Gingival Margin Stability After Mucogingival Plastic Surgery. The Effect of Manual Versus Powered Toothbrushing: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Complete Root Coverage Rate
研究概览
简要总结
The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full-Mouth Plaque Score (FMPS) ≤25%
- •Full-Mouth Bleeding Score (FMBS) ≤25%
- •Miller Class I and II buccal recession ≥2 mm
排除标准
- •Relevant systemic condition or disease
- •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
研究组 & 干预措施
Manual Toothbrush
Patients were instructed in the Roll Brushing Technique, twice daily for 2 min.
干预措施: Manual Toothbrush (Device)
Oscillating-rotating toothbrush
Patients received manufacturer's instructions for use, including brushing twice daily for 2 min.
干预措施: Oscillating-rotating toothbrush (Device)
结局指标
主要结局
Change in Complete Root Coverage Rate
时间窗: Change in Complete Root Coverage Rate at 6 months
Abscence of exposed root surface measured ad percentage
Change in Complete Root Coverage Rate
时间窗: Change in Complete Root Coverage Rate at 1 month
Abscence of exposed root surface measured ad percentage
Change in Complete Root Coverage Rate
时间窗: Change in Complete Root Coverage Rate at 3 months
Abscence of exposed root surface measured ad percentage
次要结局
- Change in Recession Depth(Baseline, 1 month, 3 months, 6 months)
- Change in Clinical Attachment Level(Baseline, 1 month, 3 months, 6 months)
- Change in Probing Pocket Depth(Baseline, 1 month, 3 months, 6 months)
研究者
Giulio Rasperini
Prof.
University of Milan