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临床试验/NCT07344805
NCT07344805已完成不适用

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

Cardenal Herrera University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年7月1日最近更新:
适应症
干预措施

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

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

Active Comparator

干预措施: Cavitron® ultrasonic scaler (Device)

Periodontal maintenance with erythritol air polishing

Experimental

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

发起方
Cardenal Herrera University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chirag Sheth

Associate Professor

Cardenal Herrera University

研究点 (1)

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