NCT02179593

Effectiveness of SARPE With 3 and 2-Segment Technique: A Randomized Clinical Trial

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 17 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Maxillary Hypoplasia

Interventions

Type	Name	Description
OTHER	2-Segment SARPE	Le Fort I osteotomy with oppening of the median palatal suture and SARPE.
OTHER	3-Segment SARPE	Le Fort I osteotomy with two parallel osteotomies symetrically positioned with reference to the median palatal suture and SARPE.

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-08-01
• Completion: 2016-12-01
• First posted: 2014-07-02
• Last updated: 2016-03-16

Locations

1 site across 1 country: Brazil