Effectiveness of SARPE With 3 and 2-Segment Technique: A Randomized Clinical Trial
This trial is active, not recruiting.
|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.
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Quality of Life
time frame: An average of 2 weeks after expansion.
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.
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.
|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.|
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