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临床试验/NCT04209777
NCT04209777已完成3 期

Clinical Evaluation of Smoker Periodontal Subjects After Lactobacillus-reuteri Probiotics and Antibiotics Therapy With Scaling and Root Debridement: a Clinical Trial

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2018年7月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
66
试验地点
1
主要终点
Change in Clinical attachment level

研究概览

简要总结

It is a clinical trial conducted on smokers with chronic periodontitis in which the participants are divided into two groups and one group is provided with antibiotics while the other with probiotics as an adjunct to non-surgical therapy. The participants were assessed for change in probing pocket depths, attachment loss, bleeding on probing, plaque index and gingival index after 1-month and 3-month period.

详细描述

Background:

Periodontal disease is a chronic inflammatory disease of the supporting structures of the tooth which includes periodontal ligament, cementum, and bone. Conventional periodontal therapy involves a non-surgical and surgical method for mechanical debridement of supragingival and subgingival sites to eliminate the pathogens and reduce inflammation of the periodontium. Smokers respond less to conventional therapy and require antibiotics for additional benefits. Where the use of antibiotics provides benefits to the host, the increasing proportion of developing antibiotic resistance are a major concern. The introduction of "Probiotics" as a treatment option is under special consideration. According to WHO, Probiotics are defined as viable micro-organisms which when delivered in an appropriate dose, provides health benefits. Lactobacillus-reuteri has been considered as a reliable option in regards to safety with no reported adverse effects, in the treatment of periodontitis as an adjunct to Scaling and Root Debridement.

Objectives:

The objective of the present study is to evaluate the clinical improvement of Lactobacillusreuteri Probiotics in comparison to a combination of amoxicillin and metronidazole antibiotics in smokers with moderate to severe chronic periodontitis after non-surgical scaling and root debridement.

Method:

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 (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • systemically healthy males or females.
  • at least 35 years of age with minimal 3 natural teeth in each quadrant excluding 3rd molar.
  • previously untreated moderate to severe generalized chronic periodontitis
  • were current smokers having ≥10 cigarettes /day.

排除标准

  • having periodontal therapy within the past 6 months.
  • have undergone antibiotics or long-term NSAIDS therapy within the past 6 months.
  • have an allergy to penicillin and metronidazole.
  • having either fixed or removable prosthesis.
  • pregnant or nursing females.

研究组 & 干预措施

Antibiotics

Active Comparator

The antibiotic group is provided with amoxicillin capsules 500mg and metronidazole tablets 400mg three times a day for 7 days along with the placebo of probiotics twice daily for 30 days.

干预措施: Antibiotics (Drug)

Probiotics

Experimental

The probiotic group is provided with Lactobacillus-reuteri probiotics (2x10(8)CFU) twice daily after brushing for 30 days.

干预措施: Probiotic Blend Chewable Tablet (Drug)

结局指标

主要结局

Change in Clinical attachment level

时间窗: After 3-months.

Clinical attachment level is recorded on six sites per tooth.

Change in Bleeding on probing

时间窗: After 3-months.

Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.

Change in Probing pocket depth

时间窗: After 3-months.

Probing pocket depth is recorded on six sites per tooth.

次要结局

  • Change in Plaque index(After 3-months.)
  • Change in Gingival index(After 3-months.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehwish Ghazal

Principal investigator

Dow University of Health Sciences

研究点 (1)

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