None listed
Conditions
Brief summary
This study is to find if one type of expander (a plate) is better at widening the upper jaw of children aged 10-16. The expander will be placed on their top teeth and will be one of the following: 1) Hyrax Expander: this is the common type of expander which requires a separate key to turn. 2) Hybrid-Hyrax Expander: this is the normal expander but it also includes two pins placed in the top of the upper jaw (palate) 3) Keles Expander: this is a new type of expander which has a built-in key to turn the expander. This new type of expander is not yet approved by Therapeutic Goods Administration. Our hypothesis is that the Keles expander will work as equally as effectively as the Hyrax, whereas the Hybrid-Hyrax will be more effective in expanding the jaw due to the use of the two palatal pins. Patients will be recruited at the Sydney Dental Hospital and will be included if they meet the inclusion criteria of having a narrow jaw and in the correct age range. Exclusion criteria include if patients have had previous orthodontic treatment and/or any serious health issues that may impact orthodontic treatment. 60 selected patients will be randomly placed into 3 groups of 20 patients each. Records of patients will be taken before treatment. The appliance will be constructed and installed on each patient. Patients will be taught to turn the expander and will continue expanding until the correct amount of expansion has been achieved. After this, the expander will be locked to prevent further turning and the patient left with the expander in-situ for 6 months to retain the changes in the expanded jaw. The expander is then removed and then new records taking. Patients are then followed up to continue with normal braces treatment as per normal. The records taken of participants will include: questionaires, photos, study casts, 3d photos, and Cone Beam CT images. The data retrieved from these records will be used to assess the dental, skeletal, facial and airyway changes as a result of the expansion. The primary outcome will be to assess the change in angulation of upper first molars relatve to the palate in cross section on Cone Beam CT images. Secondary outcomes include: easability of the difference appliances, airway changes, facial changes and skeletal changes measured on CT images..
Interventions
All patients recruited to this research will be given one of three different information brochures, (Parents; 10-12 year olds, and 12-16 year olds) with each adjusted to the relavent reading age. Each brochure has information regarding the three different possible interventions; possible side effects; participation requirements and contact information of the researchers. Prior to the intervention, patients will have photos, 3d photographic scans, study casts of their teeth, and cone beam CT taken to record as baseline values. There are three seperate intervention arms: Arm 1: Hyrax expansion group (which will act as control) Arm 2: Hybrid Hyrax expansion group, Arm3: Keles expansion group. These will all be performed at the Sydney Dental Hospital by three different training Orthodontic registrars under the supervision of one professor and two senior lectures who have a minimum of 15 years experience in Orthodontics. Once recruited, each patient is randomized into one of three arms. The key difference in the interventions is described below Arm 1 Hyrax: to use a conventional expansion device which is attached only to the first upper premolars and upper first molars Arm 2 Hybrid Hyrax: to use a conventional expansion device which is attached to the first upper molars but also to two mini implants that are placed in the palate Arm 3 Keles Expansion: A novel expansion device which is similar to the conventional expansion device in action and attached to the upper first premolars and molars, with the only difference being that the device has a built in operating arm, whereas the conventional expansion device requires an external key. In all three groups, the participants will be instructed to turn the expansion device twice a day, resulting in 0.5mm of expansion a day. The use of the device will be demonstrated to the patient and their guardians, as well as an instructional video given for home viewing. Interventional adherence will be monitored by using a calendar and patients reviewed on a weekly basis. They will be continued to be monitored weekly at Sydney Dental hospital until it is determined that an adequate amount of expansion has been achieved and then instructed to stop turning. This will be determined by the orthodontic registar and defined as when there is no longer a posterior crossbite between the upper and lower dentition. The expansion device will then be locked so that no further turning can occur. Patients will then have 6 months of the devices in situ to stabilize the expansion. After 6 months the devices will be removed and new records taken. Fixed orthodontic appliances will then be placed to correct any further orthodontic issues.
Sponsors
Study design
Eligibility
Inclusion criteria
Transverse discrepancy between the maxilla and mandible to be more than 5mm as measured from the upper first molar palatal cusp tips to the lower first molar groove Erupted permanent maxillary first molars and first premolars
Exclusion criteria
o Unerupted permanent maxillary first premolars or first molars o History of previous orthodontic treatment o Women who are pregnant o People with an intellectual or mental impairment o People highly dependent on medical care o History of congenital deformity o Periodontal disease o Surgical treatment that may affect the rapid maxillary expansion outcome