Improving Orthodontic Compliance with the Innov8 Retainer: Design, Fabrication, Lab Testing and Pilot Trial

Introduction: Following orthodontic treatment, it is often critical that patients wear a retainer to prevent relapse. Removable retainers are commonly used, which rely on patient compliance, however it is well known that patients are not always compliant which can lead to a poor outcome. Recent technological advances have led to the development of removable retainers that record compliance, but to date none have incorporated Bluetooth technology to wirelessly transmit compliance information. Such technology would allow a clinician to intervene immediately upon non-compliance to prevent relapse. Aim: First to develop and conduct preliminary lab testing of the Innov8 Retainer and to develop the Innov8 software and webpage database. Then conduct a pilot study to test the clinical efficacy and accuracy of the newly developed Bluetooth enabled retainer and iOS mobile application. Methods: Following the development and preliminary testing the pilot study was designed. Five subjects were given an Innov8 Retainer, logbook and iPod Touch with the Innov8 mobile application (T0). Subjects were instructed to wear the retainer for 12 hours per day, record each time the retainer was inserted or removed and trained to sync the device daily to the mobile application. After the five-day study period (T1), statistical analysis was performed. Results: The median difference between the self- and device-reported data was 35 minutes or 5.1% and 13 minutes or 1.9% using the adjusted calculation method. Conclusions: Subjects were able to successfully wear the retainer and use the mobile application. The device showed a clinically acceptable level of accuracy and usability that validates it for further clinical testing