Local Effect of Periodontal Debridement Associated With Different Systemic Antibiotic Protocols and Single or Repeated Application of Photodynamic Therapy to Treat Generalized Aggressive Periodontitis: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in Probing Depth (PD)
研究概览
简要总结
The aim of this project is to compare the efficacy and the local effect of the association of single or repeated application of photodynamic therapy (PDT) with antibiotic agents using Amoxicillin + Metronidazole or Clarithromycin in the treatment of patients with Generalized Aggressive Periodontitis (GAgP).
详细描述
The study methodology is according to CONSORT-STATEMENT 2010 and SPIRIT 2013 for randomized controlled clinical trials.
Study Design
The study is designed as a prospective, interventional, parallel, blinded, randomized, controlled clinical trial aimed to compare the efficacy and the local effect of the association of single or repeated application of photodynamic therapy (PDT) with antibiotic agents using Amoxicillin + Metronidazole or Clarithromycin in the treatment of patients with Generalized Aggressive Periodontitis (GAgP).
Source of data
The population of this study will be recruited among patients referred to the Science and Technology Institute (ICT) - São José dos Campos, College of Dentistry. Each one of 46 patients will have three pockets with probing depth and loss of clinical attachment level ≥5 mm and bleeding on probing not located at furcation sites randomly chosen.
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
- 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 GAgP (Armitage, 1999; American Academy of Periodontology, 2015);
- •presence of ≥20 teeth, excluding third molars and teeth indicated for extraction;
- •presence of ≥6 sites presenting PD ≥5 mm with bleeding on probing and ≥2 sites with PD ≥7 mm (including incisors and first molars, in addition to two other non-contiguous teeth between them);
- •presence of three non-adjacent periodontal pockets with probing depth ≥5 mm and bleeding on probing not located in furcation area;
- •good general health (ASA I/II);
- •18-35 years old;
- •agree to participate in the study and sign a written consent (Resolution # 196 of October 1996 and the Brazilian Professional Code of Dental Ethics - 179/93).
排除标准
- •pregnant or nursing;
- •suffer from any systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc - ASA III/IV/V);
- •antimicrobials or anti-inflammatory drugs in the previous 6 months;
- •periodontal treatment within the last 12 months;
- •smoke ≥10 cigarettes/day;
- •reported allergy to amoxicillin, metronidazole or clarithromycin;
- •required antibiotic prophylaxis;
- •current use of any medication that could interfere with periodontal response were excluded from the study.
研究组 & 干预措施
PD + (AMX + MET)
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg
干预措施: Full-mouth ultrasonic debridement (Procedure)
PD + (AMX + MET)
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg
干预措施: Amoxicillin 500mg (Drug)
PD + (AMX + MET)
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg
干预措施: Metronidazole 400mg (Drug)
PD + CLM
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic clarithromycin 500 mg
干预措施: Full-mouth ultrasonic debridement (Procedure)
PD + CLM
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic clarithromycin 500 mg
干预措施: Clarithromycin 500mg (Drug)
PD + (AMX + MET) + sPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg and single application of PDT
干预措施: Full-mouth ultrasonic debridement (Procedure)
PD + (AMX + MET) + sPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg and single application of PDT
干预措施: Amoxicillin 500mg (Drug)
PD + (AMX + MET) + sPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg and single application of PDT
干预措施: Metronidazole 400mg (Drug)
PD + (AMX + MET) + sPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg and single application of PDT
干预措施: Single application of PDT (Procedure)
PD + CLM + sPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Clarithromycin 500 mg and single application of PDT
干预措施: Full-mouth ultrasonic debridement (Procedure)
PD + CLM + sPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Clarithromycin 500 mg and single application of PDT
干预措施: Clarithromycin 500mg (Drug)
PD + CLM + sPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Clarithromycin 500 mg and single application of PDT
干预措施: Single application of PDT (Procedure)
PD + (AMX + MET) + rPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg and repeated application of PDT
干预措施: Full-mouth ultrasonic debridement (Procedure)
PD + (AMX + MET) + rPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg and repeated application of PDT
干预措施: Amoxicillin 500mg (Drug)
PD + (AMX + MET) + rPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg and repeated application of PDT
干预措施: Metronidazole 400mg (Drug)
PD + (AMX + MET) + rPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg and repeated application of PDT
干预措施: Repeated application of PDT (Procedure)
PD + CLM + rPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Clarithromycin 500 mg and repeated application of PDT
干预措施: Full-mouth ultrasonic debridement (Procedure)
PD + CLM + rPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Clarithromycin 500 mg and repeated application of PDT
干预措施: Clarithromycin 500mg (Drug)
PD + CLM + rPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Clarithromycin 500 mg and repeated application of PDT
干预措施: Repeated application of PDT (Procedure)
结局指标
主要结局
Change in Probing Depth (PD)
时间窗: 0, 3 and 6 post-operatively
Evaluate the difference between baseline and 6 months PD measures.
次要结局
未报告次要终点
研究者
Mauro Pedrine Santamaria
PhD Adjunct professor
Universidade Estadual Paulista Júlio de Mesquita Filho