Effects of Probiotic Ayran on Gingivitis

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

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).

Study Overview

• Status: Completed
• Conditions: Gingivitis; Probiotics; Inflamed Gums
• Intervention / Treatment: Dietary supplement: probiotic ayran drink; Dietary supplement: Placebo ayran drink

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey
    • Cukurova university Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic ayran drink; 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.	Dietary supplement: probiotic ayran drink; The test group has received probiotic ayran drink for 6 weeks
Placebo Comparator: Placebo ayran drink; 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.	Dietary supplement: Placebo ayran drink; The control group has received placebo ayran drink for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index	PI was scored from 0 to 5 according to the color change obtained with the Mira-2 solution	Plaque index will be recorded at baseline, at day 42 and 47
Gingival index	GI is graded by visual assessment and mechanical stimulation of the gingival tissues, scoring the gingival condition according to the criteria	Gingival index will be recorded at baseline, at day 42 and 47
Bleeding on probing	The probing bleeding (BOP) index was determined by the presence/absence of bleeding ≈30 seconds after probing	BOP will be recorded at baseline, at day 42 and 47

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Principal Investigator: Cenk Haytac, phd, PROFESSOR DOCTOR

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: Cukurova University-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be shared upon request
• IPD Sharing Time Frame: The data is ready and can be shared for two years
• IPD Sharing Access Criteria: The data will be shared upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No