Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure
Gingival Margin Stability After Mucogingival Plastic Surgery. The Effect of Manual Versus Powered Toothbrushing: a Randomized Clinical Trial
研究概览
详细说明
BACKGROUND Oscillating-rotating power toothbrushes have been proven clinically efficacious. To the investigators' knowledge, a clinical evaluation of the safety of these toothbrushes after surgical root coverage procedure have not been published. The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes.
METHODS Sixty healthy patients with at least a single Miller Class I or II gingival recession underwent surgical root coverage procedure. Soft-bristle manual and powered toothbrushes were given to participants randomly assigned to control and test group, respectively. Full-mouth plaque score, Full-mouth Bleeding Score, Probing Pocket Depth and Recession Depth were recorded 1, 3 and 6 months after completion of surgical procedure. Longitudinal analyses were performed using linear random-intercept models to take into account within-subject correlations over time. Temporal trend differences across treatments by including treatment-time interaction terms were then tested using a global Wald test.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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MI
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Milan、MI、意大利、20122
- Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Full-Mouth Plaque Score (FMPS) ≤25%
- Full-Mouth Bleeding Score (FMBS) ≤25%
- Miller Class I and II buccal recession ≥2 mm
Exclusion Criteria:
- Relevant systemic condition or disease
- Smokers
- Teeth with prosthetic crowns or restorations in the cervical area
- Presence of pulling frenum in the keratinized tissue
- Previous mucogingival or periodontal surgery in the experimental site
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Manual Toothbrush
Patients were instructed in the Roll Brushing Technique, twice daily for 2 min.
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Gum Delicate Post-Surgical Toothbrush, Oral-B, Procter & Gamble, Cincinnati, OH
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实验性的：Oscillating-rotating toothbrush
Patients received manufacturer's instructions for use, including brushing twice daily for 2 min.
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Triumph 5000, Oral-B, Procter & Gamble, Cincinnati, OH
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Complete Root Coverage Rate
大体时间：Change in Complete Root Coverage Rate at 1 month
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Abscence of exposed root surface measured ad percentage
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Change in Complete Root Coverage Rate at 1 month
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Change in Complete Root Coverage Rate
大体时间：Change in Complete Root Coverage Rate at 3 months
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Abscence of exposed root surface measured ad percentage
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Change in Complete Root Coverage Rate at 3 months
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Change in Complete Root Coverage Rate
大体时间：Change in Complete Root Coverage Rate at 6 months
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Abscence of exposed root surface measured ad percentage
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Change in Complete Root Coverage Rate at 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Recession Depth
大体时间：Baseline, 1 month, 3 months, 6 months
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Distance from the gingival margin to the cementum-enamel junction, measured in millimeters
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Baseline, 1 month, 3 months, 6 months
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Change in Clinical Attachment Level
大体时间：Baseline, 1 month, 3 months, 6 months
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Distance from the cementum-enamel junction to the bottom of the periodontal Pocket, measured in millimeters
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Baseline, 1 month, 3 months, 6 months
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Change in Probing Pocket Depth
大体时间：Baseline, 1 month, 3 months, 6 months
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Distance from the gingival margin to the bottom of the periodontal pocket, measured in millimeters
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Baseline, 1 month, 3 months, 6 months
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合作者和调查者
调查人员
- 研究主任：Giulio Rasperini、Unit of Periodontology, Department of Biomedical, Surgical and Dental Sciences, University of Milan, Foundation IRCCS Ca' Granda Policlinic
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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