跳至主要内容
临床试验/NCT05211219
NCT05211219已完成不适用

The Role of Probiotics in Preventing Dysbiosis in Periodontal Disease

Gazi University4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
4
主要终点
Periodontal probing depth

研究概览

简要总结

In this randomized controlled trial, it was aimed to evaluate the effect of probiotics (chewable tablets) and kefir consumption in the initial periodontal treatment of periodontitis patients on the change of oral microbiota and treatment. In this clinical trial, 36 systemically healthy volunteers who were diagnosed with periodontitis who were admitted to Gazi University Faculty of Dentistry, Department of Periodontology were included. Besides the inclusion criteria, the nutritional habits of the patients were evaluated by questionnaire. For diagnosis, plaque index, gingival index, bleeding on probing, periodontal probing depth and clinical attachment level were examined. Patients were randomly divided into 3 groups; probiotic, kefir and control group. Following the periodontal diagnosis, clinical index records of the patients and subgingival microbial samples were obtained. The supragingival plaque sample was removed and the subgingival microbial dental plaque sample was gently taken with a sterile Gracey curette. In the same session, periodontal initial treatment was started. According to the groups, they were involved simultaneously with the treatment, kefir group was advised to consume kefir as a liquid once a day in 14 days; probiotics group was advised to consume as a chewable tablet once a day in 14 days; the control group was advised without additional food supplements. Periodontal indexes were repeated in the 1st and 3rd months. Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia (T. forsythia), Porphyromonas gingivalis (P. gingivalis), and Treponema denticola (T. denticola).

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
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy
  • Individuals over 18
  • Periodontitis (4-6 mm pockets) patients with 3 teeth in each half of the jaws except wisdom tooth
  • Not using probiotic tablets/capsules and consuming no more than 3-4 probiotic food.

排除标准

  • Antibiotic use within 6 months.
  • Breastfeeding or pregnancy.
  • Acute oral lesions or necrotizing ulcerative periodontitis
  • Diabetes, rheumatic fever, lung, kidney disease history and drug use that will affect periodontal tissues
  • Patients who smoke or who did not stop until last year
  • Use of probiotics tablets or capsules
  • Probiotic food consumption not more than 3-4 times a week

结局指标

主要结局

Periodontal probing depth

时间窗: 3rd month

the distance from the gingival margin to pocket base.

Gingival index

时间窗: 3rd month

It is an index that shows the severity and quantity of gingival inflammation.

Microbiological sample

时间窗: 3rd month

Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia, Porphyromonas gingivalis, and Treponema denticola.

Bleeding on probing

时间窗: 3rd month

Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.

Plaque index

时间窗: 3rd month

It is an index that shows the amount of microbial dental plaque on the teeth.

次要结局

  • Clinical attachment level(3rd month)

研究者

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

Nurdan Ozmeric

Professor

Gazi University

研究点 (4)

Loading locations...

相似试验