Effects of orthodontic treatment of a small lower jaw in adolescents using an Invisible bite advancement device (IBAD) study

The present investigation aims to evaluate the effects of clear appliance Class II corrector and compare it with the most used functional appliances such as the Herbst® appliance and twin block. Group 1 : Invisible bite advancement device (IBAD) (Smartee ™ clear appliance) Group 2 : Twin Block Appliance Group 3 : Herbst appliance Collection of records: the following records will be collected twice (at 2 weeks post-randomization), and at the end of the functional treatment phase (equal to or more than 9 months). a) Intra- and extra-oral photographs b) Dental impressions (moulds) c) CBCT radiograph image d) 3D image face scanning Patient referrals will be accessed via the Patient Demand & Waitlist Unit at Sydney Dental Hospital (SDH). Further, the participants who satisfy the selection criteria will be contacted via letters to discuss potential participation. They will be provided with additional information and their interest in participation confirmed when they attend a research eligibility screening appointment. All the interventions which participants will undergo in the study are the standard of orthodontic treatment care in the Orthodontics Department of The Sydney Dental Hospital, Sydney Local Health District (SLHD), NSW. There are no additional procedures which will be carried out solely for research purposes. Physical examination: All participants will be assessed for Edward H. Angle’s definition for permanent first molar inter-arch relationship, canine relationship, and overjet and overbite. This assessment is a part of routine orthodontic examination carried out for the orthodontic diagnosis, which also aids in treatment planning. 30 minutes is the duration of procedure and will be carried out by participating patient's treating clinician. Clinical photographs: Both intra-oral photographs and extraoral photographs are taken at baseline (before treatment) and repeated at every appointment. This is also a routine record-keeping method that not only allows visualization of treatment planning but also, enables the clinician to monitor subsequent changes after orthodontic therapy. 30 minutes is the duration of procedure and will be carried out by participating patients treating clinician. Dental impressions (moulds) and bite-registration: The procedure involves making upper and lower teeth moulds with alginate impression material and recording of bite with dental wax. This procedure is routinely done for functional appliance fabrication. 30 minutes is the duration of procedure and will be carried out by participating patients treating clinician. 3D image face scanning: A non-invasive three-dimensional image capturing modality (Bellus3D ARC7 system). This procedure is carried out in 3D for facial scanning in orthodontics for diagnosis and treatment planning. 30 minutes is the duration of procedure and will be carried out by participating patients treating clinician. Cone-beam computed tomography (CBCT) radiograph image: A low-dose CBCT image will be taken twice – Image 1 will be captured at pre-treatment stage, and Image 2 will be captured at the end of post-functional phase of orthodontic treatment (at or more than 9 months from pre-treatment stage). A low dose CBCT image scans are performed for orthodontic purposes using a large FoV with reduced parameters (400 µm, 2 to 4 mA and low dose protocols). The parameters mentioned are not only acceptable for visualization of large anatomical structures. (Baumann, Bornstein et al. 2022) but also, are very low in dosage which is comparable to the combined imaging dosage of orthopantomography, lateral cephalogram, and two bite-wing radiographs. Values of 4 mA seem to be a sufficient exposure parameter to depict the most relevant anatomical structures of the jaws with acceptable image quality. (Baumann, Bornstein et al. 2022, Ihlis, Kadesjö et al. 2022, Lynds, Kadesjö et al. 2022). These recommendations are according (Ludlow, Timothy et al. 2015) to the ALARA (as low as reasonably achievable) principle and has been modified to the ALADA or ALADAIP principle, which means ‘as low as diagnostically acceptable being indication-orientated and patient-specific’. (Ludlow, Timothy et al. 2015, Oenning, Jacobs et al. 2018). 30 minutes is the duration of procedure and will be carried out by an Expert Radiographer at the Department of Oral Medicine and Radiology of Sydney Dental Hospital. Patient compliance monitoring: A Microsensor TheraMon® (MC Technology GmbH, Hargelsberg, Austria) (Figure 5) will be used for objective verification of patients’ compliance. The microsensor is widely used; in orthodontics to monitor children’s adherence to orthodontic treatment, in sleep medicine to monitor special dental sleep appliances to treat patients suffering from obstructive sleep apnea, and in ophthalmology to record temperature values with sufficient precision ensuring reliable wear time recording. The microsensor will allow for a reliable assessment of the effectiveness of treatment with removable appliances used in this study, such as twin block and the invisible bite advancement device (IBAD). This procedure is not routinely done, however, literature suggests that a micorsensors, such as, Theramon®, can be used qualitatively assess patient’s compliance while wearing removable appliances and have shown to be reliable predictors of good patient cooperation. It consists of a (a) polyurethane-coated sensors measuring 12x 8x 4.2 mm that read and record temperature every 15 min to an accuracy of 0.1 C; (b) a docking station that reads the data stored in the sensors; and (c) a software that not only enables an analysis, visualization, and interpretation of data, but also, identifies attempts of tampering/cheating by patients. Group 1: Invisible bite advancement device (IBAD) (Smartee ™ clear appliance) The Invisible bite advancement device (IBAD) (Smartee ™ clear appliance) is a functional appliance that is used to push the bottom teeth and jaw forward to align it with the upper jaw. Also, the appliance will simultaneously correct the crowded teeth. The clear appliance will have a series of aligner-trays which the patient needs to change to a new tray every six-weeks. The expected wear duration of the appliance is 22-hours a day. The appliance will be worn after 6 weeks of enrolment for a period of a minimum of 9 months.