.
  4. Presence of minimum number of intact teeth to proceed with orthodontic treatment.

Exclusion Criteria:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04815564


Contacts
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Contact: Dianne Nguyen 713.798.6694 diannen@bcm.edu

Locations
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United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
United States, Maryland
Nidcr/Nih
Bethesda, Maryland, United States, 20892-1470
Contact: Danielle Elangue    301-451-9733    danielle.elangue@nih.gov   
Principal Investigator: Janice Lee         
United States, Missouri
University of Missouri
Kansas City, Missouri, United States, 64108
Contact: Barbara Adkins    816-235-2156    Adkinsba@umkc.edu   
Principal Investigator: Jean-Marc Retrouvey         
Sponsors and Collaborators
Baylor College of Medicine
University of California, Los Angeles
University of Missouri, Kansas City
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
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Principal Investigator: Janice Lee NIDCR/NIH
Principal Investigator: Jean-Marc Retrouvey University of Missouri, Kansas City
Principal Investigator: Deborah Krakow University of California, Los Angeles
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Responsible Party: Brendan Lee, Professor and Chairman, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04815564    
Other Study ID Numbers: H48518
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Osteogenesis Imperfecta
Malocclusion
Tooth Diseases
Stomatognathic Diseases
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases