Effects of Probiotic Ayran on Gingivitis

NCT06437925 | Completed

• 1 other identifier: Cukurova University-1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Gingivitis; Probiotics; Inflamed Gums

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Dietary Supplement: probiotic ayran drink

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.

Dietary Supplement: Placebo ayran drink

Interventions

probiotic ayran drink DIETARY_SUPPLEMENT

The test group has received probiotic ayran drink for 6 weeks

Probiotic ayran drink

Placebo ayran drink DIETARY_SUPPLEMENT

The control group has received placebo ayran drink for 6 weeks

Placebo ayran drink

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University Faculty of Dentistry

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Cenk Haytac, phd

  Professor Doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 31, 2024
• Study Start: January 15, 2023
• Primary Completion: April 15, 2023
• Study Completion: June 15, 2023
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data is ready and can be shared for two years
• Access Criteria: The data will be shared upon request

Locations

TU (1)