This trial is active, not recruiting.

Condition maxillary hypoplasia
Treatments 2-segment sarpe, 3-segment sarpe
Sponsor Federal University of São Paulo
Start date September 2013
End date August 2016
Trial size 50 participants
Trial identifier NCT02179593, 464.869


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Maxilla expansion using one sagittal section of the maxilla.
2-segment sarpe Surgically Assisted Rapid Maxillary Expansion (SARME)
Le Fort I osteotomy with oppening of the median palatal suture and SARPE.
Maxilla Expansion using two parasagittal section of the maxilla.
3-segment sarpe Surgically Assisted Rapid Palatal Expansion (SARPE)
Le Fort I osteotomy with two parallel osteotomies symetrically positioned with reference to the median palatal suture and SARPE.

Primary Outcomes

Quality of Life
time frame: An average of 2 weeks after expansion.

Secondary Outcomes

Maxillary symmetry
time frame: pre-operative and an average of 2 weeks at the end of maxillary expansion.
Stability of dental and osseous structures
time frame: pre-operative, an average of 2 weeks at the end of the expansion, 4 months, 1 and 2 years after maxillary expansion.
Nasal and paranasal topographic changes
time frame: pre-operative,an average of 2 weeks at the end of the expansion, 4 and 12 months after maxillary expansion.

Eligibility Criteria

Male or female participants from 17 years up to 50 years old.

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.

Additional Information

Official title Effectiveness of Surgically Assisted Rapid Palatal Expansion (SARPE) With 3 and 2-Segment Technique: A Randomized Clinical Trial
Principal investigator Max D Pereira, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.