Clear Aligners for the Treatment of Dental Malocclusion in OI Types III and IV
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|ClinicalTrials.gov Identifier: NCT04815564|
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : September 21, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Osteogenesis Imperfecta||Device: Invisalign||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||57 participants|
|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|
|Actual Study Start Date :||August 1, 2022|
|Estimated Primary Completion Date :||October 2025|
|Estimated Study Completion Date :||July 2026|
Subjects with a PAR score between 15 and 40 and fulfilling the other eligibility criteria will be offered participation in the trial.
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.
- 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.
- 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
- 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
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||12 Years to 40 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Clinical diagnosis of OI type III or IV.
- Malocclusion of intermediate severity defined as a PAR score between 15 and 40.
- Age range 12 to 40 years at the screening visit.
- Presence of minimum number of intact teeth to proceed with orthodontic treatment.
- 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.
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
|Contact: Dianne Nguyenemail@example.com|
|United States, California|
|University of California Los Angeles||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Hannah Ebbers 310-794-6420 HEbbers@mednet.ucla.edu|
|Principal Investigator: Deborah Krakow, M.D.|
|United States, Maryland|
|Bethesda, Maryland, United States, 20892-1470|
|Contact: Danielle Elangue 301-451-9733 firstname.lastname@example.org|
|Principal Investigator: Janice Lee|
|United States, Missouri|
|University of Missouri||Recruiting|
|Kansas City, Missouri, United States, 64108|
|Contact: Barbara Adkins 816-235-2156 Adkinsba@umkc.edu|
|Principal Investigator: Jean-Marc Retrouvey|
|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|
|Responsible Party:||Brendan Lee, Professor and Chairman, Baylor College of Medicine|
|Other Study ID Numbers:||
|First Posted:||March 25, 2021 Key Record Dates|
|Last Update Posted:||September 21, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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|
Bone Diseases, Developmental
Genetic Diseases, Inborn
Connective Tissue Diseases