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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Maxillary Hypoplasia

Intervention / Treatment
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* Other: 2-Segment SARPE
* Other: 3-Segment SARPE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 2-Segment SARPE<br>Maxilla expansion using one sagittal section of the maxilla. | Other: 2-Segment SARPE<br>* Le Fort I osteotomy with oppening of the median palatal suture and SARPE.<br>* Other names: Surgically Assisted Rapid Palatal Expansion (SARPE);|
| Other: 3-Segment SARPE<br>Maxilla Expansion using two parasagittal section of the maxilla. | Other: 3-Segment SARPE<br>* Le Fort I osteotomy with two parallel osteotomies symetrically positioned with reference to the median palatal suture and SARPE.<br>* Other names: Surgically Assisted Rapid MaxillaryExpansion (SARME);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maxillary expansion, Orthognathic surgery, Symmetry, Palatal expansion technique, Maxilla abnormality