Probiotic Yoghurt Effect on Experimental Gingivitis

NCT ID: NCT02546206

Last Updated: 2015-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Probiotic Yoghurt

Probiotic yoghurt consumption

Group Type EXPERIMENTAL

Probiotic Yoghurt

Intervention Type DIETARY_SUPPLEMENT

Probiotic yoghurt consumption

Natural Yoghurt

Natural yoghurt consumption

Group Type PLACEBO_COMPARATOR

Natural Yoghurt

Intervention Type DIETARY_SUPPLEMENT

Natural yoghurt consumption

Interventions

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Probiotic Yoghurt

Probiotic yoghurt consumption

Intervention Type DIETARY_SUPPLEMENT

Natural Yoghurt

Natural yoghurt consumption

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tuğçe Yalnızoğlu, PhD

Role: PRINCIPAL_INVESTIGATOR

Marmara University, Faculty of Dentistry, Department of Periodontology

Bahar Kuru, Prof Dr

Role: STUDY_DIRECTOR

Marmara University, Faculty of Dentistry, Department of Periodontology

Locations

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Marmara University, Faculty of Dentistry, Department of Periodontology

Istanbul, Sisli/Nisantasi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MAR-2011-10-11/14

Identifier Type: -

Identifier Source: org_study_id

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