Tooth-Borne Versus Tooth-Bone-Borne Rapid Maxillary Expanders: A Stereophotogrammetric Evaluation of Soft Tissues
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 主要终点
- Increasing soft tissue facial measurement-1
研究概览
简要总结
The force exerted by the rapid maxillary expansion (RME) appliances provides expansion of the transverse dimension by splitting of the midpalatal suture. This expansion results in three-dimensional (3D) changes in maxillary position which also effects circummaxillary surrounding structures. The aim of this randomized clinical trial (RCT) was to evaluate the effects of tooth-borne and tooth-bone-borne rapid maxillary expansion (RME) on soft tissue with stereophotogrammetry.
详细描述
Introduction
To evaluate the effects of tooth-borne and tooth-bone-borne rapid maxillary expansion (RME) on soft tissue with stereophotogrammetry. Methods: 32 patients (15 males, 17 females) who met inclusion criteria were divided into two groups. In the first group, tooth-borne RME appliance (Hyrax) was applied to 16 patients (9 males, 7 females mean age 13.4 ± 1.3 years) and in the second group, tooth-bone-borne RME appliance (Hybrid Hyrax) was applied to 16 patients (6 males, 10 females mean age 13.05 ±1.24 years). A simple electronically generated randomization was performed before trial commencement using the Random Allocation Software program. Allocation concealment involved numbered, sealed, and opaque envelopes prepared before trial commencement. One envelope was sequentially opened for each participant during recruitment. Each envelope contained a card with the name of 1 expander. The initials of the name of the participant, the type of expander, and the date of allocation were identified in the external surface of the envelope. One operator was responsible for the randomization process, allocation concealment, and implementation. The primary outcomes of this study was assessment of changes in soft tissues before RME (T0) and post-retention (T1) period by stereophotogrammetry. Independent and dependent sample t tests were used to compare intra- and inter-group differences at P<0.05 significance level.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 14 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No previous tonsillar, nasal or adenoid surgery and orthodontic treatment,
- •Bilateral crossbite and need for RME,
- •Maxillary and mandibular permanent teeth fully erupted,
- •Willingness to participate in the study
排除标准
- •the presence of adenotonsillectomy due to tonsillar hypertrophy or adenoidal hypertrophy
- •Having nasal/nasopharyngeal /oropharyngeal pathologies, craniofacial syndromes, systemic disease, poor oral hygiene,
- •History of previous orthodontic treatment.
结局指标
主要结局
Increasing soft tissue facial measurement-1
时间窗: At baseline and after 3 months retention period
Increasing anterior face height
Increasing soft tissue facial measurement-2
时间窗: At baseline and after 3 months retention period
Increasing upper lip length
Increasing soft tissue facial measurement-3
时间窗: At baseline and after 3 months retention period
Increasing lower face height
次要结局
未报告次要终点
研究者
Gökçenur Gökçe
Assistant professor
Izmir Katip Celebi University
