Timing of Administration of Systemic Antibiotics Associated With Scaling and Root Planing in the Treatment of Periodontitis: Clinical and Microbiological Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm.
研究概览
简要总结
This randomized clinical trial aimed to compare the clinical and microbiological effects of different times of administration of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of periodontitis.
详细描述
Scaling and root planing (SRP) is the most used periodontal therapy for periodontal treatment. Despite leading, in most cases, to an improvement in periodontal clinical parameters, SRP is often insufficient to profoundly modify the pathogenic bacterial profile to a profile related to periodontal health, especially in cases of more advanced and generalized diseases. Thus, other therapies supporting SRP, such as systemic antibiotics, have been proposed with the aim of enhancing the clinical and microbiological effects of this form of therapy. Studies have shown excellent clinical and microbiological results using the association of systemic antibiotics, especially the association of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of severe periodontitis. However, some essential issues associated with the use of these antibiotics remain to be established. Therefore, the aim of this randomized clinical trial was to compare the clinical and microbiological effects of different times of administration of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of periodontitis. Seventy-two subjects with severe periodontitis were selected and randomized into two groups (n = 36 / group) - Test 1 (T1): SRP in 14 days, associated with the concomitant use of AMX (500mg, 3x / day) and MTZ (400mg 3x / day) for 14 days; and Test 2 (T2): SRP in 14 days, associated with the use of AMX and MTZ immediately after the end of the SRP in the following 14 days. All volunteers received clinical and microbiological evaluation at baseline, 3, 6 and 12 months post-SRP. Subgingival biofilm samples were collected by subject and analyzed for counts and proportions of 40 bacterial species by checkerboard DNA-DNA hybridization. Differences in clinical and microbiological parameters between groups and over time were evaluated using the ANOVA, ANCOVA, Chi-square and Tukey tests. Microbiological analyzes were performed using adjustments for multiple comparisons. Statistical significance was 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 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 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
Test 1
Scaling and root planing + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) for 14 days, starting with the first SRP session
干预措施: Scaling and root planing (Procedure)
Test 1
Scaling and root planing + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) for 14 days, starting with the first SRP session
干预措施: Placebos after SRP (Drug)
Test 1
Scaling and root planing + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) for 14 days, starting with the first SRP session
干预措施: Metronidazole during SRP (Drug)
Test 1
Scaling and root planing + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) for 14 days, starting with the first SRP session
干预措施: Amoxicillin during SRP (Drug)
Test 2
Scaling and root planing (SRP) + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) immediately after the end of the SRP in the following 14 days.
干预措施: Scaling and root planing (Procedure)
Test 2
Scaling and root planing (SRP) + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) immediately after the end of the SRP in the following 14 days.
干预措施: Placebos during SRP (Drug)
Test 2
Scaling and root planing (SRP) + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) immediately after the end of the SRP in the following 14 days.
干预措施: Metronidazole after SRP (Drug)
Test 2
Scaling and root planing (SRP) + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) immediately after the end of the SRP in the following 14 days.
干预措施: Amoxicillin after SRP (Drug)
结局指标
主要结局
Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm.
时间窗: 12 months
次要结局
- 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.)
- Mean CAL changes in sites with initial CAL between 4-6 mm ,(Baseline - 12 months.)
- Occurrence of metallic taste obtained through a questionnaire of adverse effects.(14 days after taking antibiotic.)
- Occurrence of nausea obtained through a questionnaire of adverse effects.(14 days after taking antibiotic.)
- Reduction in the number of sites with PD ≥ 5 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 clinical attachment level.(Baseline, 3, 6 and 12 months.)
- Occurrence of diarrhea obtained through a questionnaire of adverse effects.(14 days after taking antibiotic.)
- 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.)
- Percentage of sites with marginal bleeding.(Baseline, 3, 6 and 12 months.)
- 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.)
- 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.)
- Full-mouth PD.(Baseline, 3, 6 and 12 months.)
- Occurrence of headache obtained through a questionnaire of adverse effects.(14 days after taking antibiotic.)
- Occurrence of vomiting 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.)
- 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
Professor
University of Guarulhos