Treatment of Unilateral Posterior Cross Bite in the Mixed Dentition; a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Skeletal expansion at the level of the palatal median suture - the change fram Baseline
研究概览
简要总结
Rapid maxillary expansion and quad-helix are two well established appliances in dentistry used for posterior cross bite treatment. This study aims to compare this two different appliances in patients in their early mixed dentition, regarding treatment effects of the extra oral soft tissue but also dental and skeletal effects, if the children experience any pain and discomfort during treatment and the study also aims to make a cost minimization analysis. Comparison of these different treatments are barely made and no randomized controlled trial is yet published. No study has evaluated the difference of subjective experience during these two treatments. After this study we will know which one of these two appliances are the most effective, regarding cost minimization and treatment result but we are also able to put it in relation to the patients subjective experience
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
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children in the early mixed dentition
- •Unilateral posterior cross bite including the first permanent molar
排除标准
- •No ongoing sucking habits
- •Craniofacial syndroms
- •Earlier Orthodontic treatments
- •Not able to independently understand and answer the questionnaires
结局指标
主要结局
Skeletal expansion at the level of the palatal median suture - the change fram Baseline
时间窗: At baseline, directly after expansion and one year after expansion
Skeletal expansion evaluated by computed tomography at three time points in both arms. The change in width of the palatal median suture is going to be evaluated and compared to the Baseline values, in both arms.
The change of inclination of teeth and alveolar bone and side effects between the time points
时间窗: At baseline, directly after expansion and one year after expansion
Dental effects and side effects evaluated by computed tomography at three time points in both arms.The change in degree of angulation and inclination of the dental structures (e.g. tooth inclinations) is going to be evaluated and compared to the Baseline values, in both arms.
次要结局
- Assessment of the soft tissue changes(At baseline, directly after expansion, six months and one year after expansion)
- Cost-effectiveness of two treatment modalities in treatment of posterior cross bite(Through study completion, an average of 18 months)
- Evaluation of pain and discomfort(Three times during the first week after inserting the appliances)
- Evaluation of Temporomandibular Disorder (TMD)(Baseline and one year after expansion)