Evaluation of PLGA Microspheres Loaded With Doxycycline Associated to Periodontal Debridement in the Treatment of Chronic Advanced Periodontitis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Probing depht (PD)
研究概览
简要总结
The aim of this clinical study is to asses the effect of ultrasonic periodontal debridement associated to locally delivered doxycycline (20%) by PLGA microspheres on chronic generalized periodontitis treatment.
详细描述
Thirty patients with chronic periodontitis and a minimum of seven pockets (>5
mm) in non-molars teeth that bled on probing will be selected. Patients will be randomly
assigned to ultrasonic periodontal debridement followed by local application of doxycycline
by PLGA microspheres (DB+DOX) and periodontal debridement followed by administration
of void PLGA microspheres (DB). Plaque, bleeding on probe, clinical attachment level
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic generalized periodontitis (AAP,1999);
- •At least 7 sites with probing depths >5mm, and 2 sites with probing depth >7mm;
- •At least 20 teeth present;
- •Systemically healthy.
排除标准
- •Had received periodontal care 6 months prior to the study;
- •Had taken medications known to interfere with periodontal health and healing 6 months prior to the study;
- •Pregnants or lactants;
- •Sensitive to doxycycline.
研究组 & 干预措施
Test group: DB+DOX
Test group: DB (full mouth debridment) +DOX (doxicicline) - 45 minutes of full-mouth debridement + subgingival application of PLGA microspheres loading doxycycline 10%.
干预措施: Doxicicline (Drug)
Test group: DB+DOX
Test group: DB (full mouth debridment) +DOX (doxicicline) - 45 minutes of full-mouth debridement + subgingival application of PLGA microspheres loading doxycycline 10%.
干预措施: Full-mouth debridment (Procedure)
Control group: DB alone
Control group: DB alone (Full-mouth debridment)
Intervention: 45 minutes of full-mouth debridement + subgingival application of void PLGA microspheres.
干预措施: Full-mouth debridment (Procedure)
结局指标
主要结局
Probing depht (PD)
时间窗: 6 months
Probing depth (PD) will be measured at six sites per tooth by a PCP-15 periodontal Probe (Hu-Friedy - Chicago, IL, USA); This measure will be performed with the use of a plastic stent, presenting edges for the positioning of the stent probe.
次要结局
- Clinical attachment level (CAL)(6 months)
研究者
Enilson Antonio Sallum
Professor, department of Periodontics, Piracicaba Dental School, State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil
University of Campinas, Brazil