Maxillary Hypoplasia
Conditions
Keywords
Maxillary expansion, Orthognathic surgery, Symmetry, Palatal expansion technique, Maxilla abnormality
Brief 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.
Interventions
OTHER2-Segment SARPE
Le Fort I osteotomy with oppening of the median palatal suture and SARPE.
OTHER3-Segment SARPE
Le Fort I osteotomy with two parallel osteotomies symetrically positioned with reference to the median palatal suture and SARPE.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | An average of 2 weeks after expansion. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maxillary symmetry | pre-operative and an average of 2 weeks at the end of maxillary expansion. | The maxillary symmetry will be assessed by analyzing before and after 3D imaging obtained from computed tomography data , superimposed using the Geomagic Qualify software. |
| Stability of dental and osseous structures | pre-operative, an average of 2 weeks at the end of the expansion, 4 months, 1 and 2 years after maxillary expansion. | 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). |
| Nasal and paranasal topographic changes | pre-operative,an average of 2 weeks at the end of the expansion, 4 and 12 months after maxillary expansion. | The nasal and paranasal topographic changes will be captured using laser scanner device. |
Countries
Brazil
Outcome results
None listed