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临床试验/NCT01888666
NCT01888666已完成不适用

Comparison Between Rapid and Slow Palatal Expansion: Evaluation of Periodontal Indices

University of L'Aquila1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
evaluation of periodontal health by probing pocket depth, PPD

研究概览

简要总结

The aim of this study is to evaluate the periodontal effects during rapid palatal expansion (RPE) or slow palatal expansion (SPE) and to compare them by means of periodontal indices, in order to establish the possible differences and advantages of one of these treatments in periodontal terms.

Materials and methods: 10 patients will selected and submitted to RPE treatment; other 10 patients will selected and submitted to SPE treatment. The patients will treated with the Haas appliance. In both the groups the periodontal clinical indices (plaque index, PI; papillary bleeding index, PBI; probing pocket depth, PPD) will collected three times during the treatment (before, during and at the end). All measurements will performed by the same examiner.

A descriptive statistical analysis will conducted. The paired samples Student's T test will used to evaluate the intra-group differences between t1 and t2. The unpaired samples Student's T test will used to evaluate between groups differences at t1 and t2. The significance level will set at 95%.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • palate narrow
  • necessity of performing a expansion treatment

排除标准

  • dental disease

结局指标

主要结局

evaluation of periodontal health by probing pocket depth, PPD

时间窗: Change from Baseline in probing pocket depth at 20 days and 5 months of active therapy

In the Group I (RPE), probing pocket depth were detected in three stages: T0, detected 7 days after the periodontal prophylaxis (at the beginning of the active orthodontic therapy) ; T1, detected after 20 days of active therapy; T2, detected after 5 months of retention therapy. In the Group II, the collected data corresponded to: T0, detected 7 days after the periodontal prophylaxis; T1, detected during clinical control after 3 months of active therapy; T2, detected after 3 months of restraint. All measurements were performed by the same examiner.

次要结局

  • valuation of periodontal health by plaque index, PI(Change from Baseline in plaque index at 20 days and 5 months of active therapy)
  • evaluation of periodontal health by papillary bleeding index, PBI(Change from Baseline in papillary bleeding index at 20 days and 5 months of active therapy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Enrico Marchetti

Contract professor

University of L'Aquila

研究点 (1)

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