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临床试验/CTRI/2024/10/075097
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

发起方
Dr Bini KK
申办方类型
Other [self funded]

研究点 (1)

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