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NCT Number: NCT05408364

Probiotics Effects to Initial Periodontal Treatment

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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

probiotic or natural yoghurt

Dietary Supplement

Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt

SRP

Procedure

Scalling and root planing

Primary outcomes

  1. Probing Depth

    Time frame: 28 days

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

Secondary outcomes

  1. Gingival Index

    Time frame: 28 days

    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: 28 days

    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.)

  3. Bleeding on probing

    Time frame: 28 days

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

  4. Clinical attachment level

    Time frame: 28 days

    The distance from the cementoenamel junction to the bottom of the periodontal pocket.

  5. microbiological parameters

    Time frame: 28 days

    The number of obligate anaerobic bacteria and Bifidobacterium anaerobes

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Clinical and Microbiological Evaluation of Probiotics as an Adjunct to Initial Periodontal Treatment in Chronic Periodontitis

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 7, 2022
Registry last updated
Jun 7, 2022

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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