Malocclusion, Angle Class II
Conditions
Interventions
oral health literacy of the caregivers
cooperation and satisfaction with the treatment
This is a parallel, multicenter, randomized clinical trial involving 60 participants prospectively recruited from two research centers. Blinding of the patient and the operator will not be possible in
and Orthodontic Aligners with Intrabucal Distalizers (OAID) (n = 30) associated with Iceram Clear Intrabucal Distalizers, Orthometric, Marília, Brazil. Patients will be evaluated before (baseline), th
sleep and awake bruxism behavior
attachment detachments, and other complications. All patients included in the sample will undergo orthodontic documentation, including intra and extraoral photographs
cone beam computed tomography (baseline, 12 months, end of treatment, and 1 year post-treatment)
and intraoral digital scanning (baseline, 3, 6, 9, and 12 months, end of treatment, 1 year post-treatment). Throughout the treatment, par
E04.545.500
Sponsors
Universidade Anhaguera - UNIDERP
Universidade Positivo
Align Technology, Inc
Indústria e Comércio de Produtos Médicos e Odontológicos Ltda - Orthometric
Eligibility
Age
10 Years to 14 Years
Inclusion criteria
Inclusion criteria: Age between 10 and 14 years; both sexes; at least half Class II of Angle; convex facial profile, characterizing mandibular retrognathism; pronounced horizontal overjet, greater than 4 mm
Exclusion criteria
Exclusion criteria: Presence of craniofacial deformities; dental agenesis; active carious lesions; and previous orthodontic treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the characteristics of the dental arches (vertical and horizontal crossings, perimeter and length of the upper and lower arches, dental inclination, upper and lower vertical dentoalveolar development and transverse distances) using three-dimensional (3D) models obtained before (baseline), 6 and 12 months after the start of treatment, after Class II correction (by means of advancement or distalization, end of treatment and post-treatment control, using the OrthoAnalyzer program | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate two-dimensional cephalometric characteristics using cephalograms obtained from lateral cephalograms. The measurements will be taken using the Dolphin program to assess 8 cephalometric variables: ANB, SNA, SNB, FMA, 1.NA, 1-NA, 1.NB and 1-NB. For the three-dimensional cephalometric evaluation, the models will be constructed, images will be registered, transparency overlays will be applied, and quantitative measurements will be taken using color maps that calculate the distance between points within the same region of two surfaces. Nineteen anatomical regions that may be influenced by the use of the studied appliances will be analyzed. Measurements will be taken in the area of greatest displacement, both anteriorly and posteriorly;Evaluate the perception of pain and discomfort using the Visual Analog Scale Combination of the Numeric Rating Scale (NRS) and the Facial Pain Scale (FPS) to assess the intensity of daily pain, before the start of treatment (baseline), immediately after the installation of the Intraoral Distalers and precision wigs and during the first seven days after installation. The exams will be repeated at each monthly appointment during the same periods, with the exception of baseline, immediately after and for seven days afterwards, for a total period of six months;Evaluate the behavior of sleep bruxism and wakefulness bruxism through the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) oral habit behavior questionnaire for the diagnosis of sleep bruxism (SB) and awake bruxism (AB);To assess sleep quality and obstructive sleep apnea/hypopnea syndrome. Parents and guardians will answer a questionnaire about the child's behavior over the last month and sleep-related issues (Pediatric Sleep Questionnaire);Evaluate oral function (Nordic Orofacial Test NOT-S - exam) using a test called the Nordic Orofacial test (NOT-S). This test is used when a patient has difficulty speaking, chewing or swallowing;To assess orofacial motricity and | — |
Countries
Brazil
Contacts
Public ContactPaula Oltramari
Universidade Anhaguera - UNIDERP
Outcome results
None listed