Comparison of Cleaning Efficacy of Different Cleaning Aids for Full-arch Implant Supported Fixed Protheses: A Self-controlled Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Plaque cleaning ratio
研究概览
简要总结
For patients with complete edentulism, full-arch implant-supported fixed prostheses can effectively restore functions such as mastication, esthetics, and speech. Their long-term clinical outcomes are predictable, and patient satisfaction is generally high. However, the probability of biological complications associated with full-arch implant-supported fixed prostheses within 10 years can be as high as 91.2%. Poor oral hygiene and plaque accumulation are important risk factors for these biological complications.
Proper cleaning and maintenance are crucial for the long-term success of full-arch implant-supported fixed prostheses. However, the most effective cleaning method remains unclear. Superfloss, interdental brushes, and water floss are commonly used auxiliary cleaning tools, but in vivo studies evaluating their cleaning efficacy are limited. Therefore, a randomized controlled study with a relatively long observation period is needed to better evaluate the cleaning effectiveness of different methods-superfloss, interdental brushes, and water floss-in patients with full-arch implant-supported fixed prostheses.
This study adopts a self-controlled, three-phase crossover design. Participants will sequentially use superfloss (S), interdental brushes (I), and a water flosser (W) to clean the surface of full-arch implant-supported fixed prostheses. Each cleaning method will be used for three months, after which a follow-up examination will be conducted. The participants will then switch to the second cleaning method, followed by another evaluation after three months. Finally, they will switch to the third cleaning method, and a final examination will be performed after an additional three months, completing the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •Age ≥18 years;
- •Patients with single-arch or full-arch edentulism / terminal dentition who have completed implant placement and immediate restoration and are scheduled to receive the definitive prosthesis;
- •Patients with good compliance who provide informed consent.
排除标准
- •Smoking (≥10 cigarettes per day);
- •Lack of self-care ability and unable to perform prosthesis cleaning independently;
- •Uncontrolled periodontitis in remaining teeth or unstable periodontal condition;
- •Presence of failed implants in the full-arch implant restoration and requiring second implantation.
研究组 & 干预措施
Superfloss
Using superfloss to clean the prosthesis
干预措施: Superfloss (Device)
Interdental brush
Using interdental brush to clean the prosthesis
干预措施: Interdental brush (Device)
Waterfloss
Using a water flosser to clean the prosthesis
干预措施: Waterfloss (Device)
结局指标
主要结局
Plaque cleaning ratio
时间窗: From enrollment to the end of every treatment at 12 weeks
area of the test surface (pixels)-area of residual artificial biofilm (pixels)/area of the test surface (pixels) \* 100 (%)
次要结局
未报告次要终点
研究者
Junyu Shi
Professor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
