Probiotics Effects to Initial Periodontal Treatment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Dietary Supplement: probiotic or natural yoghurt
* Procedure: SRP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic periodontitis, bifidobacterium, dental scaling, probiotic, root planing