Clinical Effects of Adjunctive Local Sodium Hypochlorite Gel in Minimally Invasive Non Surgical Debridement (MINSD) of Periodontal Pockets. A 6-month Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Probing depth changes
研究概览
简要总结
The aim of this study was to assess the efficacy of minimally invasive nonsurgical debridement (MINSD) of periodontal pockets with or without local amino acid buffered sodium hypochlorite (NaOCl) gel application after 6 months follow-up.
详细描述
Forty periodontal compromised patients were randomly allocated in two groups. Periodontal pockets > 5 mm in patients of test group were treated by MINSD and NaOCl gel application, meanwhile in patients of control group MINSD alone was performed. Full-mouth plaque score (FMPS) , Full-mouth bleeding score (FMBS), probing depth (PD), clinical attachment level (CAL) and gingival recession (GR) were assessed at baseline and after 6 months follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 32 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with periodontitis;
- •Age > 18 years old;
- •Patients with at least 10 teeth for arch;
- •Presence at least of two teeth with PD > 5 mm for quadrant;
- •Single-rooted and multi-rooted teeth;
排除标准
- •Patients with systemic diseases;
- •Pregnant or lactating;
- •Tobacco smokers (> 10 cigarettes/day);
- •Previous periodontal treatment in the last 2 years;
- •Prolonged antibiotic treatment or anti-inflammatory treatment within 6 months prior to periodontal therapy;
- •Furcation involvement;
- •Acute periodontal or endodontic abscess;
- •Third molars
研究组 & 干预措施
scaling and root planing, Sodium hypochlorite gel application
Periodontal pockets > 5 mm in patients of test group were treated by scaling and root planing and Sodium hypochlorite gel application
干预措施: Sodium hypochlorite gel application (Drug)
scaling and root planing alone
scaling and root planing alone was performed
干预措施: Sodium hypochlorite gel application (Drug)
结局指标
主要结局
Probing depth changes
时间窗: 6-months
Changes over time in probing depth millimiters
次要结局
未报告次要终点
研究者
Gaetano Isola, DDS, PhD
Researcher
University of Messina