Antibiotic and Probiotic Therapies in the Adjuvant Treatment of the Chronic Periodontitis.
赞助:
Universidade Estadual Paulista Júlio de Mesquita Filho
合作者:
信息的提供 (责任方):
Maria Aparecida Neves Jardini，Universidade Estadual Paulista Júlio de Mesquita Filho
| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 6, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | May 2, 2018 | ||
| 预计主要完成日期 | May 3, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Probing Depth change[ Time Frame: 30, 90 and 180 days ] The change in the probing depth will be measure in millimeters before and after the treatment. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Antibiotic and Probiotic Therapies in the Adjuvant Treatment of the Chronic Periodontitis. | ||
| 正式标题 ICMJE | Effect of Antibiotic and Probiotic Therapies in the Adjuvant Treatment of Chronic Periodontitis: Randomized Controlled Clinical Trial. | ||
| 简要概况 | 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 chronic generalized periodontitis. |
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| 详细说明 | 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 chronic generalized periodontitis. Patients will be randomized into 3 groups: Group 1 (n=17): periodontal debridement, Group 2 (n=17): periodontal debridement associated with antibiotic (Metronidazole 400 mg + Amoxicillin 500mg) and Group 3 (n=17): 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 microbiological data obtained before and after periodontal therapy (baseline, 30, 90 and 180 days) 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. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Parallel Assignment Prospective double-blind randomized controlled clinical study with a 180-days follow-up. 盲法: Interventional 盲法描述: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. 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
51 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 1, 2019 | ||
| 预计主要完成日期 | May 3, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - 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 Exclusion Criteria: - 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. | ||
| 性别 |
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| 年龄 | 最小年龄：35 Years ，最大年龄：50 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Brazil | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Maria Aparecida Neves Jardini，Universidade Estadual Paulista Júlio de Mesquita Filho | ||
| 研究赞助商 ICMJE | Universidade Estadual Paulista Júlio de Mesquita Filho | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Universidade Estadual Paulista Júlio de Mesquita Filho | ||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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