Impact of Different Dosages and Time of Administration of Metronidazole and Amoxicillin in the Treatment of Generalized Chronic Periodontitis: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 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 study was to compare the clinical and microbiological outcomes of different dosages of metronidazole (MTZ) and of the duration of the systemic administration of MTZ and amoxicillin as adjunct to scaling and root planing (SRP) in the treatment of generalized chronic periodontitis (GChP).
详细描述
Randomized clinical trials and systematic reviews have shown that the use of the combination of metronidazole (MTZ) and amoxicillin (AMX) significantly improves the benefits of the SRP in the treatment of subjects with periodontitis. However, the optimal dosage and interval of administration of these antibiotics are still unclear. Therefore, the aim of this study was to compare the clinical and microbiological outcomes of different dosages and duration of the systemic administration of the combination of MTZ and AMX as adjunct to scaling and root planing (SRP) in the treatment of generalized chronic periodontitis (GChP). One hundred ten subjects will be randomly assigned to receive SRP plus placebo, or SRP combined with 250 mg or 400 mg of MTZ, plus AMX (500 mg) TID, for either 7 or 14 days. Subjects will be clinically and microbiologically monitored up to 1 year post-therapy.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥30 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 12 months;
- •antibiotic therapy in the previous 6 months;
- •long-term intake of anti-inflammatory medications;
- •need for antibiotic pre-medication for routine dental therapy;
- •allergy to metronidazole and/or amoxicillin.
研究组 & 干预措施
Control
Scaling and root planing (SRP) + two placebo pills thrice a day (TID) for 14 days (control group)
干预措施: Scaling and root planing (SRP) (Procedure)
Control
Scaling and root planing (SRP) + two placebo pills thrice a day (TID) for 14 days (control group)
干预措施: Placebo 400 (14 days) (Other)
Control
Scaling and root planing (SRP) + two placebo pills thrice a day (TID) for 14 days (control group)
干预措施: Placebo 500 (Other)
MTZ 250 (7 days)
SRP + MTZ (250mg/TID) + AMX, for 7 days and placebos for another 7 days
干预措施: Scaling and root planing (SRP) (Procedure)
MTZ 250 (7 days)
SRP + MTZ (250mg/TID) + AMX, for 7 days and placebos for another 7 days
干预措施: Metronidazole 250 (7 days) (Drug)
MTZ 250 (7 days)
SRP + MTZ (250mg/TID) + AMX, for 7 days and placebos for another 7 days
干预措施: Amoxicillin (Drug)
MTZ 250 (7 days)
SRP + MTZ (250mg/TID) + AMX, for 7 days and placebos for another 7 days
干预措施: Placebo 250 (7 days) (Other)
MTZ 400 (7 days)
SRP + MTZ (400mg/TID) + AMX, for 7 days and placebos for another 7 days
干预措施: Scaling and root planing (SRP) (Procedure)
MTZ 400 (7 days)
SRP + MTZ (400mg/TID) + AMX, for 7 days and placebos for another 7 days
干预措施: Metronidazole 400 (7 days) (Drug)
MTZ 400 (7 days)
SRP + MTZ (400mg/TID) + AMX, for 7 days and placebos for another 7 days
干预措施: Amoxicillin (Drug)
MTZ 400 (7 days)
SRP + MTZ (400mg/TID) + AMX, for 7 days and placebos for another 7 days
干预措施: Placebo 400 (7 days) (Other)
MTZ 250 (14 days)
SRP +MTZ (250mg/TID) + AMX for 14 days
干预措施: Scaling and root planing (SRP) (Procedure)
MTZ 250 (14 days)
SRP +MTZ (250mg/TID) + AMX for 14 days
干预措施: Metronidazole 250 (14 days) (Drug)
MTZ 250 (14 days)
SRP +MTZ (250mg/TID) + AMX for 14 days
干预措施: Amoxicillin (Drug)
MTZ 400 (14 days)
SRP +MTZ (400mg/TID) + AMX for 14 days
干预措施: Scaling and root planing (SRP) (Procedure)
MTZ 400 (14 days)
SRP +MTZ (400mg/TID) + AMX for 14 days
干预措施: Metronidazole 400 (14 days) (Drug)
MTZ 400 (14 days)
SRP +MTZ (400mg/TID) + AMX for 14 days
干预措施: Amoxicillin (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
- 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)
- Number of sites with PD ≥ 7 mm(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)
- Reduction in the number of sites with PD ≥ 7 mm(Baseline, 3, 6 and 12 months)
- Full-mouth PD(Baseline, 3, 6 and 12 months)
- Full-mouth clinical attachment level(Baseline, 3, 6 and 12 months)
- Percentage of sites with bleeding on probing(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)
- Occurrence of headache obtained through a questionnaire of adverse effects(14 days after the beginning of treatments)
- Occurrence of vomiting obtained through a questionnaire of adverse effects(14 days after the beginning of treatments)
- Occurrence of diarrhea obtained through a questionnaire of adverse effects(14 days after the beginning of treatments)
- Occurrence of metallic taste obtained through a questionnaire of adverse effects(14 days after the beginning of treatments)
- Occurrence of nausea obtained through a questionnaire of adverse effects(14 days after the beginning of treatments)
- Occurrence of irritability obtained through a questionnaire of adverse effects(14 days after the beginning of treatments)
- Proportions of periodontal pathogenic bacterial species(Baseline, 3, 6 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