Modified Herbst Approach to Improve Chin Projection in Class II Malocclusion Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Lower incisor inclination
研究概览
简要总结
This study will collect data to try to assess which one of the two management options works better. The first option involves the use of the bite corrector first and then braces, while the second option involves the temporary addition of small support bone screws with the bite corrector later and then braces. Currently, it is not clearly known if there are important differences between the proposed management options. Such approaches are conventionally used in orthodontic practices. The information collected in this study will be used to compare the differences in the nature of the facial, teeth, and bone changes after the treatment. Questions about the experience while using the devices will be asked.
详细描述
Purpose
The present study will compare facial, skeletal, and dental changes among adolescents with mild to moderate Class II malocclusion using two Class II orthopedic orthodontic approaches. Patient-reported outcomes will also be assessed through validated questionnaires and qualitative interviews.
Hypothesis
Participants that use the modified Herbst approach do not showcase facial, dental, and skeletal changes that are different than those using the conventional Herbst approach.
Justification
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)
盲法说明
The patient and care provider can't be masked as it is obvious what appliance modification is being used.
入排标准
- 年龄范围
- 12 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Class II skeletal malocclusion based on PgOLp more than 85 mm and A-OLp more than 75 mm.
- •Perceived potential improvement of facial convexity.
- •At least end-to-end bilateral molar relationship.
- •Early permanent dentition.
- •No congenitally missing teeth.
- •Exclusion criteria:
- •Class II skeletal malocclusion based on PgOLp less than 85 mm and A-OLp less than 75 mm.
- •Only reasonable management option is surgery.
- •Less than an end-to-end bilateral molar relationship.
- •Mixed dentition dentition.
- •Congenitally missing teeth.
排除标准
- 未提供
结局指标
主要结局
Lower incisor inclination
时间窗: 1 year
Assess if the modified Herbst approach produces less incisor inclination than the conventional Herbst approach. The angulation in degrees between the lower incisor and the mandibular plane will be calculated.
Oral health-related quality of life
时间窗: 1 year
Assess if the oral health-related quality of life is different than the one with the conventional Herbst approach. The EuroQoL questionnaire will be used to assess oral health-related quality of life. The index calculates a value between 0 and 1. A higher value implies better QoL.
Skeletal chin prominence
时间窗: 1 year
Assess if the modified Herbst approach produces a more prominent chin protrusion than the one produced by the conventional Herbst. The distance in mm between the skeletal chin and a perpendicular virtual reference line will be calculated.
Overall quality of life
时间窗: 1 year
Assess if the overall quality of life is different than the one with the conventional Herbst approach. The CPQ11-14 ISF questionnaire will be used to assess oral health-related quality of life. The range of possible values es between 0 and 32. Lower values implied better perceived QoL.
Soft tissue Chin prominence
时间窗: 1 year
Assess if the modified Herbst approach produces a more prominent chin protrusion. The distance in mm between the lower lip and a perpendicular virtual reference line will be calculated
次要结局
- Mandibular lip prominence(1 year)
- Upper incisor inclination(1 year)
- Maxillary lip prominence(1 year)