An investigation of treating patients with conventional and skeletal anchored protraction headgear

INTERVENTION: Patients will be recruited from the Orthodontic Department in the Department of Dental Surgery at Mater Dei Hospital, Malta. Subsequently, each name will have a correspondent code for the purpose of anonymization. The design will follow CONSORT guidelines ensuring that a systematic methodology is followed. Routine orthodontic treatment protocols will be followed thus, patients’ pre‐treatment and post‐treatment ‘’Lateral Cephalogram’’ radiographs will be evaluated to assess the skeletal and dental effects of the appliances via assessing specific landmarks. Following the cessation of the treatment, a period of 2 years follow up will assess the stability of facemask therapy prior to the commence of fixed orthodontic appliance treatment. The lateral cephalogram will be analysed using specific angular and linear measurements. Lateral cephalograms will be traced by the same investigator to avoid inter‐examiner error, the same lateral cephalograms will be traced again to establish intra‐examiner reliability. Furthermore, the inter‐examiner reliability test will be conducted to reduce any possible biases. Lateral cephalograms will be analysed by McNamara analysis to assess the angular and linear changes. The same lateral cephalogram images will be used to assess patients’ skeletal maturity using the CVM staging method. In addition, growth charts to assess the change in patients’ height velocity will also be used. Using two indices to assess the patients’ physical maturity will enhance the reliability of all patients being in the pre‐pubertal stages. All patients should be in CS1 and CS2 when facemask treatment will take place. Patients in the hybrid HYRAX facemask group will h CONDITION: Class III malocclusion ; Musculoskeletal Diseases PRIMARY OUTCOME: Compliance rate of wearing protraction headgear assessed using a compliance sensor (Theramon) concealed in the facemask pad over a period of 9 months: T1= 1 month, T2=2 months, T3, T4, T5, T6, T7, T8, and T9. SECONDARY OUTCOME: ; 1. Skeletal and dental‐related outcome measured with a cephalometric x‐ray at T0 before treatment and T1 after treatment; 2. Quality of life assessed using the Child Perception Questionnaire (CPQ8‐11) before study start T0 (baseline) then on monthly for 9 months (T1 to T9); INCLUSION CRITERIA: 1. Skeletal Class III 2. Healthy children with no systemic diseases 3. Age between 8‐12 years 4. Co‐operative children 5. Good oral hygiene 6. True skeletal III without shift 7. All dentition present 8. Healthy periodontium 9. No previous orthodontic treatment