Clinical trial NCT02179593: Effectiveness of SARPE With 3 and 2-Segment Technique: A Randomized Clinical Trial
Official title: Effectiveness of Surgically Assisted Rapid Palatal Expansion (SARPE) With 3 and 2-Segment Technique: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillary Hypoplasia
Keywords: Maxillary expansion
Orthognathic surgery
Symmetry
Palatal expansion technique
Maxilla abnormality
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 50
Sex: ALL
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: A few studies state that 3-segment SARPE has the following advantages: a) higher level of expansion symmetry; b) higher level of stability of the expansion achieved; and c) faster bone healing. The investigators hypothesize that 2-segment SARPE is as effective as 3-segment SARPE concerning treatment and/or quality of life in daily practice.

Detailed description: 32 healthy, literate adult patients (male and female) with 7-millimeter transverse maxilla deficiency bilaterally distributed will participate in this study.

The participants will be assigned randomizable in equal number to undergo either 3-segment or 2-segment SARPE.

Individuals that a) have undergone maxilla surgery previously; b) have craniofacial anomaly;and c) have dental crowding will not be enrolled.

All participants will be assessed before and after surgery for sensitivity to pressure and temperature in the innervated structures linked to the maxilla, as well as for quality of life using OHIP-49 and B-OQLQ assessment tools.

The expansion of maxilla will be assessed by superimposing tomographic images before and after surgery.

Eligibility criteria: Inclusion Criteria:

* Being healthy and literate
* Having 7-millimeter transverse maxilla deficiency bilaterally distributed.

Exclusion Criteria:

* Having undergone maxilla surgery previously
* Having craniofacial anomaly
* Having excessive dental crowding.

Primary outcomes:
measure: Quality of Life
timeFrame: An average of 2 weeks after expansion.
Secondary outcomes:
measure: Maxillary symmetry
timeFrame: pre-operative and an average of 2 weeks at the end of maxillary expansion.
measure: Stability of dental and osseous structures
timeFrame: pre-operative, an average of 2 weeks at the end of the expansion, 4 months, 1 and 2 years after maxillary expansion.
measure: Nasal and paranasal topographic changes
timeFrame: pre-operative,an average of 2 weeks at the end of the expansion, 4 and 12 months after maxillary expansion.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Max D Pereira, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Gabriela PR Prado, MS
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Fabianne MG Furtado, PhD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Lydia M Ferreira, PhD
role: STUDY_CHAIR
References: