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临床试验/NCT06437925
NCT06437925已完成不适用

Effects of the Use of Probiotics Ayran on Gingival Inflammation: An Experimental Gingivitis Study

Cukurova University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Plaque index

研究概览

简要总结

Objectives: This study investigates the effects of daily consumption of probiotic ayran drink on gingival inflammation and the development of experimental gingivitis.

Methods: A total of 54volunteer students were included in the present randomized, double-blind, placebo-controlled trial.The participants were divided randomly into two groups; The Control group consisted of 27 participants who consumed placebo ayran, while the 27 participants of the Test group consumed probiotic ayran (containing Lactobacillus acidophilus and Bifidobacterium bifidum) for 42 days twice a day.After 42 days, mechanical plaque control was interrupted for 5 days. The clinical parameters of gingivitis; Plaque index (PI), gingival index (GI), probing bleeding (BOP), probing depth (PPD) were recorded at baseline, day 42 (beginning of experimental gingivitis) and day 47 (the end of experimental gingivitis). At the same time points, gingival crevicular fluid had been collected for analysis of matrix metalloproteinase - 8 (MMP-8).

详细描述

The most used and studied probiotics in the periodontal literature are lactobacillus and bifidobacterium. The current study aims to observe the effects of daily ayran consumption containing a probiotic combination of Lactobacillus acidophilus and Bifidobacterium bifidum on plaque development and gingival inflammation in an experimental gingivitis model of healthy individuals. The null hypothesis of this study using of probiotics has no additional benefit for periodontal health.

This study evaluates the effects of daily consumption of ayran containing a probiotic combination of Lactobacillus Acidophilus and Bifidobacterium Bifidum on plaque development and gingival status in healthy individuals with experimental gingivitis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Systemic healthy
  • •Subjects with gingivitis defined as a BOP sites ≥ 10% and PD ≤ 3 mm
  • •No radiographic bone loss
  • •Non-smoking participants

排除标准

  • •History of using antibiotics or anti-inflammatory drugs or probiotic preparations or food supplements in the last 6 months,
  • •Undergoing orthodontic treatment,
  • •Active carious lesions
  • •Mouth breathing
  • •History of allergy for milk or fermented milk products.
  • •Taking medications affecting the gingiva and/or oral mucosa

研究组 & 干预措施

Probiotic ayran drink

Experimental

The participants in this experimental group will use probiotic containing ayran for 42 days and then will be subjected to 5 days of experimental gingivitis.

干预措施: probiotic ayran drink (Dietary Supplement)

Placebo ayran drink

Placebo Comparator

The participants in this control group will use control ayran without probiotics for 42 days and then will be subjected to 5 days of experimental gingivitis.

干预措施: Placebo ayran drink (Dietary Supplement)

结局指标

主要结局

Plaque index

时间窗: Plaque index will be recorded at baseline, at day 42 and 47

PI was scored from 0 to 5 according to the color change obtained with the Mira-2 solution

Gingival index

时间窗: Gingival index will be recorded at baseline, at day 42 and 47

GI is graded by visual assessment and mechanical stimulation of the gingival tissues, scoring the gingival condition according to the criteria

Bleeding on probing

时间窗: BOP will be recorded at baseline, at day 42 and 47

The probing bleeding (BOP) index was determined by the presence/absence of bleeding ≈30 seconds after probing

次要结局

未报告次要终点

研究者

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

Cenk Haytac

Professor

Cukurova University

研究点 (1)

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