3D Comparison of Anterior Teeth Retraction and Anchorage Control Between En-masse and Two-step Mechanics: A Randomized Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Anchorage loss
研究概览
简要总结
The aim of this study is to compare en masse (EM) and two-step anterior teeth retraction (TSR) evaluated by means of three-dimensional images superimposition. Thirty-two adult patients with bimaxillary protrusion planed for treatment with four first premolar extractions will be enrolled. All patients will be randomly allocated in a 1:1 ratio to either EM (n=16) group or the TSR (n=16) group. Cone bean computed tomography will be taken before and after anterior retraction. A blind observer will construct separate 3D models for maxillary and mandibular surfaces using the anterior cranial fossa to register models of before and after space closing. Quantitative assessment of posterior anchorage loss and amount of anterior teeth retraction are the main outcomes. The secondary outcomes are the inclination of the molars, canines and incisors.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Angle Class I malocclusion;
- •Bimaxillary protrusion;
- •Convex profile;
- •All natural teeth present in the mouth;
- •Absence of crowding or with negative discrepancy up to 4mm;
- •Absence of vertical and transverse occlusal problems;
- •Good oral health;
- •Good general health.
排除标准
- •Lack of time to attend consultations;
- •Patients with severe systemic and psychological illness;
- •Patients with parafunction (bruxism), reflux or eating disorders;
- •Presence of periodontal disease;
研究组 & 干预措施
En Masse Retraction
Group treated by retracting the six anterior teeth simultaneously.
干预措施: En masse anterior teeth retraction (Procedure)
Two-Step Retraction
Group treated by retracting the canines incisors in two different steps.
干预措施: Two-Step Retraction (Procedure)
结局指标
主要结局
Anchorage loss
时间窗: 12 months
Quantitative assessment of posterior anchorage loss between the two groups as measured by tomographic superimposition at the end of space closure.
Anterior teeth retraction
时间窗: 12 months
Quantitative assessment of anterior teeth retraction between the two groups as measured by tomographic superimposition at the end of space closure.
次要结局
- Molar inclination(12 months)
- Canine inclination(12 months)
- Incisors inclination(12 months)
研究者
Sergio Roberto de Oliveira Caetano
Masters in Orthodontics, PhD Student
Rio de Janeiro State University