Full-mouth Periodontal Debridement Associated With Two Different Antibiotic Agents 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 Clinical Attachment Level (CAL)
研究概览
简要总结
The aim of this study is to assess the clinical outcomes of full-mouth ultrasonic debridement combined with clarithromycin or amoxicillin + metronidazole association for the treatment of generalized aggressive periodontitis (GAgP).
详细描述
The study methodology is according to CONSORT-STATEMENT 2010 for randomized controlled clinical trials.
Study Design
The study is designed as a prospective, interventional, parallel, triple blind, randomized, controlled clinical trial aimed to assess the clinical outcomes of full-mouth ultrasonic debridement combined with clarithromycin or amoxicillin + metronidazole association for the treatment of generalized aggressive periodontitis (GAgP). The study was approved by Institute of Science and Technology's (ICT - State University of São Paulo) Ethics Committee (protocol 1.079.307).
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. Patients will fill a healthy history questionnaire to ensure that they are medically qualified for participate in this study. Based on the power calculation for this study, 44 subjects divided into two groups will be needed to achieve 80% power to detect a 0.8 mm difference in the clinical attachment level (CAL) of patients.
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
- Triple (Participant, 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 GAgP (AAP, 1999);
- •presence of ≥20 teeth;
- •presence of ≥ 6 sites presenting PD ≥ 5mm with bleeding on probing (BOP) and ≥2 sites with PD ≥7mm (including incisors and first molars, in addition to other two non-contiguous teeth);
- •good general health;
- •≤ 35 years old; and
- •agree to participate in the study and sign a written informed consent. All subjects will be individually informed about the objectives, probable risks and benefits of the protocol treatment (according to Resolution nº196 of October 1996 and to the Professional Code of Dental Ethics - 179/93).
排除标准
- •pregnancy or lactating;
- •suffer from any systemic disease (e.g. cardiovascular disorders, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease;
- •took antimicrobials in the previous 6 months;
- •taking long-term anti-inflammatory drugs;
- •previous periodontal treatment within the last 12 months;
研究组 & 干预措施
Amoxicillin and Metronidazole
In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
干预措施: Full-mouth ultrasonic debridement (Procedure)
Amoxicillin and Metronidazole
In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
干预措施: Amoxicillin (Drug)
Amoxicillin and Metronidazole
In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
干预措施: Metronidazole (Drug)
Clarithromycin
In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
干预措施: Full-mouth ultrasonic debridement (Procedure)
Clarithromycin
In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
干预措施: Clarithromycin (Drug)
结局指标
主要结局
Change in Clinical Attachment Level (CAL)
时间窗: Baseline, 3 and 6 months
Evaluate the difference between baseline and 6 months CAL measures.
次要结局
- Change in Probing Depth (PB)(Baseline, 3 and 6 months)
- Change in Bleeding on Probe (BoP)(Baseline, 3 and 6 months)
研究者
Mauro Pedrine Santamaria
Professor
Universidade Estadual Paulista Júlio de Mesquita Filho