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Clinical Trials/NCT06437925
NCT06437925CompletedNot Applicable

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

Cukurova University2 sites in 2 countries54 target enrollmentStarted: January 15, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
54
Locations
2
Primary Endpoint
Plaque index

Study Overview

Brief Summary

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).

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cenk Haytac

Professor

Cukurova University

Study Sites (2)

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