Probiotics Effects to Initial Periodontal Treatment

NCT ID: NCT05408364

Last Updated: 2022-06-07

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

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-04-30

Brief Summary

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The aim of this study is to evaluate the clinical and microbiological effects of Bifidobacterium animalis subsp. lactis DN-173010 containing yoghurt as an adjunct to mechanical periodontal treatment.

Detailed Description

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The aim of this study is to evaluate the clinical and microbiological effects of Bifidobacterium animalis subsp. lactis DN-173010 containing yoghurt as an adjunct to mechanical periodontal treatment.

Thirty chronic periodontitis patients were randomized into 2 groups. As adjunctive to MPT, Group 1 consumed 2×108 CFU/day of Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt while Group 2 natural yoghurt once daily for 28 days. Subgingival plaque samples were obtained from 2 periodontal sites with probing pocket depth (PPD) of 4≤PPD\<7 mm via paper-points at baseline, 28th day, 3rd month. Samples were cultured to evaluate total viable count (TVC), the proportions of obligate anaerobes (OA) and Bifidobacterium species (B) (TVC%). The full-mouth recorded clinical parameters were plaque index, gingival index, PPD, bleeding on probing, and clinical attachment level.

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Individuals and doctor were blinded to the study groups allocation. Before statistical analysis, the blind study coordinator broke the code to allocate the indivuals to the groups.

Study Groups

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Natural yoghurt

SRP+nature yogurt (Danone® yogurt, Luleburgaz, Türkiye)

Group Type PLACEBO_COMPARATOR

probiotic or natural yoghurt

Intervention Type DIETARY_SUPPLEMENT

Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt

SRP

Intervention Type PROCEDURE

Scalling and root planing

Probiotic yoghurt

SRP+probiotic containing yogurt (Danone Activia® Plain, Luleburgaz, Türkiye)

Group Type EXPERIMENTAL

probiotic or natural yoghurt

Intervention Type DIETARY_SUPPLEMENT

Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt

SRP

Intervention Type PROCEDURE

Scalling and root planing

Interventions

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probiotic or natural yoghurt

Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt

Intervention Type DIETARY_SUPPLEMENT

SRP

Scalling and root planing

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* chronic periodontitis patients with radiographically detected horizontal bone loss
* the presence of at least 2 teeth with one approximal site with a probing pocket depth (PPD) of 4≤SD\<7 mm (5-7 mm) and a GI of ≥2 mm in each quadrant,
* previously untreated periodontitis, systemically healthy

Exclusion Criteria

* Systemic diseases
* Antibiotics and anti-inflammatory drugs within 3 months before the study
* Untreated caries lesions or local retention factors
* Allergic reactions to lactose or fermented milk products
* Previous probiotic supplements in diet
* Smoking
* Pregnancy
Minimum Eligible Age

18 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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Bahar Kuru, Prof. Dr.

Role: STUDY_DIRECTOR

Marmara University, Faculty of Dentistry, Department of Periodontology

Hafize Öztürk Özener, Dr.

Role: PRINCIPAL_INVESTIGATOR

Marmara University, Faculty of Dentistry, Department of Periodontology

Locations

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Marmara University

Istanbul, Maltepe, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MAR-2011-03-30-24

Identifier Type: -

Identifier Source: org_study_id

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