Assessment of the Efficacy of the Aerodentis System
Condition: Orthodontic Treatment; Tooth Crowding; Orthodontics
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of the Aerodentis System for
      orthodontic tooth movement in an open label, two-arms, non-inferiority clinical study. This
      open-label, two-arm study will follow 45 patients for up to fifteen months. Thirty
      participants will wear the Aerodentis device, and fifteen participants will wear Invisalign,
      a commonly used clear appliance. Patients will be assigned to participate in the treatment
      group using the Aerodentis device at home for 10 hours daily or in the control group using
      clear correctors for the duration of up to 15 months. Outcome assessments will be performed
      every 4 weeks. Assessments will include tooth movement and quality of life assessments.
    

Detailed description: 
      The Aerodentis system is intended for the treatment of tooth malocclusion and is treated by
      applying force, over time, to teeth requiring alignment. Traditionally, the force has been
      created by attaching brackets to the teeth and creating tension through the stretching of
      flexible wire connected between the brackets. Alternatively, aligners are used for the
      treatment of tooth malocclusion. In these devices, a series of mouthpieces are used, where
      the force created by each mouthpiece on the treated teeth is designed to push the teeth in
      small, one step increments, toward the desired result.The Aerodentis system is comprised of a
      plastic mouthpiece containing an inflatable balloon that provides pressure (force) on the
      selected teeth designated to be moved to a final treated state. The inflatable balloon is
      inflated to the desired pressure using an electrical air pump unit that is programmed by the
      dental practitioner using Dror Orthodesign proprietary software; thus creating a course
      treatment specially designed for each patient.

      A participant is required to wear the Aerodentis device or conventional clear correctors.
      Initial photos of participants will be reviewed to establish a pool of eligible potential
      participants. Then participants will be randomly selected for one of the two groups. Those
      wearing the Aerodentis device will be asked to answer a quality of life questionnaire.
      Follow-up assessments will be conducted every 4 weeks for both Aerodentis participants and
      clear corrector participants. During these assessment's we will look at movement of teeth,
      any side effects or discomfort the individual may be facing, patient assessment of whether
      the Aerodentis device is used regularly. Both intraoral and extraoral photos will be taken of
      patients, during certain time points of the study, as requested by PI or sponsor. If a
      participant enters and completes the entire study, then that individual will be in the study
      for up to 15 months.
    

Intervention name(s): Aerodentis system; Invisalign clear aligner system
Intervention type(s): Device; Device
Intervention description(s): The Aerodentis system is intended for the treatment of tooth malocclusion and is treated by applying force, over time, to teeth requiring alignment. It is an individually-fitted, plastic dental mouthpiece that is inserted and worn by the patient according to the dental practitioner's treatment plan. The Aerodentis system is comprised of a plastic mouthpiece containing an inflatable balloon that provides pressure (force) on the selected teeth designated to be moved to a final treated state. The inflatable balloon is inflated to the desired pressure using an electrical air pump unit that is programmed by the dental practitioner using Dror Orthodesign proprietary software; thus creating a course treatment specially designed for each patient.; Clear aligners are used for the treatment of tooth malocclusion. In these devices, a series of mouthpieces are used, where the force created by each mouthpiece on the treated teeth is designed to push the teeth in small, one step increments, toward the desired result.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment