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CompletedNCT02546206Updated Sep 10, 2015

Probiotic Yoghurt Effect on Experimental Gingivitis

An Early Phase 1 interventional study of Probiotic Yoghurt and Natural Yoghurt in Gingivitis, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 16 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-10.

Sponsored by Marmara University · Early Phase 1, Interventional, and Prevention

Phase
Early Phase 1
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
16 Years to 26 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gingivitis

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Keywords

  • Bifidobacterium
  • Gingivitis
  • Gingival crevicular fluid
  • Interleukin-1beta
  • Probiotics
03

In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 51 is below the median of 64 across 478 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 26 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Probiotic Yoghurt

    Probiotic yoghurt consumption

    Dietary Supplement: Probiotic Yoghurt

  • Placebo comparator
    Natural Yoghurt

    Natural yoghurt consumption

    Dietary Supplement: Natural Yoghurt

Interventions

  • Dietary supplementProbiotic Yoghurt

    Probiotic yoghurt consumption

  • Dietary supplementNatural Yoghurt

    Natural yoghurt consumption

06

What researchers measure

Primary outcomes

  1. Bleeding on probing

    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 outcomes

  1. 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.)

    Time frame: 33 days after yoghurt consumption

  2. 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.)

    Time frame: 33 days after yoghurt consumption

Other outcomes

  1. Probing Depth

    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

  2. Gingival crevicular fluid Interleukin-1beta levels

    Time frame: 33 days after yoghurt consumption

07

Study locations

1 site
  • Marmara University, Faculty of Dentistry, Department of Periodontology
    Istanbul, Sisli/Nisantasi 34365, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02546206
Lead sponsor
Marmara University
Responsible party
Sponsor
First posted
Sep 10, 2015
Start date
Nov 2011
Primary completion
May 2012
Completion
May 2012
Last update
Sep 10, 2015

Study contacts

Tuğçe Yalnızoğlu, PhD
principal investigator · Marmara University, Faculty of Dentistry, Department of Periodontology
Bahar Kuru, Prof Dr
study director · Marmara University, Faculty of Dentistry, Department of Periodontology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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