Effects of early treatment of anterior open bite with orthodontic aligners and removable palatal crib

INTERVENTION: 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), ClearCorrectTM orthodontic aligners, Straumann, Curitiba, Paraná, Brazil; 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 who meet the following criteria will be included in the study: 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 first permanent molars . Exclusion criteria will be: presence of craniofacial deformities, absence of permanent teeth, severe crowding, posterior crossbite or previous orthodontic treatment. All the patients included in the sample will carry out orthodontic documentation containing intra and extraoral photographs; 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; cephalometric characteristics; presence of bacterial plaque; presence of metabolites in saliva; pain and discomfort; bruxism behavior sleep and wakefulness; child and mother caregiver anxiety; childhood stress; sleep quality and obstructive sleep apnea/hypopnea syndrome; oral function; occlusal contacts; orofacial motricity and speech production and/or perception; quality of life related to oral health (QHRSB); cooperation and satisfaction with treatment; oral health literacy of guardians; color s CONDITION: C07.793.494 Openbite PRIMARY OUTCOME: 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 OUTCOME: To evaluate complications throughout the treatment through access to the medical records related to the treatment will be noted in the medical record, such as: missed appointments, withdrawals, little use of the device, soft tissue injuries, loss or breakage of device, need of adjustment. These data will be evaluated at the end of the study to compare the percentage of complications in each group. To evaluate the adhesion and dimensional stability of the resin attachments comparing the scans performed by means of the intraoral scanner right after the installation of the attachments and after 3, 6, 9 and 12 months. To evaluate the anxiety level of caregivers of children using a self‐report questionnaire that assesses trait anxiety (STAI‐T) 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 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 child stress using the child stress scale (ESI) To evaluate the children's anxiety level using the state trait anxiety questionnaire for children (Brazilian version of STAI‐C) To evaluate the color stability of the aligners: patients in the AO group will have the aligners evaluated for color, before installation and after continuous use for 10 days, the period established for replacement with new aligners, throughout the treatment. The evaluation will be performed using an x‐rite PantoneTM spectrophotometer (model SP2034). To evaluate the degree of cooperation of patients using the Orthodontic Patient Cooperation Scale (OPCS),36 which measures the cooperation of patients through their attitudes and attendance at appointments. To evaluate the impact on the Quality of Life Related to Oral Health (QHRSB) of the treatment performed by a specific instrument (CPQ 8‐10) ; To evaluate the level of Literacy in Oral Health (LSB) of those responsible for the volunteers using the Brazilian Rapid Estimate of Adult Literacy in Dentistry (BREALD‐30) and Health Literacy in Dentistry (HeLD‐14) instruments39. Then, the existence of associations between LSB and behavioral stages and dental clinics in the studied groups will be verified. To evaluate the occlusal contact points: The occlusal contacts will also be registered for both research groups using an eight‐micron strip of carbon paper (AccuFilm ‐ USA). To evaluate the oral function (Nordic Orofacial Test NOT‐S – examination) by means of a test called Nordic Orofacial test (NOT‐S). This test is used when a patient has difficulty speaking, chewing, or swallowing. To evaluate the orofacial motricity and speech production and/or perception according to the Orofacial Myofunctional Assessment Protocols with Scores (AMIOFE) and the MBGR Protocol (Marchesan, Berrentin‐Felix, Genaro, Rehder). speech, considering linguistic and psychometric criteria. These exams will be performed by a speech therapist who is part of the research team before, si Xmonths after the beginning and at the end of the orthodontic treatment. To evaluate the patient satisfaction with treatment using a specific instrument proposed by Bos et al. 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 si Xmonths. 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 presence of bacterial plaque before, after 6 months and 12 months from the start of treatment, using the Simplified Oral Hygiene Inde X(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 sleep and wakefulness bruxism behavior using the DC/TMD oral habits questionnaire for the diagnosis of sleep (SB) and wakefulness (BV) bruxism. To evaluate the sleep quality and obstructive sleep apnea/hypopnea syndrome: those responsible will answer an instrument referring to the child's behavior during the last month, on questions related to sleep (pediatric sleep questionnaire). 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