Probiotics Effects to Initial Periodontal Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Dietary supplement: probiotic or natural yoghurt; Procedure: SRP

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Maltepe
    • İstanbul, Maltepe, Turkey, 34854
      • Marmara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Natural yoghurt; SRP+nature yogurt (Danone® yogurt, Luleburgaz, Türkiye)	Dietary supplement: probiotic or natural yoghurt; Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt; Procedure: SRP; Scalling and root planing
Experimental: Probiotic yoghurt; SRP+probiotic containing yogurt (Danone Activia® Plain, Luleburgaz, Türkiye)	Dietary supplement: probiotic or natural yoghurt; Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt; Procedure: SRP; Scalling and root planing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Depth	Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	28 days
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.)	28 days
Bleeding on probing	Bleeding on probing is defined as presence of bleeding from gingival sulcus during the probing of this area via periodontal probe.	28 days
Clinical attachment level	The distance from the cementoenamel junction to the bottom of the periodontal pocket.	28 days
microbiological parameters	The number of obligate anaerobic bacteria and Bifidobacterium anaerobes	28 days

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Study Director: Bahar Kuru, Prof. Dr., Marmara University, Faculty of Dentistry, Department of Periodontology; Principal Investigator: Hafize Öztürk Özener, Dr., Marmara University, Faculty of Dentistry, Department of Periodontology

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: probiotic; chronic periodontitis; root planing; dental scaling; bifidobacterium
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: MAR-2011-03-30-24