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Effectiveness of SARPE With 3 and 2-Segment Technique: A Randomized Clinical Trial — 3S/2S_SARPE  

Maxillary Hypoplasia Clinical Trial

Official title:
Effectiveness of Surgically Assisted Rapid Palatal Expansion (SARPE) With 3 and 2-Segment Technique: A Randomized Clinical Trial

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02179593
Study type Interventional
Source Federal University of São Paulo
Contact
Status Active, not recruiting
Phase N/A
Start date September 2013
Completion date December 2016
View Details
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