Clinical Effects and Metagenomic Analysis of Using an Air Polishing Device With Erythritol Powder Compared to Scaling and Root Planing in Periodontal Maintenance Therapy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement of clinical periodontal parameter: clinical attachment level
研究概览
简要总结
Periodontitis is a chronic, multifactorial disease primarily driven by the accumulation of bacterial deposits. Treatment involves the mechanical removal of the biofilm, traditionally performed by scaling and root planing (SRP). However, SRP is time-consuming and can cause irreversible damage to both hard and soft tissues as well as postoperative sensitivity. Consequently, adjunctive or alternative air-polishing devices have been developed. The objective of this study is to compare the clinical and microbiological efficacy of an erythritol-powder air-polishing device versus SRP in periodontal maintenance therapy.To evaluate patient-reported pain and treatment time for erythritol air-polishing versus SRP. A randomized clinical trial was designed and participants were randomly assigned to one of two groups: Intervention: Perio-Flow® (air + erythritol powder) and PIEZON PS®. Control: Ultrasonic debridement followed by SRP with Gracey curettes.At baseline and at six months, probing depth, clinical attachment level, and bleeding on probing were recorded. Saliva samples were collected to detect the most prevalent periodontal pathogens. Patient discomfort during treatment was measured by a visual analog scale, and procedure duration was timed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have received basic periodontal treatment between 3-6 months before the study.
排除标准
- •Pregnant or breastfeeding patients.
- •Use of systemic antibiotics within 6 months prior to the study.
- •Patients who smoke more than 10 cigarettes/day.
- •Uncontrolled diabetic patients.
研究组 & 干预措施
Periodontal maintenance with ultrasonic + scaling and root planning
干预措施: Cavitron® ultrasonic scaler (Device)
Periodontal maintenance with erythritol air polishing
干预措施: AIRFLOW® Prophylaxis Master (Device)
结局指标
主要结局
Improvement of clinical periodontal parameter: clinical attachment level
时间窗: six months
Measurement of clinical attachment level in milimeters
Improvement of clinical periodontal parameter: probing depth
时间窗: six months
Measurement of probing depth in milimeters
Improvement of clinical periodontal parameter: bleeding index
时间窗: six months
Measurement of bleeding index in percentage.
次要结局
- Changes in periodontal microbiome(Six months)
研究者
Chirag Sheth
Associate Professor
Cardenal Herrera University
