Class II division 1 malocclusion
Conditions
Interventions
This is a randomized, controlled, blinded, four-arm clinical trial. Initially, the "
Random Allocation software 2.0"
program was applied to randomize the children who will participate in the first and second years of treatment, with 20 in each group. Simple randomization was performed in random blocks of 2 and 4. Al
Sponsors
Faculdade de Odontologia da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
7 Years to 8 Years
Inclusion criteria
Inclusion criteria: Age range between 7 and 8 years; both sexes; may or may not present with mild or moderate apnea and/or hypopnea; who are in the mixed dentition phase; with all four upper and lower permanent incisors and first molars erupted; in addition to still having at least the four upper and lower deciduous molars; who present with an increase in the lower third in relation to the middle third of the face; mandibular retrusion and a decrease in the transverse dimensions of the upper arch
Exclusion criteria
Exclusion criteria: Individuals with decayed teeth or teeth requiring extensive treatment or with periodontal disease; those with temporomandibular dysfunction; rheumatoid arthritis; those using medication that interferes with growth; those with severe sleep apnea; or whose general health condition contraindicates orthodontic treatment; those with congenital problems involving the temporomandibular joint (TMJ) and/or the cranial, orofacial, and cervical regions; those who are unavailable to participate in the study or unable to answer the quality of life questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: Change in S.N.B Angle. In this study, the change in the S.N.B. angle will be measured between baseline and after one year of treatment in both study groups. Changes in this cephalometric measurement will be evaluated using cephalometric radiographs performed at the beginning of the study and after one year of treatment. A significant change in the S.N.B. angle is expected, allowing us to assess the effect of the treatment on the direction of excessive vertical facial growth, resulting in anterior chin displacement | — |
Secondary
| Measure | Time frame |
|---|---|
| This study will investigate the prevalence of snoring, sleep apnea, and hypoventilation using the apnea-hypopnea index (AHI) at the beginning of treatment; at the end of the active disjunction phase; and after 1 year of treatment, comparing the treatment and control groups;This study will evaluate the influence of low-power laser photobiomodulation therapy on the opening rate of the median palatine suture in participants; on bone formation in the median palatine suture; on the variation in the thickness of the vestibular bone plate in the upper molar region after treatment to control vertical facial growth using maxillary tomography;The patency of the upper airways will be assessed by means of acoustic rhinometry and rhinomanometry at the beginning and after one year of treatment. The results of the acoustic rhinometry examination will be described by means of graphs, called rhinograms. Total nasal respiratory resistance (TRR) will be calculated using the parallel resistance formula, where TRR is equal to right nasal resistance (RDR) multiplied by left nasal resistance (LNR), divided by the sum of the same, as described by McCaffrey & Kern (1979) and Principatto et al (1986);Craniofacial changes will be evaluated in all three planes of space, comparing cephalometric measurements focused on the study of skeletal, dental, integumentary, and airway structures, based on extended facial computed tomography scans and photographs obtained at the beginning and after one year of treatment.;The relationships between the dental arches will be evaluated using models mounted on a semi-adjustable articulator at the beginning and end of the study, comparing the anteroposterior relationships between them, the anterior overbite and overjet.;The mandibular positions of RC and MIH will be analyzed using the Panadent Condylar Position Indicator (CPI), measuring the displacement of the mandibular heads in the three planes of space, at the beginning, at the end, and between the begin | — |
Countries
Brazil
Contacts
Public ContactSolange Fantini
Faculdade de Odontologia da Universidade de São Paulo
Outcome results
None listed