Clinical and Microbiological Effects of Adjunctive Metronidazole Plus Amoxicillin in the Treatment of Generalized Chronic Periodontitis: Smokers Versus Non-Smokers.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Mean clinical attachment level change post- scaling and root planing in sites with initial probing depth ≥ 7 mm
研究概览
简要总结
Randomized controlled clinical trials have demonstrated that the use of amoxicillin (AMX) and metronidazole (MTZ) as adjuncts to mechanical therapy improves the clinical and microbiological outcomes of scaling and root planing (SRP) in non-smokers and smokers with ChP. However, the effects of this antibiotic protocol have not been directly compared in non-smokers and smokers. Therefore, the aim of this study will be to compare the clinical and microbiological effects of the adjunctive use of MTZ+AMX to SRP in smokers and non-smokers subjects with chronic periodontitis (ChP). It was hypothesized that non-smokers would benefit better from this combination of therapies than the smokers.
详细描述
Sample size calculation:
This study is designed to compare the clinical and microbiological effects of the treatment of smoker and non-smoker subjects with SRP+MTZ+AMX. The ideal sample size to assure adequate power for this clinical trial was calculated considering differences of at least 1mm between groups for clinical attachment level (CAL) in initially deep periodontal sites (PD ≥ 7 mm). It was also determined that the standard deviation of CAL change at deep sites would be 1.0 mm based on our earlier studies of smokers and non-smokers receiving SRP combined with MTZ+AMX. Based on these calculations, it was defined that 26 subjects per group would be necessary to provide an 85% power with an α of 0.01. Considering an attrition of about 20%, it was established that at least 32 subjects should be included in each treatment group.
Experimental design and treatment protocol:
In this cohort clinical trial, subjects will be assigned according to their smoking status, into smoker and non-smoker groups. All subjects will receive SRP combined with systemic MTZ (400 mg) and AMX (500 mg). Both antibiotics will be administered T.I.D. for 14 days. Before the study begins, all subjects will receive full-mouth supragingival scaling and instruction on proper home-care techniques. They will receive the same dentifrice to use during the study period (Colgate Total). All subjects will receive full-mouth SRP performed under local anesthesia in four to six appointments lasting approximately 1h each. Treatment of the entire oral cavity will be done in 14 days. SRP will be performed by one trained periodontist using manual instruments. The antibiotic therapies will start immediately after the first session of mechanical instrumentation. The University Pharmacy will prepare the antibiotic pills and send them to the study coordinator, who will mark the code number of each subject on a set of two packs and give them to the examiner. All subjects will receive clinical and microbiological monitoring at baseline and at 3, 6 and 12 months post-therapy.
Clinical monitoring:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic periodontitis (AAP 1999);
- •≥35 years of age;
- •Presence of at least 15 teeth;
- •Minimum of 6 teeth with at least one site each with 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).
- •Smokers: had smoked at least 10 cigarettes per day for a minimum of 5 years;
- •Non-smokers: had never smoked.
排除标准
- •Previous subgingival periodontal therapy;
- •Pregnancy;
- •Systemic diseases that could affect the progression of periodontal disease (e.g. diabetes, osteoporosis);
- •Long-term administration of anti - inflammatory medications;
- •Need for antibiotic pre-medication for routine dental therapy;
- •Continuous use of mouthrinses containing antimicrobials;
- •Antibiotic therapy in the previous 6 months
- •Allergy to MTZ or AMX.
研究组 & 干预措施
Smoking
Metronidazole plus Amoxicillin
干预措施: Metronidazole plus Amoxicillin (Drug)
Non-Smoking
Metronidazole plus Amoxicillin
干预措施: Metronidazole plus Amoxicillin (Drug)
结局指标
主要结局
Mean clinical attachment level change post- scaling and root planing in sites with initial probing depth ≥ 7 mm
时间窗: At 3, 6 and 12 months post-therapy.
次要结局
- Number of subjects with low, moderate and high risk for disease progression.(At 3, 6 and 12 months post-therapy)
- Mean full-mouth clinical attachment level.(Baseline and at 3, 6 and 12 months post-therapy)
- Mean full-mouth probing depth.(Baseline and at 3, 6 and 12 months post-therapy.)
- Mean clinical attachment level change post-scaling and root planing in sites with initial probing depth between 4-6 mm(At 3, 6 and 12 months post-therapy)
- Mean probing depth reduction post-scaling and root planing in sites with initial probing depth between 4-6 mm(At 3, 6 and 12 months post-therapy.)
- Mean probing depth reduction post-scaling and root planing in sites with initial probing depth ≥ 7 mm(At 3, 6 and 12 months post-therapy.)
- Mean changes in levels of the 40 bacterial species evaluated by Checherboard DNA-DNA hybridization(At 3, 6 and 12 months post-therapy.)
- Mean changes in proportions of the 40 bacterial species evaluated by Checherboard DNA-DNA hybridization(At 3, 6 and 12 months post-therapy)
研究者
Marcelo Faveri
DDS, PhD.
University of Guarulhos