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Completed

NCT Number: NCT02546206

Probiotic Yoghurt Effect on Experimental Gingivitis

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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

16 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Marmara University, Faculty of Dentistry, Department of Periodontology

Istanbul, Sisli/Nisantasi, 34365, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic Yoghurt

Dietary Supplement

Probiotic yoghurt consumption

Natural Yoghurt

Dietary Supplement

Natural yoghurt consumption

Primary outcomes

  1. Bleeding on probing

    Time frame: 33 days after yoghurt consumption

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

Secondary outcomes

  1. Gingival Index

    Time frame: 33 days after yoghurt consumption

    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.)

  2. Plaque Index

    Time frame: 33 days after yoghurt consumption

    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.)

Other outcomes

  1. Probing Depth

    Time frame: 33 days after yoghurt consumption

    Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.

  2. Gingival crevicular fluid Interleukin-1beta levels

    Time frame: 33 days after yoghurt consumption

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Influence of Probiotics on Clinical Parameters and GCF Levels of Interleukin-1β in Experimental Gingivitis: a Randomized Controlled Clinical Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 10, 2015
Registry last updated
Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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