Interceptive Study of Ectopic Eruption of Permanent Maxillary Canine Teeth
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in permant canine tooth position measured by Sector and Alpha angle
研究概览
简要总结
The purpose of this study is to see whether extraction of the primary canine tooth or extraction of both the primary canine - and the primary first molar tooth is most effective in the treatment of palatally ectopic canine teeth in the maxilla. In addition the study will also measure pain and discomfort in relation to these two treatment alternatives.
详细描述
Study objectives:
- Evaluate the effectiveness of concomitant extraction of the maxillary deciduous canine and maxillary deciduous first molar as compared to extraction of the deciduous maxillary canine only as an interceptive measure for improving the eruption path of ectopic maxillary canines.
- Evaluate whether there is a difference in the use of analgesics, pain and discomfort between the two treatment groups in 1.
Procedure:
After informed consent patients will randomly be assigned to one of two groups. Group1: Extraction of the deciduous canine only Group 2: Extraction of both the deciduous canine and the deciduous first molar
Randomization The block randomization method will be used. Block sizes will randomly vary from 2, 4, 6 and 8. Blocks will be generated from free software at http://www.randomization.com . Allocation concealment is done by enclosing assignments into sequentially numbered envelopes. Envelopes that will have to be torn to open will be used. The randomization process will be done by a staff member at TkNN that is not involved in the trial.
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
- None
入排标准
- 年龄范围
- 9 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •mixed dentition with both primary maxillary canine and primary maxillary first molars present
- •palatally ectopic canines present. (palatally ectopic canines will be diagnosed via measurements developed by Ericson and Kurol using DPT images. A canine with and alpha angle of ≥ 25 degrees in sectors 2 through 5, and palatal position observed on intraoral radiographs
排除标准
- •previous orthodontic treatment
- •any disease not allowing local anesthesia or extraction
- •craniofacial syndromes, cleft lip palate
- •odontomas, cysts
研究组 & 干预措施
Primary canine and primary molar teeth
Extraction of primary canine and primary first molar teeth
干预措施: Tooth extraction (Procedure)
Primary canine tooth
Extraction of primary canine tooth
干预措施: Tooth extraction (Procedure)
结局指标
主要结局
Change in permant canine tooth position measured by Sector and Alpha angle
时间窗: 12 months
Change in Sector and Alpha angle measured on panoramic radiographs will be reported
次要结局
- Pain and discomfort after tooth extraction reported by questionnaire(1 week after tooth extraction)