Clinical trial NCT02810353: Analysis of the Dentoskeletal Effects of the Expander With Differential Opening
Official title: Analysis of the Dentoskeletal Effects of the Expander With Differential Opening: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillary Constriction
Unilateral Posterior Crossbite
Bilateral Posterior Crossbite
Mandibular Dental Arch Constriction
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the dentoskeletal effects of the expander with differential opening in orthodontic patients in the mixed dentition. Half of participants will undergo rapid maxillary expansion (RME) using the expander with differential opening, while the other half will undergo RME using the conventional Hyrax expander.

Detailed description: Recently, a rapid maxillary expander with differential opening was developed aiming to treat maxillary constrictions greater in the anterior region compared to the posterior region of the maxillary dental arch. The aim of this study is to evaluate the dentoskeletal effects of the expander with differential opening in orthodontic patients in the mixed dentition. Material and methods: Fifty patients with maxillary constriction in the mixed dentition will be prospectively and randomly allocated in one of two study groups. The experimental group will comprise 25 patients who will be submitted to rapid maxillary expansion with the expander with differential opening. The control group will be comprised by 25 individuals who will undergo rapid maxillary expander with the Hyrax expander. Digital dental models will be acquired immediately pre-expansion (T1) and six months post-expansion (T2). The Orthoanalyzer™ software will be used to measure maxillary and mandibular widths, arches perimeter, arches lengths, palatal depth, and inclinations of maxillary and mandibular canines and permanent first molars. The intergroup and interphase comparisons will be analyzed using t tests and paired t tests, respectively (p\<0.05).

Eligibility criteria: Inclusion Criteria:

* Both sexes;
* Ages ranging from 7 to 11 years old;
* Mixed dentition;
* Maxillary constriction;
* No previous orthodontic treatment.

Exclusion Criteria:

* Cleft lip and palate and associated syndromes;
* Systemic and/or neurological diseases.

Primary outcomes:
measure: Maxillary and mandibular inter-first permanent molar distances
timeFrame: 6 months
measure: Maxillary and mandibular inter-second deciduous molar distances
timeFrame: 6 months
measure: Maxillary and mandibular inter-first deciduous molar distances
timeFrame: 6 months
measure: Maxillary and mandibular inter-deciduous canine distances
timeFrame: 6 months
measure: Maxillary and mandibular dental arches perimeters
timeFrame: 6 months
measure: Maxillary and mandibular dental arches lengths
timeFrame: 6 months
measure: Palatal depth
timeFrame: 6 months
measure: Inclination of maxillary and mandibular first permanent molars
timeFrame: 6 months
measure: Inclination of maxillary and mandibular deciduous canines
timeFrame: 6 months
measure: Amount of interincisor diastema
timeFrame: 10 days
Secondary outcomes:
measure: Amount of differential expansion on the maxillary and mandibular dental arches
timeFrame: 6 months
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: University of São Paulo
state: São Paulo
Study officials:
affiliation: Bauru Dental School, University of São Paulo
name: Arthur Alves, DDS, MSc
role: PRINCIPAL_INVESTIGATOR
References: