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

Federal University of São Paulo

Status: Unknown

Conditions: Maxillary Hypoplasia

Treatments: Other: 3-Segment SARPE; Other: 2-Segment SARPE

Study type: Interventional

Funder types: Other

Identifiers

NCT02179593

464.869

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 17 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups

2-Segment SARPE

Other group

Description:

Maxilla expansion using one sagittal section of the maxilla.

Treatment:

Other: 2-Segment SARPE

3-Segment SARPE

Other group

Description:

Maxilla Expansion using two parasagittal section of the maxilla.

Treatment:

Other: 3-Segment SARPE