Comparison of Maxillary Dental Expansion Using Smartee Clear Aligner With and Without S11 Expander: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- comparison the effect of S11 expander with conventional one
研究概览
简要总结
To compare the effects of Smartee S11 expander with conventional clear aligner expansion using cone beam computed tomography (CBCT).
The secondary objective is to evaluate the degree of orthodontic expansion and the type of tooth movement achieved with Smartee aligners on the maxillary arch.
详细描述
Each patient will be randomly allocated, and the entire patient included in this study will be divided into two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- healthy cooperative female and male patients who will undergo maxillary expansion with Smartee aligners, A young adult/adult patients starting from age of 18 up to 35 years old.
- •2- patients with maxillary compression of non-skeletal origin, moderate dental crowding in the upper arch (4-8mm). 3- patients with unilateral or bilateral crossbite, patients will be treated with intermaxillary elastics without distalization or mesialization of the dental arches.
- •4- patients with sufficient clinical crown height (greater than 4 mm), no mesial rotation of the upper first molar. 5- there is good compliance during the treatment (wearing aligners for 20 hours per day).
- •6- good quality x-rays with appropriate visualization of landmarks and control of head rotation. 7- absence of periodontal disease, and absence of previous prosthodontic treatments of the upper molars.
排除标准
- •1- signs and/or symptoms of temporomandibular abnormalities (TMDs). 2- active periodontal disease. 3- prosthodontic rehabilitations of the maxillary molar or ankylosed teeth, and endodontic treatments of the maxillary molars. 4- patients requiring orthognathic surgery
研究组 & 干预措施
group 1
with conventional expander
干预措施: conventional expantion (Device)
group 2
with S11 expander
干预措施: maxillary expander with transpalatal strap S11 (Device)
结局指标
主要结局
comparison the effect of S11 expander with conventional one
时间窗: from the enrollment to the end of expansion at 6 months
To compare the effects of Smartee S11 expander with conventional clear aligner expansion using cone beam computed tomography (CBCT).
次要结局
未报告次要终点
研究者
Aisha Ali Qahtani
postgraduate student
King Abdulaziz University