Malocclusion Clinical Trial
Official title:
Maxillary Expander With Differential Opening Versus Fan-type Expander: a Randomized Clinical Trial
This study will assess the dentoskeletal effects of two types of maxillary expanders in orthodontic patients in the mixed dentition, from 7 to 11 years old. Half of participants will be treated using the expander with differential opening, while the other half will undergo rapid maxillary expansion using the fan-type expander. The null hypothesis is that there is no difference between dentoskeletal effects of the two protocols.
Rapid maxillary expansion (RME) is the orthopedic procedure of choice to treat maxillary
constriction and posterior crossbite, and the study of dental, skeletal and periodontal
effects of this procedure has been widely discussed in the orthodontic literature. The
conventional RME expanders promote a similar expansion in the anterior and posterior regions
of the maxillary arch. On the other hand, the fan-type expander allows the expansion
concentrated in the intercanine region with little effects the intermolar distance. Finally,
the expander with differential opening has two palatal screws and the differential activation
protocol promotes a different amount of expansion for the anterior and posterior regions of
the maxilla. No clinical study compared dental and skeletal effects of the expander with
differential opening with those of the fan-type expander, including a three-dimensional
analysis using CBCT exams and digital dental models. So, the aim of the present randomized
clinical trial is to compare the skeletal and dentoalveolar effects of the maxillary expander
with differential opening and the fan-type expander in the mixed dentition.
For this, patients will be recruited at the Orthodontic Clinic of Bauru Dental School,
University of São Paulo, Brazil. A sample of 48 patients from 7 to 11 years old with
transverse maxillary dental arch constriction will be prospectively and randomly allocated
into two study groups. The first group will consist of 24 individuals treated with the
expander with differential opening (DEG). The second group will consist of 24 individuals
treated with the fan-type expander (FEG). In 12 patients from each group (immediate
subgroups), a cone-beam computed tomography (CBCT) will be performed in the beginning of
treatment (T1) and immediately after the rapid maxillary expansion (T2). In the other 24
patients, 12 from DEG and 12 from FEG (late subgroups), a CBCT will be obtained at T1 and 6
months after maxillary expansion (T3). Dental models will be obtained for all patients at T1
and T3. In digital dental models, maxillary arch width, perimeter, length and shape will be
assessed. Standardized CBCT coronal sections will be used for measuring maxillary transverse
dimensions, nasal cavity width and posterior tooth inclinations. Segmentation and
superimposition of T1 and T3 CBCT images at the cranial base will be also performed. The
opening of the midpalatal suture at the anterior and posterior region and the geometry of the
suture opening will be evaluated in axial reconstructions of the CBCT.Discomfort, pain and
quality of life will be evaluated by questionnaires.
After the normality test, the paired t test will be used in the intragroup comparison, and
the independent t test will be used in the intergroup comparison. In the case of lost to
follow-up patients, intention to treat analysis will be used. A significance level of 5% will
be regarded for all tests.
Possible harms that could appear are related to temporary discomfort during the first days
after the installation of the expander. Patients and legal guardians will be carefully
oriented and they will be able to stop the treatment at any moment.
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