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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-Segment SARPE | Other | Maxilla expansion using one sagittal section of the maxilla. |
|
| 3-Segment SARPE | Other | Maxilla Expansion using two parasagittal section of the maxilla. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-Segment SARPE | Other | Le Fort I osteotomy with oppening of the median palatal suture and SARPE. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | The primary outcome chosen in this study is Quality of Life assessed through the Orthognathic Quality of Life Questionaire (OQLQ) and Oral Health Impact Profile (OHIP-49) currently available in Portuguese language and validated for scientific studies. | An average of 2 weeks after expansion. |
| Measure | Description | Time Frame |
|---|---|---|
| Maxillary symmetry | The maxillary symmetry will be assessed by analyzing before and after 3D imaging obtained from computed tomography data , superimposed using the Geomagic Qualify software. | pre-operative and an average of 2 weeks at the end of maxillary expansion. |
| Stability of dental and osseous structures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Max D Pereira, PhD | Federal University of São Paulo | Principal Investigator |
| Gabriela PR Prado, MS | Federal University of São Paulo | Study Chair |
| Fabianne MG Furtado, PhD | Federal University of São Paulo | Study Chair |
| Lydia M Ferreira, PhD | Federal University of São Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Sao Paulo | São Paulo | São Paulo | 04024002 | Brazil |
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| ID | Term |
|---|---|
| D063173 | Retrognathia |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
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| 3-Segment SARPE | Other | Le Fort I osteotomy with two parallel osteotomies symetrically positioned with reference to the median palatal suture and SARPE. |
|
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The stability of dental and osseous structures will be analyzed using computer-aided 3D analysis of data obtained through the scanning of dental casts using Bicam 3D scanner (Scaierman - Italy). |
| 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 | The nasal and paranasal topographic changes will be captured using laser scanner device. | pre-operative,an average of 2 weeks at the end of the expansion, 4 and 12 months after maxillary expansion. |
| D019465 |
| Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D008336 | Mandibular Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |