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Adjunctive Probiotics in Chronic Periodontitis

2019年3月10日 更新者:Sana Ikram, MPhil Trainee、Ziauddin Hospital

Effect of Probiotic Along With Scaling and Root Planing in the Treatment of Chronic Periodontitis

This study will assess clinical and microbiological efficacy of probiotics and antibiotics in patients of chronic periodontitis as an adjunctive to scaling and root planing (SRP) in reducing bacterial count and in improving clinical periodontal parameters over the period of 12 weeks.Also the comparison between these adjunctives will be made for clinical assessment clinical periodontal parameters will be taken .these parameters plaque index (PI), gingival index (GI), clinical attachment loss (CAL) and pocket probing depth (PPD) for microbiological assessment plaque sample will be taken, DNA will be extracted and then sample will be processed through quantitative polymerase chain reaction (qPCR) for quantitative analysis of bacterial count of porphyromonas gingivalis.

研究概览

详细说明

In this clinical trial total 60 participants of clinically diagnosed chronic periodontitis will be recruited after taking a written consent for their approval. Participants will be divided into 3 groups A, B and C through the process of randomization using a method of opaque sealed envelopes. A research assistant will be hired for the purpose of randomization and allocation concealment. All participants will be asked to pick an opaque envelope containing the details of treatment products. After randomization plaque sample will be obtained from the depth of periodontal pockets and all the clinical periodontal parameters will be recorded in every participant. Then all the participants will undergo SRP. After SRP group A will be given antibiotics Amoxicillin 500 milligrams (mg) for 3 times a day (TDS) and Metronidazole 400 milligrams (mg) for twice a day (BD) for 5 days. Group B will be given probiotics lactobacillus reuteri 1.2 billion colony forming unit (CFU) sachets twice daily for swallowing with water for 12 weeks. Group C will be given lactobacillus sachets of same amount and participant will be asked to mix it with little amount of water and apply it on teeth with the toothbrush twice daily after brushing with standard tooth paste for 12 weeks. Patients will be recalled at the interval of 3, 6, 9 and 12 weeks for the recording of clinical periodontal parameters. After completion of trial plaque sample will be taken again from every participant and will be processed through qPCR to check bacterial count of porphyromonas gingivalis before and after treatment. Whereas comparison between clinical periodontal parameters will be made at the interval of 0, 3, 6, 9, 12 weeks.

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Sindh
      • Karachi、Sindh、巴基斯坦、75600
        • Ziauddin Dental College

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients with clinically diagnosed chronic periodontitis with a pocket depth of ≥4mm.
  • Patients with age ≥30 years.

Exclusion Criteria:

  • Handicapped patients who are physically or mentally unable to maintain their oral hygiene.
  • Pregnant and lactating females.
  • Patients with habits of smoking, chewing tobacco and alcohol consumption.
  • Patients on local or systemic antibiotic treatment.
  • Patients with any systemic diseases.
  • Patients with the history of any periodontal therapy within last 6 months.
  • Patients undergoing orthodontic treatment.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:Local Probiotics
P Flor (Lactobacillus reuteri 1.2 billion CFU) will be delivered locally every 12 hours for 12 weeks
Locally delivered Lactobacillus reuteri 1.2 CFU per gram
实验性的:Systemic Probiotics
P Flor (Lactobacillus reuteri 1.2 billion CFU) will be administered every 12 hours for 12 weeks
Systemically administered Lactobacillus reuteri 1.2 CFU per gram
有源比较器:Systemic Antibiotics
Amoxil 500 mg capsule and Flagyl 400 mg tablet by mouth, will be given every 8 hours for 5 days
Systemically administered Amoxil 500 mg thrice daily
Systemically administered Metronidazole 400 mg twice daily

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in periodontal pocket depth (PPD)
大体时间:Baseline, 3, 6, 9 and 12 weeks
It is the distance from tip of free gingival margin to the base of pocket
Baseline, 3, 6, 9 and 12 weeks
Change in clinical attachment level (CAL)
大体时间:Baseline, 3, 6, 9 and 12 weeks
It is the distance from cementoenamel junction to the base of the pocket around the tooth
Baseline, 3, 6, 9 and 12 weeks
Change in bacterial load of Porphyromonas gingivalis
大体时间:Baseline and 12 weeks after completion of trial
Bacterial count or the quantity of porphyromonas gingivalis in the sample
Baseline and 12 weeks after completion of trial

次要结果测量

结果测量
措施说明
大体时间
Change in the Plaque index (PI)
大体时间:Baseline, 3, 6, 9 and 12 weeks
How much surface of tooth is covered by the plaque will be recorded.
Baseline, 3, 6, 9 and 12 weeks
Change in Gingival index (GI)
大体时间:Baseline, 3, 6, 9 and 12 weeks
Gingival color texture and inflammation will be recorded.
Baseline, 3, 6, 9 and 12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年11月1日

初级完成 (实际的)

2018年9月1日

研究完成 (实际的)

2018年10月1日

研究注册日期

首次提交

2018年4月3日

首先提交符合 QC 标准的

2018年4月13日

首次发布 (实际的)

2018年4月17日

研究记录更新

最后更新发布 (实际的)

2019年3月12日

上次提交的符合 QC 标准的更新

2019年3月10日

最后验证

2019年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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