CTRI/2024/10/075097尚未招募不适用
Comparative Evaluation of the Skeletal, Dentoalveolar and Dental Changes Following Maxillary Skeletal Expansion Using Expanders of Two Different Designs –A Randomized Clinical Trial
Dr Bini KK1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年1月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Amount of Maxillary Skeletal Expansion Assessed by Change in Midpalatal Sutural Width
研究概览
简要总结
The aim of the study is to comparatively evaluate skeletal, dental and dentoalveolar changes after maxillary skeletal expansion using two different designs of tooth bone-borne expanders in adolescent patients by Cone beam computed tomography (CBCT). 24 patients will be recruited based on inclusion and exclusion criteria and randomly allocated to intervention/ comparator groups. After achieving maxillary skeletal expansion, primary and secondary outcomes will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 13.00 Year(s) 至 21.00 Year(s)(—)
- 性别
- All
入选标准
- •(1)presence of transverse skeletal maxillary deficiency with or without the presence of posterior crossbite as described by Penn CBCT transverse analysis (2)incomplete radiographic ossification of the mid palatal suture according to Angelieri’s classification (3) bilateral presence of first and second upper premolars and first upper molars .
排除标准
- •(1)Those with any craniofacial irregularities, and any bone defects, (2) those who have received previous orthodontic / orthopedic treatment (3) patients with systemic and periodontal disease (4) those with a portion of suture where fusion has occurred ( stage E in accordance with Angilieri’s classification) and with no low- density spaces along the suture.
结局指标
主要结局
Amount of Maxillary Skeletal Expansion Assessed by Change in Midpalatal Sutural Width
时间窗: Three months
次要结局
- 1.Change in Nasal Width(2.Change in Alveolar Bone Thickness)
研究者
研究点 (1)
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