## Protocol Section
### Identification Module
**NCT ID:** NCT06437925

**Brief Title:** Effects of Probiotic Ayran on Gingivitis

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

#### Organization Study ID Info
**ID:** Cukurova University-1
#### Organization
**Class:** OTHER
**Full Name:** Cukurova University
### Status Module
#### Completion Date
**Date:** 2023-06-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-04-15

**Type:** ACTUAL

#### Start Date
**Date:** 2023-01-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cukurova University

#### Responsible Party

**Investigator Affiliation:** Cukurova University

**Investigator Full Name:** Cenk Haytac

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Gingivitis

- Probiotics

- Inflamed Gums

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 54

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Dietary Supplement: probiotic ayran drink

**Label:** Probiotic ayran drink

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Dietary Supplement: Placebo ayran drink

**Label:** Placebo ayran drink

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Probiotic ayran drink

**Description:** The test group has received probiotic ayran drink for 6 weeks

**Name:** probiotic ayran drink

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Placebo ayran drink

**Description:** The control group has received placebo ayran drink for 6 weeks

**Name:** Placebo ayran drink

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** PI was scored from 0 to 5 according to the color change obtained with the Mira-2 solution

**Measure:** Plaque index

**Time Frame:** Plaque index will be recorded at baseline, at day 42 and 47

**Description:** GI is graded by visual assessment and mechanical stimulation of the gingival tissues, scoring the gingival condition according to the criteria

**Measure:** Gingival index

**Time Frame:** Gingival index will be recorded at baseline, at day 42 and 47

**Description:** The probing bleeding (BOP) index was determined by the presence/absence of bleeding ≈30 seconds after probing

**Measure:** Bleeding on probing

**Time Frame:** BOP will be recorded at baseline, at day 42 and 47

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 25 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Adana

**Country:** Turkey

**Facility:** Cukurova University Faculty of Dentistry

#### Overall Officials

**Official 1:**

**Affiliation:** Professor Doctor

**Name:** Cenk Haytac, phd

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** The data will be shared upon request

**Description:** The data will be shared upon request

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** The data is ready and can be shared for two years

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007239

- Term: Infections

- ID: D000005882

- Term: Gingival Diseases

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M9003

- Name: Gingivitis

- Relevance: HIGH

- As Found: Gingivitis

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8994

- Name: Gingival Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005891

- Term: Gingivitis

### Misc Info Module

- Version Holder: 2024-05-31
