Evaluation of Multiple Subgingival Irrigations With 10% Povidone Iodine After Scaling and Root Planing : a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of subjects reaching ≤ 4 mm in periodontal sites with PPD ≥ 5 mm
研究概览
简要总结
The study will be conducted at the Department of Periodontology, Cliniques universitaires Saint Luc. Patients diagnosed with Generalized Chronic Periodontitis (GChP) based on the current classification of the American Academy of Periodontology will be included. Detailed medical, periodontal and dental history will be obtained. Those who will fulfill the inclusion/exclusion criteria will be invited to participate in the study.
详细描述
The study will be conducted at the Department of Periodontology, Cliniques universitaires Saint Luc. The patients will be informed in detail of the nature and course of study, and will sign informed consent prior to engagement in the study. Patients diagnosed with GChP based on the current classification of the American Academy of Periodontology will be included. Detailed medical, periodontal and dental history will be obtained. Those who will fulfill the inclusion/exclusion criteria will be invited to participate in the study.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 30 years of age
- •At least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction)
- •Any history of periodontal treatment in the previous 6 months
- •No removable prosthesis
- •A minimum of 6 teeth with at least one site each with periodontal probing depth (PPD) and clinical attachment level (CAL) ≥5 mm
- •At least 30% of the sites with PPD and CAL ≥4 mm and bleeding on probing (BOP)
排除标准
- •Any sensitivity or allergy to any of the products that will be used in the study
- •Thyroid dysfunction
- •Systemic disease (ASA II or more)
- •Need for antibiotic pre-medication for routine dental therapy
- •Antibiotic therapy in the previous 3 months
- •Pregnancy and breastfeeding
- •Current smokers (more than 5 cigarettes a day)
研究组 & 干预措施
Povidone Iodine 10%
The side of the mouth receiving the subgingival irrigations of povidone iodine.
干预措施: Povidone-Iodine 10% (Drug)
Sterile saline solution
The other side of the mouth will be irrigated with a sterile saline solution.
干预措施: Saline Solution (Drug)
结局指标
主要结局
Percentage of subjects reaching ≤ 4 mm in periodontal sites with PPD ≥ 5 mm
时间窗: up to 6 months
The primary objective of this study is to determine the effect of PVI on periodontal probing depth (PPD).
次要结局
未报告次要终点