Comparison of Two Tooth-borne Expanders in Rapid Maxillary Expansion: Dentoalveolar Effects and Impact on Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Maxillary first molars width. Scale in millimeters and one decimal place.
研究概览
简要总结
This study will assess the dentoalveolar effects and impact on quality of life of two types of maxillary expanders in orthodontic patients with permanent dentition, from 12 to 16 years old. Half of participants will be treated using the Hyrax expander, while the other half will use the mini Hyrax expander. The null hypothesis is that there is no difference between dentoalveolar effects and impact on quality of life of the two protocols.
详细描述
Transverse maxilla deficiency is characterized by narrowing of the maxillary arch with important functional and esthetic impact. In individuals which have not reached bone maturity, a rapid expansion of the maxilla by using tooth-borne expanders as Haas and Hyrax appliance are efficient and safe. A presentation of favorable results for the "mini-Hyrax inverted" expander with a small screw in the transversal correction of the maxilla in patients with cleft lip and palate, besides improving the comfort and the teeth cleaning, provoked an idea of application of this small screw to correct posterior crossbite in individuals without cleft lip and palate. The objective of this study is to compare the dentoalveolar effects and impact on quality of life of two types of maxillary expanders in adolescent patients with permanent dentition and active bone growth. The sample size calculation indicated a total sample of 28 individuals. Taking into account the loss of sample during the study, 34 subjects that have posterior crossbite and age from 12 to 16 years, will be recruited at the Dental School, Pontifical University Catholic of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil. These patients will be randomly divided into two groups, Hyrax and mini Hyrax, with 17 patients each. Digital models of both dental arches will be obtained by intraoral scanning precede the procedure (T0) and at the end of the retention period, after appliance removal (T2). OHIP-14 Oral Health Impact Profile Questionnaires, validated in Portuguese, will be applied before expansion (T0), after an expansion (T1) and at the end of the retention period (T2). In digital dental models, maxillary first and second bicuspids and first molar width, and rotation and inclination of maxillary first bicuspids and first molars will be assessed. After the normality test, the appropriate statistical test will be used in the intergroup comparison. A significance level of 5% will be regarded for all tests.
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
- •Maxillary permanent dentition, except canines
- •Ages ranging from 12 to 16 years old;
- •Maxillary constriction associated to posterior crossbite uni or bilateral.
排除标准
- •Cleft lip and palate;
- •Craniofacial syndromes;
- •Carious lesions;
- •History of previous orthodontic treatment.
结局指标
主要结局
Maxillary first molars width. Scale in millimeters and one decimal place.
时间窗: 6 months
Distance between centroid points of maxillary first molars
Maxillary first bicuspid width. Scale in millimeters and one decimal place.
时间窗: 6 months
Distance between centroid points of maxillary first bicuspids
Maxillary second bicuspid width. Scale in millimeters and one decimal place.
时间窗: 6 months
Distance between centroid points of maxillary second bicuspids
Maxillary first molas angulation. Scale in degrees and one decimal place.
时间窗: 6 months
Angulation formed, in occlusal view, by intersection of the lines resulted of the link between mesial-buccal cuspid tip and mesial-palatal cuspid tip of each molar.
Maxillary first bicuspids angulation. Scale in degrees and one decimal place.
时间窗: 6 months
Angulation formed, in occlusal view, by intersection of the lines resulted of the link between buccal cuspid tip and palatal cuspid tip of each bicuspid
Maxillary first molas inclination. Scale in degrees and one decimal place.
时间窗: 6 months
Angulation formed, in coronal view, by intersection of the lines resulted of the link between mesial-buccal cuspid tip and mesial-palatal cuspid tip of each molar
Maxillary first bicuspids inclination. Scale in degrees and one decimal place.
时间窗: 6 months
Angulation formed, in coronal view, by intersection of the lines resulted of the link between buccal cuspid tip and palatal cuspid tip of each bicuspid
次要结局
- Quality of life evaluation using questionnaires(2 weeks (2 times: 0 and 2 weeks after insert of device) and 6 months (after removal of device))
- Discomfort evaluation using questionnaires(24 hours (4 times: 0, 24, 48 and 72 hours after insert of device) and 1 week (2 times: 1 and 2 weeks after insert of device))
研究者
Dauro Douglas Oliveira
Associate professor and program director of Orthodontics
Pontifícia Universidade Católica de Minas Gerais