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

Study Summary


Osteogenesis imperfecta (OI) can affect the shape of the face, mouth and overall quality of life. There is very little information on the appropriate treatment for teeth misalignment in OI. Most people with severe OI have teeth that crack or chip easily (known as dentinogenesis imperfecta). Due to this, standard dental braces are not an option, as they must be glued onto and then popped off teeth with pliers.

In severe forms of OI there can be significant misalignment of the teeth. Misalignment of teeth may interfere with the following:

  • Gum health
  • Ability to open the jaw
  • Ability to chew effectively
  • Ability to breathe
  • Speech

The purpose of this study is to determine if an orthodontic treatment, using Invisalign® clear aligners, is safe and effective in correcting the misalignment of teeth in individuals with OI.

The study will be about 2 years in duration.

Individuals with OI who are eligible and agree to participate in the study will have the following procedures:

  • Regular visits with an orthodontist to fit aligners and monitor the progress of treatment
  • Photography and x-rays to document any changes in dental alignment
  • Surveys to assess oral health and quality of life

This study is funded by a grant from the National Institutes of Health (NIH) to the Brittle Bone Disease Consortium of the Rare Disease Clinical Research Network. The Brittle Bone Disease Consortium (1U54AR068069-0) is a part of the National Center for Advancing Translational Sciences (NCATS) Rare Diseases Clinical Research Network (RDCRN), and is funded through a collaboration between the Office of Rare Diseases Research (ORDR), NCATS, the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Dental and Craniofacial Research (NIDCR), and the Eunice Kennedy Shriver National Institutes of Child Health and Development (NICHD).  The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Please Note: The Rare Diseases Clinical Research Network will make every effort to enroll all the patients we can, but we cannot make any guarantees that we will be able to enroll everyone in a particular study who wants to participate.