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Probiotic Yoghurt Effect on Experimental Gingivitis

Primary Purpose

Gingivitis

Status
Completed
Phase
Early Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
Probiotic Yoghurt
Natural Yoghurt
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis focused on measuring Bifidobacterium, Gingivitis, Gingival crevicular fluid, Interleukin-1beta, Probiotics

Eligibility Criteria

16 Years - 26 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • No or minimal clinical signs of gingival inflammation
  • Gingival Index ≤ 1
  • No probing depth (Probing depth > 3 mm)
  • No approximal attachment loss > 2 mm
  • Non smokers

Exclusion Criteria:

  • Systemic diseases
  • Antibiotics and anti-inflammatory drugs within 3 months before the study
  • Untreated caries lesions or local retention factors
  • Mouth-breathing
  • Allergies
  • Previous probiotic supplements in diet

Sites / Locations

  • Marmara University, Faculty of Dentistry, Department of Periodontology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic Yoghurt

Natural Yoghurt

Arm Description

Probiotic yoghurt consumption

Natural yoghurt consumption

Outcomes

Primary Outcome Measures

Bleeding on probing
Bleeding on probing is defined as presence of bleeding from gingival sulcus during the probing of this area via periodontal probe.

Secondary Outcome Measures

Gingival Index
Each of the buccal, mesial, lingual and distal surfaces of the gingival tissues is given a score of 0-3. (0 = Normal gingiva. 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema and glazing. Bleeding on probing. 3. Severe inflammation -marked redness and edema.)
Plaque Index
Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. (0 = No plaque in the gingival area. 1 = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface. 2 = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye. 3 = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface. Tendency to spontaneous bleeding.)

Full Information

First Posted
August 30, 2015
Last Updated
September 8, 2015
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT02546206
Brief Title
Probiotic Yoghurt Effect on Experimental Gingivitis
Official Title
Influence of Probiotics on Clinical Parameters and GCF Levels of Interleukin-1β in Experimental Gingivitis: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study was to evaluate the effects of probiotic yoghurt on the development of gingival inflammation. Fifty-one periodontally healthy individuals were given standard oral hygiene instructions and randomly divided into two groups. The test group subjects (n=26) consumed probiotic yoghurt containing Bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural yoghurt for 28 days. Following yoghurt consumption, mechanical plaque control was interrupted for the next 5 days in both groups. Gingival crevicular fluid (GCF) samples and clinical data (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected at baseline, after 28 and 33 days. Interleukin-1β levels were determined in GCF by ELISA.
Detailed Description
Probiotics are viable bacteria with scientifically confirmed health benefits for gastrointestinal system. However, there is paucity of information on its impact in periodontal disease. The aim of this study was to evaluate the effects of probiotic yoghurt on the development of gingival inflammation. Fifty-one periodontally healthy individuals were given standard oral hygiene instructions and randomly divided into two groups. The test group subjects (n=26) consumed probiotic yoghurt containing Bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural yoghurt for 28 days. Following yoghurt consumption, mechanical plaque control was interrupted for the next 5 days in both groups. Gingival crevicular fluid (GCF) samples and clinical data (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected at baseline, after 28 and 33 days. Interleukin-1β levels were determined in GCF by ELISA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
Bifidobacterium, Gingivitis, Gingival crevicular fluid, Interleukin-1beta, Probiotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic Yoghurt
Arm Type
Experimental
Arm Description
Probiotic yoghurt consumption
Arm Title
Natural Yoghurt
Arm Type
Placebo Comparator
Arm Description
Natural yoghurt consumption
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic Yoghurt
Intervention Description
Probiotic yoghurt consumption
Intervention Type
Dietary Supplement
Intervention Name(s)
Natural Yoghurt
Intervention Description
Natural yoghurt consumption
Primary Outcome Measure Information:
Title
Bleeding on probing
Description
Bleeding on probing is defined as presence of bleeding from gingival sulcus during the probing of this area via periodontal probe.
Time Frame
33 days after yoghurt consumption
Secondary Outcome Measure Information:
Title
Gingival Index
Description
Each of the buccal, mesial, lingual and distal surfaces of the gingival tissues is given a score of 0-3. (0 = Normal gingiva. 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema and glazing. Bleeding on probing. 3. Severe inflammation -marked redness and edema.)
Time Frame
33 days after yoghurt consumption
Title
Plaque Index
Description
Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. (0 = No plaque in the gingival area. 1 = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface. 2 = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye. 3 = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface. Tendency to spontaneous bleeding.)
Time Frame
33 days after yoghurt consumption
Other Pre-specified Outcome Measures:
Title
Probing Depth
Description
Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.
Time Frame
33 days after yoghurt consumption
Title
Gingival crevicular fluid Interleukin-1beta levels
Time Frame
33 days after yoghurt consumption

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: No or minimal clinical signs of gingival inflammation Gingival Index ≤ 1 No probing depth (Probing depth > 3 mm) No approximal attachment loss > 2 mm Non smokers Exclusion Criteria: Systemic diseases Antibiotics and anti-inflammatory drugs within 3 months before the study Untreated caries lesions or local retention factors Mouth-breathing Allergies Previous probiotic supplements in diet
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuğçe Yalnızoğlu, PhD
Organizational Affiliation
Marmara University, Faculty of Dentistry, Department of Periodontology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bahar Kuru, Prof Dr
Organizational Affiliation
Marmara University, Faculty of Dentistry, Department of Periodontology
Official's Role
Study Director
Facility Information:
Facility Name
Marmara University, Faculty of Dentistry, Department of Periodontology
City
Istanbul
State/Province
Sisli/Nisantasi
ZIP/Postal Code
34365
Country
Turkey

12. IPD Sharing Statement

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Probiotic Yoghurt Effect on Experimental Gingivitis

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