Combined Application of Er:YAG Laser and Sub-gingival Air Polishing Powder in Treatment of Periodontitis: A Split-mouth, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in PD
研究概览
简要总结
Periodontitis (gum disease) is an infection of the gums that can lead to tooth loss. In recent years, many types of dental lasers or other devices have been used for the non-surgical treatment of periodontal diseases. However, it remains unclear whether the combined application of laser and air polishing is effective as an adjuvant treatment for periodontitis. The purpose of this study is to compare the use of combined application of Er:YAG laser and sub-gingival air polishing powder, with the treatment of Er:YAG laser only, in periodontal diseases treatment in a Chinese population.
详细描述
The study will use a split-mouth design, two quadrants (one quadrant from each jaw) were randomly allocated to either the test or control group. The quadrants in the test group received Er:YAG laser (ERL) plus sub-gingival air polishing treatment, while the quadrants in the control group received ERL only. Clinical periodontal examinations were evaluated at baseline, 3 months, 6 months, 1 year, and 2 years.
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1) aged 35-65 years old, in good systemic healthy;
- •2) clinically diagnosed with generalized stage Ⅱ or stage Ⅲ periodontitis;
- •3) a minimum of 20 teeth
排除标准
- •1) pregnancy or recent pregnancy plans;
- •2) had received periodontal treatment within the previous 6 months;
- •3) taken antibiotics within the previous 3 months;
- •4) had diabetes;
- •5) obvious malocclusion, history of orthodontic treatment, or a habit of mouth breathing.
结局指标
主要结局
Changes in PD
时间窗: at 3 months, 6 months, 1 year, and 2 years
Changes in probing depth (PD) measured using periodontal probing
Changes in CAL
时间窗: at 3 months, 6 months, 1 year, and 2 years
Changes in clinical attachment level (CAL) measured using periodontal probing
次要结局
- changes in BI(at 3 months, 6 months, 1 year, and 2 years)
- PLI(at 3 months, 6 months, 1 year, and 2 years)