Probiotics Effects to Initial Periodontal Treatment

Not Applicable

Completed

• Conditions: Chronic Periodontitis
• Interventions: Dietary Supplement: probiotic or natural yoghurt; Procedure: SRP

• Registration Number: NCT05408364
• Lead Sponsor: Marmara University

Brief Summary

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

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 Timeline

• Status Verified: 2011-03
• Study Start: 2011-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-06-02
• Last Update Submitted: 2022-06-02
• Study First Posted: 2022-06-07
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Natural yoghurt	SRP	SRP+nature yogurt (Danone® yogurt, Luleburgaz, Türkiye)
Natural yoghurt	probiotic or natural yoghurt	SRP+nature yogurt (Danone® yogurt, Luleburgaz, Türkiye)
Probiotic yoghurt	probiotic or natural yoghurt	SRP+probiotic containing yogurt (Danone Activia® Plain, Luleburgaz, Türkiye)
Probiotic yoghurt	SRP	SRP+probiotic containing yogurt (Danone Activia® Plain, Luleburgaz, Türkiye)

Primary Outcome Measures

Name	Time	Method
Probing Depth	28 days	Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Marmara University; 🇹🇷 İstanbul, Maltepe, Turkey