An interventional study of 2-Segment SARPE and 3-Segment SARPE in Maxillary Hypoplasia, sponsored by Federal University of São Paulo. Status unknown at 1 site in Brazil. Open to participants aged 17 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-03-16.
Sponsored by Federal University of São Paulo · Not applicable and Interventional
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.
Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Maxilla expansion using one sagittal section of the maxilla.
Other: 2-Segment SARPE
Maxilla Expansion using two parasagittal section of the maxilla.
Other: 3-Segment SARPE
Le Fort I osteotomy with oppening of the median palatal suture and SARPE.
Also known as: Surgically Assisted Rapid Maxillary Expansion (SARME), 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.
Also known as: Surgically Assisted Rapid Palatal Expansion (SARPE), Surgically Assisted Rapid MaxillaryExpansion (SARME)
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.
Time frame: An average of 2 weeks after expansion.
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.
Time frame: 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).
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
The nasal and paranasal topographic changes will be captured using laser scanner device.
Time frame: pre-operative,an average of 2 weeks at the end of the expansion, 4 and 12 months after maxillary expansion.
This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Federal University of São Paulo