Clinical trial NCT06437925: Effects of Probiotic Ayran on Gingivitis
Official title: Effects of the Use of Probiotics Ayran on Gingival Inflammation: An Experimental Gingivitis Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Probiotics
Inflamed Gums
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plaque index
timeFrame: Plaque index will be recorded at baseline, at day 42 and 47
measure: Gingival index
timeFrame: Gingival index will be recorded at baseline, at day 42 and 47
measure: Bleeding on probing
timeFrame: BOP will be recorded at baseline, at day 42 and 47
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Faculty of Dentistry
Study officials:
affiliation: Professor Doctor
name: Cenk Haytac, phd
role: PRINCIPAL_INVESTIGATOR
References: