Effects of Probiotic Ayran on Gingivitis

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06437925
• Other study ID #: Cukurova University-1
• Status: Completed
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: June 15, 2023

Study information

• Verified date: May 2024
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis
• Probiotics

Intervention

Dietary Supplement:
• probiotic ayran drink
The test group has received probiotic ayran drink for 6 weeks
• Placebo ayran drink
The control group has received placebo ayran drink for 6 weeks

Locations

Country	Name	City	State
Turkey	Cukurova University Faculty of Dentistry	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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