Comparison Between Surgical Access and Repeated Applications of APDT to Residual Pockets Treatment in Generalized Aggressive Periodontitis: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 主要终点
- Clinical attachment level
研究概览
简要总结
The aim of this study will be to compare the approach of repeated applications of APDT versus surgical therapy for the treatment of residual pockets in generalized agressive periodontitis.
详细描述
Scaling and root planing may be insufficient to resolve the periodontal infection resulting in residual periodontal pockets. A method of treatment to these sites would be the surgical therapy, because it allows access to root surfaces, making possible a better decontamination. However, the surgical approach may bring some negative points, as more discomfort and postoperative morbidity, increased transoperatory risk and increased risk of contamination. Thus, finding other alternatives to residual pockets treatment, antimicrobial photodynamic therapy (aPDT) was recently proposed. Therefore, the aim of this study will be to compare the approach of repeated applications of APDT versus surgical therapy for the treatment of residual pockets in generalized agressive periodontitis.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of generalized aggressive periodontitis (Armitage, 1999; American Academy of Periodontology, 2015);
- •Have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement);
- •Present at least one residual pocket of probing depth ≥ 5 mm and bleeding on probe not located in furcation region;
- •Good general health;
- •Agree to participate in the study and sign the informed consent form (TCLE) after explaining the risks and benefits;
排除标准
- •Systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - ASA III / IV / V) that contraindicate the periodontal procedure;
- •Have used antibiotics and anti-inflammatories in the last six months;
- •Smoke ≥ 10 cigarettes/day;
- •Pregnant or lactating;
- •Chronic use of medications that may alter the response of periodontal tissues;
- •Indication of antibiotic prophylaxis for dental procedures;
研究组 & 干预措施
Open flap debridement
In this group (n = 22), patients will receive open flap debridement will be performed to treat residual pockets.
干预措施: Open flap debridement (Procedure)
Repeated application of aPDT
In this group (n=22), patients will receive 5 applications of antimicrobial photodynamic therapy after the scaling and root planing.
干预措施: Repeated application of aPDT (Procedure)
结局指标
主要结局
Clinical attachment level
时间窗: 6 months
次要结局
- Probing depth(6 months)
研究者
Mauro Pedrine Santamaria
DDS,MS,PhD
Universidade Estadual Paulista Júlio de Mesquita Filho