Effectiveness of Surgically Assisted Rapid Palatal Expansion (SARPE) With 3 and 2-Segment Technique: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Quality of Life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being healthy and literate
- •Having 7-millimeter transverse maxilla deficiency bilaterally distributed.
排除标准
- •Having undergone maxilla surgery previously
- •Having craniofacial anomaly
- •Having excessive dental crowding.
研究组 & 干预措施
2-Segment SARPE
Maxilla expansion using one sagittal section of the maxilla.
干预措施: 2-Segment SARPE (Other)
3-Segment SARPE
Maxilla Expansion using two parasagittal section of the maxilla.
干预措施: 3-Segment SARPE (Other)
结局指标
主要结局
Quality of Life
时间窗: 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.
次要结局
- Maxillary symmetry(pre-operative and an average of 2 weeks at the end of maxillary expansion.)
- 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.)
- 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.)
研究者
Max Domingues Pereira
MD, PhD
Federal University of São Paulo