Non-surgical Periodontal Therapy: Efficacy of Repeated Subgingival Instrumentation for Non-responding Sites. A Quasi-experimental Study
试验速览
- 阶段
- 不适用
- 入组人数
- 63
- 主要终点
- Number of pocket closures
研究概览
简要总结
The current experimental protocol is a pre-post quasi-experimental design. A cohort of individuals will be enrolled progressively according to a screening record of periodontitis. They were treated with PMPR and Subgingival Instrumentation according to their diagnosis. After 3 months they will be re-evaluated, and non-responding sites (Ppd>=4mm and bop+) will be scheduled for the second session of PMPR and SI. After 2 months they will be re-evaluated and clinical efficacy will be defined.
详细描述
The current experimental protocol is a pre-post quasi-experimental design. A cohort of individuals will be enrolled progressively according to a screening record of periodontitis. Once included, individuals will receive, by a calibrated examiner, a full-mouth periodontal chart, and accordingly, they will be treated in a multi-step approach, in accordance with the recent clinical guidelines. The treatment will consist of oral hygiene instruction and motivation, risk factor control, professional mechanical plaque removal (PMPR), and subgingival instrumentation (SI): it will be performed by two experienced operators. Thereafter, after 3 months, patients will be evaluated and a new periodontal chart will be performed. The presence of non-responding sites (Ppd>4 and bop+) will be treated with the second session of PMPR plus Subgingival Instrumentation. After 2 months patients will be clinically evaluated and a full periodontal chart will be completed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unremarkable general health; age 18-80; minimum of 20 teeth; Periodontitis (Stage 1-4); no antibiotic intake in the previous 6 months;
排除标准
- •Subgingival instrumentation in the previous 12 months
- •No antibiotic intake in the previous 3 months
- •A compromised medical condition requiring prophylactic antibiotic coverage
- •Pregnant/nursing
- •Ongoing drug therapy that might alter the clinical signs and symptoms of periodontitis
结局指标
主要结局
Number of pocket closures
时间窗: through study completition, 6 months
Proportion of pathological periodontal pockets (non responding site) that will be closed (Ppd \<5 and bop-) after the second instrumentation
次要结局
未报告次要终点
研究者
Nicola Discepoli
Associate Professor
University of Siena