Influence of Moment of Systemic Metronidazole and Amoxicillin Administration in the Treatment of Chronic Periodontitis: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months
研究概览
简要总结
The aim of this multicenter randomized clinical trial is to compare the clinical, microbiological and immunological effects of the adjunctive use of systemic metronidazole plus amoxicillin administered in different phases of the treatment of generalized chronic periodontitis.
详细描述
The combination of systemic metronidazole (MTZ) and amoxicillin (AMX) to scaling and root planing (SRP) has shown to be a promising periodontal treatment. However, some essential issues associated with the use of these antibiotics remain to be established. Although these agents are often prescribed after the healing phase of the SRP procedure, there is biological plausibility to support its use in conjunction with the mechanical treatment. However, to date, no placebo controlled randomized clinical trial (RCT) has directly compared these two protocols. Therefore, the aim of this multicentric RCT is to compare the clinical, microbiological and immunological effects of adjunctive systemic MTZ+AMX administered in different phases of the treatment of generalized chronic periodontitis (GChP). 180 subjects with GChP will be randomly assigned into three groups (n=60/group) that will receive SRP-only (control group) or in combination with 400 mg MTZ+500 mg AMX beginning at the first SRP session (group test 1) or after 3 months of its completion (group test 2). All volunteers will receive clinical and microbiological evaluation at baseline, 3, 6 and 12 months, and immunological assessment (levels of 20 chemokines) at baseline and 12 months post-therapy. Nine subgingival biofilm samples will be collected by subject and analyzed for counts and proportions of 40 bacterial species by checkerboard DNA-DNA hybridization. Differences in clinical, microbiological and immunological parameters among groups and over time will be evaluated using the ANOVA, ANCOVA, Chi-square and Tukey tests. Microbiological analyzes will be performed using adjustments for multiple comparisons. Statistical significance will be set at 5%.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥35 years of age;
- •at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction);
- •a minimum of 6 teeth with at least one site each with probing depth (PD) and clinical attachment level (CAL) ≥5 mm;
- •at least 30% of the sites with PD and CAL ≥4 mm and bleeding on probing (BOP).
排除标准
- •pregnancy;
- •breastfeeding;
- •current smoking and former smoking within the past 5 years;
- •systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis);
- •scaling and root planing an in the previous 6 months;
- •antibiotic therapy in the previous 6 months;
- •long-term intake of anti-inflammatory medications;
- •need for antibiotic pre-medication for routine dental therapy;
- •use of orthodontic appliances;
- •extensive dental prosthetic rehabilitation;
- •allergy to metronidazole and/or amoxicillin.
研究组 & 干预措施
Control
Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Placebos healing phase TID for 14 days.
干预措施: Scaling and root planing (Procedure)
Control
Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Placebos healing phase TID for 14 days.
干预措施: Placebos active phase (Drug)
Control
Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Placebos healing phase TID for 14 days.
干预措施: Placebos healing phase (Drug)
Active phase
Scaling and root planing + Metronidazole active phase (400 mg/thrice a day,TID) + Amoxicillin active phase (500 mg/ TID) for 14 days and Placebos healing phase TID for 14 days.
干预措施: Scaling and root planing (Procedure)
Active phase
Scaling and root planing + Metronidazole active phase (400 mg/thrice a day,TID) + Amoxicillin active phase (500 mg/ TID) for 14 days and Placebos healing phase TID for 14 days.
干预措施: Metronidazole active phase (Drug)
Active phase
Scaling and root planing + Metronidazole active phase (400 mg/thrice a day,TID) + Amoxicillin active phase (500 mg/ TID) for 14 days and Placebos healing phase TID for 14 days.
干预措施: Amoxicillin active phase (Drug)
Active phase
Scaling and root planing + Metronidazole active phase (400 mg/thrice a day,TID) + Amoxicillin active phase (500 mg/ TID) for 14 days and Placebos healing phase TID for 14 days.
干预措施: Placebos healing phase (Drug)
Healing phase
Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Metronidazole healing phase (400 mg/TID) + Amoxicillin healing phase (500 mg/TID) for 14 days.
干预措施: Scaling and root planing (Procedure)
Healing phase
Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Metronidazole healing phase (400 mg/TID) + Amoxicillin healing phase (500 mg/TID) for 14 days.
干预措施: Metronidazole healing phase (Drug)
Healing phase
Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Metronidazole healing phase (400 mg/TID) + Amoxicillin healing phase (500 mg/TID) for 14 days.
干预措施: Amoxicillin healing phase (Drug)
Healing phase
Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Metronidazole healing phase (400 mg/TID) + Amoxicillin healing phase (500 mg/TID) for 14 days.
干预措施: Placebos active phase (Drug)
结局指标
主要结局
Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months
时间窗: 12 months
次要结局
- Occurrence of nausea obtained through a questionnaire of adverse effects.(14 days after taking antibiotic.)
- Number of sites with PD ≥ 5 mm.(Baseline, 3, 6 and 12 months.)
- Number of sites with PD ≥ 6 mm.(Baseline, 3, 6 and 12 months.)
- Occurrence of headache obtained through a questionnaire of adverse effects.(14 days after taking antibiotic.)
- Proportions of periodontal pathogenic bacterial species.(Baseline, 3, 6 and 12 months.)
- Reduction in the number of sites with PD ≥ 5 mm.(Baseline, 3, 6 and 12 months.)
- Reduction in the number of sites with PD ≥ 6 mm.(Baseline, 3, 6 and 12 months.)
- Mean CAL changes in sites with initial CAL ≥ 7 mm.(Baseline - 12 months.)
- Full-mouth clinical attachment level.(Baseline, 3, 6 and 12 months.)
- Percentage of sites with plaque accumulation(Baseline, 3, 6 and 12 months.)
- Percentage of sites with marginal bleeding.(Baseline, 3, 6 and 12 months.)
- Number of sites with PD ≥ 7 mm.(Baseline, 3, 6 and 12 months.)
- Reduction in the number of sites with PD ≥ 7 mm.(Baseline, 3, 6 and 12 months.)
- Mean PD changes in sites with initial PD between 4-6 mm(Baseline - 12 months.)
- Mean PD changes in sites with initial PD ≥ 7 mm.(Baseline - 12 months.)
- Mean CAL changes in sites with initial CAL between 4-6 mm(Baseline - 12 months.)
- Full-mouth PD.(Baseline, 3, 6 and 12 months.)
- Percentage of sites with bleeding on probing.(Baseline, 3, 6 and 12 months.)
- Occurrence of vomiting obtained through a questionnaire of adverse effects.(14 days after taking antibiotic.)
- Occurrence of diarrhea obtained through a questionnaire of adverse effects.(14 days after taking antibiotic.)
- Occurrence of metallic taste obtained through a questionnaire of adverse effects.(14 days after taking antibiotic.)
- Occurrence of irritability obtained through a questionnaire of adverse effects.(14 days after taking antibiotic.)
- Counts of chemokines in the crevicular gingival fluid.(Baseline and 12 months.)
- Counts of periodontal pathogenic bacterial species.(Baseline, 3, 6 and 12 months.)
研究者
Belén Retamal-Valdes
DDS, MSc, PhD Student
University of Guarulhos