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Completed

NCT Number: NCT06437925

Effects of Probiotic Ayran on Gingivitis

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).

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University Faculty of Dentistry

Adana, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

probiotic ayran drink

Dietary Supplement

The test group has received probiotic ayran drink for 6 weeks

Placebo ayran drink

Dietary Supplement

The control group has received placebo ayran drink for 6 weeks

Primary outcomes

  1. Plaque index

    Time frame: 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

  2. Gingival index

    Time frame: 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

  3. Bleeding on probing

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 31, 2024
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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