Effect of Antibiotic and Probiotic Therapies in the Adjuvant Treatment of Chronic Periodontitis: Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Probing Depth change
研究概览
简要总结
Currently, with the increase of bacterial resistance to antibiotics associated with its side effects, it is necessary to find other adjuncts to combat the disease that are an alternative to the use of antibiotics. The use of probiotics has been proposed in the literature as an adjunct therapy for the treatment of periodontal diseases, however, few controlled and randomized clinical studies have been performed. The objective of this double-blind randomized controlled trial will be to evaluate the response of clinical and microbiological periodontal parameters to the comparison of two different adjuvant therapies (antibiotic and probiotic) for the treatment of stages II and III grade B periodontitis.
详细描述
Currently, with the increase of bacterial resistance to antibiotics associated with its side effects, it is necessary to find other adjuncts to combat the disease that are an alternative to the use of antibiotics. The use of probiotics has been proposed in the literature as an adjunct therapy for the treatment of periodontal diseases, however, few controlled and randomized clinical studies have been performed. The objective of this double-blind randomized controlled trial will be to evaluate the response of clinical and immunological periodontal parameters to the comparison of two different adjuvant therapies (antibiotic and probiotic) for the treatment of stages II and III grade B periodontitis. Patients will be randomized into 3 groups: Group 1 (n=15): periodontal debridement, Group 2 (n=15): periodontal debridement associated with antibiotic (Metronidazole 400 mg + Amoxicillin 500mg) and Group 3 (n=15): periodontal debridement associated with probiotic (Lactobacillus reuteri). Clinical (plaque index, gingival index, probing depth, gingival recession, relative clinical attachment level and periodontal inflamed surface area (PISA) index) and immunological data obtained before and after periodontal therapy (baseline, 30 and 90) will be consolidated and made available on average ± standard deviation and normality tested using the Shapiro-Wilk test. For statistical analysis, the software BioEstat 5.0 (Belém, PA, Brazil) will be used, with p-value < 0,05.
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 (Care Provider, Investigator, Outcomes Assessor)
盲法说明
In addition to concealment of randomization, the investigator responsible for the procedures of periodontal therapy (periodontal debridement) and the researcher responsible for the measurements will not know which treatment each group will receive, characterizing the blindness of the study.
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals between 35 and 50 years of age;
- •Be diagnosed with generalized chronic periodontitis: present a loss of interproximal clinical insertion> 3 mm in 2 nonadjacent teeth and loss of interproximal clinical insertion ≥5 mm, in 30% or more of the teeth present;
- •Present at least 16 teeth;
- •Present good systemic health;
- •Agree to participate in the study and sign the informed consent form
排除标准
- •Patients with systemic problems (cardiovascular changes, blood dyscrasias, immunodeficiency, among others), which do not indicate the periodontal procedure;
- •Have undergone periodontal treatment in the last twelve months;
- •Have used antibiotics and/or anti-inflammatories for the past six months;
- •Smoking patients;
- •Pregnancy or Lactation;
- •Chronic use of medications that may alter the response of periodontal tissues.
研究组 & 干预措施
placebo
Periodontal debridement treatment will be performed in a single session after the therapy will be administered the Placebo Oral Tablet twice a day for 21 days.
干预措施: Placebo Oral Tablet (Drug)
Metronidazole and Amoxicillin
Periodontal debridement treatment in a single session Metronidazole 400mg + Amoxicillin 500mg every 8 hours for 7 days.
干预措施: Amoxicillin 500 Mg (Drug)
Lactobacillus reuteri
Periodontal debridement treatment in a single session Lactobacillus reuteri Oral Drops twice a day for 21 days.
干预措施: Lactobacillus reuteri Oral Drops (Drug)
结局指标
主要结局
Probing Depth change
时间窗: Baseline, 30 and 90 days
The change in the probing depth will be measure in millimeters before and after the treatment.
次要结局
- Gingival Recession(Baseline, 30 and 90 days)
- Clinical Attachment Level(Baseline, 30 and 90 days)
- Periodontal Inflamed Surface Area (PISA)(Baseline, 30 and 90 days)
- Microbiological Parameters(Baseline, 30 and 90 days)
- Plaque Index(Baseline, 30 and 90 days)
- Gingival Index(Baseline, 30 and 90 days)
研究者
Maria Aparecida Neves Jardini
Professor
Universidade Estadual Paulista Júlio de Mesquita Filho