Openbite
Conditions
Interventions
This study will be a parallel-type randomized clinical trial, in which participants from each group will be prospectively recruited and randomly divided into 2 study groups: AO (n = 25), ClearCorrectT
RPC (n = 25), removable palatal crib. Patients will be assessed before (baseline), throughout treatment (3, 6, 9 and 12 months), end of treatment (positive TV) and post-treatment control. Volunteers w
panoramic radiographs and lateral radiography (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). The following parameters will be evaluated: characteristics of the dental arches
presence of metabolites in saliva
bruxism behavior sleep and wakefulness
child and mother caregiver anxiety
quality of life related to oral health (QHRSB)
color s
Sponsors
Universidade Anhaguera - UNIDERP
Universidade Anhaguera - UNIDERP
Eligibility
Age
7 Years to 10 Years
Inclusion criteria
Inclusion criteria: Age between 7 and 10 years; Angle Class I malocclusion; anterior open bite (AOB) equal to or greater than 1 mm; erupted central incisors and upper and lower permanent first molars; both sexes
Exclusion criteria
Exclusion criteria: Presence of craniofacial deformities; absence of permanent teeth; severe crowding; posterior crossbite or previous orthodontic treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the overbite correction in millimeters using 3D models obtained before (baseline), throughout treatment (3, 6, 9 and 12 months), end of treatment (positive TV) and post-treatment control, which will be evaluated by OrthoAnalyzer program. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the characteristics of the premature arches (horizontal overlap, perimeter and length of the upper and lower arches, dental information, upper and lower vertical dentoalveolar development and transverse distances) through the 3D models obtained before (baseline), throughout the treatment (3 , 6, 9 and 12 months), end of treatment (positive VT) and post-treatment control, using the OrthoAnalyzer program.;To evaluate the cephalometric characteristics using cephalograms obtained from lateral radiographs. The measurements will be taken in the Dolphin program, for the evaluation of 8 cephalometric variables: ANB, SNA, SNB, FMA, 1.NA, 1-NA, 1.NB and 1-NB.;To evaluate the presence of bacterial plaque before, after 6 months and 12 months from the start of treatment, using the Simplified Oral Hygiene Index (SOI).;To evaluate the presence of metabolites in saliva by collecting unstimulated saliva before and after using the devices (1, 3 and 6 months). Saliva samples will be submitted to ultra-performance liquid chromatography (UPLC), energy-dispersive X-ray fluorescence analysis (EDX-RF) and nuclear magnetic resonance spectroscopy (NMR).;To evaluate the perception of pain and discomfort using two analyses: 1. Visual analogue scale (VAS) and 2. Combination of numeric rating scale (NRS) and facial pain scale (FPS) to assess pain intensity daily . These records will be made before the start of treatment (baseline), immediately after installation of the devices and during the first days after installation. The exams will be repeated at each monthly visit in the same periods, with the exception of the baseline, immediately after and during the following seven days, in a total period of six months. Parents or guardians will be instructed to measure pain and need for painkillers. The child's pain response should always be assessed at the same time of day.;To evaluate the sleep and wakefulness bruxism behavior using the DC/TMD oral habits questionnaire for the diagnosis o | — |
Countries
Brazil
Contacts
Public ContactPaula Oltramari
Universidade Anhaguera - UNIDERP
Outcome results
None listed