The Response of Periodontal Pathogens to the Respective or Combined Treatment of Scaling and Root Planning and Locally Delivered Minocycline in Patients With Chronic Periodontitis- a Short-term Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 主要终点
- Pocket Depth
研究概览
简要总结
To evaluate the respective or combinatory efficacy of locally delivered 2% Minocycline (MO) and surface and root planning (SRP) by assessing both clinical parameters and the loads of four main periodontal pathogens in treating chronic periodontitis.
详细描述
In this randomized clinical trial, the investigators will evaluate the respective or combinatory efficacy of minocycline and scaling and root planning in the aspects of both clinical parameters [Pocket depth (PD) and sulcus bleeding index (SBI)] and the loads of four main periodontal pathogens [Aggregatibacter actinomycetemcomitans (Aa), Fusobacterium nucleatum (Fn), Porphyromonas gingivalis (Pg) and Prevotella intermedia (Pi)]. Real-time quantitative PCR (qRT-PCR) will be used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria in a period of 7 days. The investigators will also try to correlate the reduction of either total or respective bacteria with the improvements of clinical parameters, with an aim to uncovering the potential microbiological mechanism accounting for the efficacy of a therapy.
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 (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with moderate or severe chronic periodontal disease, and exhibited bleeding on probing and attachment loss, with radiographic alveolar bone loss in four or more teeth
排除标准
- •pregnant, had used antibiotics within the last 3 months, had periodontal therapy in the past 6 months or had systemic diseases such as heart disease or hypertension
研究组 & 干预措施
surface and root planning
surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)
干预措施: surface and root planning (Procedure)
locally delivered minocycline
Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth
干预措施: minocycline (Drug)
locally delivered minocycline
Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth
干预措施: surface and root planning (Procedure)
surface and root planning+minocycline
surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.
干预措施: minocycline (Drug)
结局指标
主要结局
Pocket Depth
时间窗: 7 days
PD is measured using a standard CPI（community periodontal index） probe (Shanghai Medical Instruments, Shanghai, China) and assessed to the nearest millimeter.
次要结局
- Bleeding on Probing(7 days)
- Bacterial Load(7 days)
研究者
Shuli Deng
Dr.
Zhejiang University