Comparison Between Two Activation Protocols of Miniscrew-Supported Maxillary Expander in Adolescents: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Transverse skeletal changes from baseline to an average of 5 months after the initial activation, measured using cone beam computed tomography (CBCT)
研究概览
简要总结
Miniscrew-supported maxillary expanders provide advantages over conventional tooth-supported expanders. However, there is no consensus in the literature regarding their activation protocol. The purpose of the clinical trial is to evaluate and compare the effects of slow and rapid activation rates of miniscrew-supported expanders on the skeletal changes, dento-alveolar changes and the pain experience.
详细描述
Transverse maxillary deficiency is one of the problems that are commonly encountered in the orthodontic practice. Miniscrew-supported maxillary expansion represents a promising modality for the treatment of transverse maxillary deficiency. However, controversies still exist regarding the activation protocol. One of these controversies is whether using a slow activation protocol would be more beneficial to the patients compared to a rapid activation protocol. Another question that consequently ensues is whether such activation protocol would result in less pain compared to the rapid activation protocol.
The null hypothesis of the current study is that there is no difference between slow and rapid activation protocols of miniscrew-supported expander.
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
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Permanent dentition.
- •Participants indicated for skeletal maxillary expansion due to unilateral or bilateral posterior cross bite or maxillary transverse deficiency
- •Good oral hygiene
排除标准
- •History of previous orthodontic or orthopedic treatment
- •History of maxillary trauma
- •Patients with congenital craniofacial malformations
- •Patients receiving pharmacological agents or having systemic diseases that might affect the bone metabolism or the pain response
研究组 & 干预措施
Slow maxillary expansion
The miniscrew-supported maxillary expander is activated by turning the expansion screw once every other day.
干预措施: Miniscrew-Supported Maxillary Expander- Slow activation (Device)
Rapid maxillary expansion
The miniscrew-supported maxillary expander is activated by turning the expansion screw twice daily.
干预措施: Miniscrew-Supported Maxillary Expander- Rapid activation (Device)
结局指标
主要结局
Transverse skeletal changes from baseline to an average of 5 months after the initial activation, measured using cone beam computed tomography (CBCT)
时间窗: At baseline and an average of 5 months after the initial activation
The data from CBCT scans at the different time points will be exported in Digital Imaging and Communications in Medicine (DICOM) format and processed using suitable software. The relevant landmarks will be defined and located by the investigator to measure the transverse skeletal changes in mm from baseline to the end of passive retention of the expansion.
Dento-alveolar inclination changes from baseline to an average of 5 months after the initial activation, measured using CBCT
时间窗: At baseline and an average of 5 months after the initial activation
The data from CBCT scans at the different time points will be exported in DICOM format and processed using suitable software. The relevant landmarks will be defined and located by the investigator to measure the changes in dento-alveolar inclination from baseline to the end of passive retention of the expansion.
次要结局
- Pain score on NRS after the first activation of the maxillary expander(On day 1 after the first activation of the maxillary expander)
- Pain score on Numeric Rating Scale (NRS) at baseline(Baseline)
- Pain score on NRS after 1 week of activation of the maxillary expander(After 1 week of activation of the maxillary expander)
- Pain score on NRS after the last activation of the maxillary expander(At the end of active expansion (an estimated average of 2 to 3 weeks in the rapid expansion group, and 7 to 12 weeks in the slow expansion group))
研究者
Yomna Mohamed Mohamed Yacout
Assistant lecturer
Alexandria University