Orthodontics, Interceptive
Conditions
Interventions
The study design will be an interventional, prospective, randomized clinical trial, with participant allocation performed through simple randomization in a 1:1 ratio, using opaque, sealed envelopes. B
masking will be open. In total, 28 participants will be recruited, with 14 in each group. Intervention Group: The 14 participants, of both sexes, will receive the Invisalign Palatal Expander System (A
Sponsors
Universidade do Estado do Rio de Janeiro - UERJ
Universidade do Estado do Rio de Janeiro - UERJ
Eligibility
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: Age between 6 and 12 years; both sexes; mixed dentition stage; Class I or Class II molar relationship, or straight/mesial step in the primary dentition; cervical vertebral stage 1 or 2 (CVS methods 1–2); unilateral or bilateral posterior crossbite, involving primary or permanent teeth; patients diagnosed with transverse maxillary deficiency, characterized by a skeletal transverse discrepancy measured from the estimated center of resistance of the first molars = –3 mm
Exclusion criteria
Exclusion criteria: Previous orthodontic treatment; patients with skeletal Class III; dental agenesis or presence of supernumerary teeth; craniofacial abnormalities; maxillary tooth impaction; presence of palatal torus; history of dental trauma, including avulsion and alveolar/maxillary fracture; refusal to sign the informed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skeletal transverse changes are expected, including variations in arch width and shape, molar inclination, palatal area and volume, as well as changes in periodontal condition. These modifications will be assessed through measurements obtained from imaging exams and digital analyses, using parameters such as linear and angular measurements, volumetric values, and periodontal indices to confirm the occurrence of the expected changes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Variations are expected in pain perception, assessed using the Faces Pain Scale; in patient quality of life, measured by the CPQ8–10 and QVRSB questionnaires; and in parental anxiety levels. These variations will be evaluated through the standardized application of the assessment instruments and the analysis of images obtained from cone-beam computed tomography (CBCT) and digital model superimposition. The parameters will include questionnaire scores, three-dimensional structural changes, and quantitative measurements derived from the images to confirm the occurrence of the expected changes. | — |
Countries
Brazil
Contacts
Public ContactJosé Augusto Miguel
Universidade do Estado do Rio de Janeiro - UERJ
Outcome results
None listed