Adjunctive Effect of Erythritol on Pocket Closure Rates: RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Proportion of periodontal pockets with successful pocket closure
研究概览
简要总结
This clinical trial is studying whether using erythritol powder during non-surgical periodontal treatment (deep cleaning) helps improve gum health in people with severe periodontitis. Participants with deep gum pockets (4 mm or more) receive standard treatment alone or standard treatment plus cleaning with erythritol powder. The goal is to evaluate if adding erythritol improves outcomes such as healing of gum pockets, bleeding, plaque levels, and gum attachment compared to standard treatment alone.
详细描述
This study is testing whether erythritol powder, used during non-surgical periodontal treatment (also known as deep cleaning), can help improve gum health in people with advanced periodontitis (stage 3 or 4). Periodontitis is a serious gum infection that damages the soft tissue and bone supporting the teeth. Standard treatment includes removing plaque and tartar using manual tools or ultrasonic devices.
In this study, gum pockets that are 4 mm deep or more are treated either with standard care alone or with standard care plus a cleaning method that uses air pressure and erythritol powder (a sugar alcohol with antibacterial properties). The goal is to determine whether this additional step leads to improved clinical outcomes.
Participants are randomly assigned to one of the two treatments. The study tracks improvements in gum pocket depth after 2 and 4 months, as well as other indicators of periodontal health like bleeding and plaque levels. Researchers are also evaluating whether factors such as age, sex, smoking status, or diabetes influence treatment response.
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
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Diagnosed with stage 3 or 4 periodontitis according to the 2017 classification
- •Presence of at least 12 natural teeth
- •Presence of periodontal pockets with probing depth ≥ 4 mm in non-adjacent teeth
- •Good general health or stable systemic conditions (e.g., controlled diabetes)
排除标准
- •Use of antibiotics or anti-inflammatory drugs within 3 months prior to treatment
- •Periodontal treatment in the previous 6 months
- •Pregnancy or breastfeeding
- •Current smokers of more than 10 cigarettes per day
- •Allergies or intolerance to erythritol or any materials used in the treatment
- •Systemic diseases or conditions that could influence periodontal healing (e.g., uncontrolled diabetes, immunodeficiency)
- •Use of medications known to affect periodontal tissues (e.g., phenytoin, cyclosporine, calcium channel blockers)
结局指标
主要结局
Proportion of periodontal pockets with successful pocket closure
时间窗: 2 months and 4 months after treatment
Percentage of treated periodontal pockets (with baseline probing depth ≥ 4 mm) that reach pocket closure, defined as probing pocket depth ≤ 4 mm without bleeding on probing, or ≤ 3 mm, at follow-up.
次要结局
未报告次要终点
研究者
Davide Pietropaoli
DDS, PhD, Associate Professor of Dentistry (PI)
University of L'Aquila