Probiotic Yoghurt Effect on Experimental Gingivitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gingivitis

Intervention / Treatment
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* Dietary Supplement: Probiotic Yoghurt
* Dietary Supplement: Natural Yoghurt


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 26 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Yoghurt<br>Probiotic yoghurt consumption | Dietary Supplement: Probiotic Yoghurt<br>* Probiotic yoghurt consumption<br>|
| Placebo Comparator: Natural Yoghurt<br>Natural yoghurt consumption | Dietary Supplement: Natural Yoghurt<br>* Natural yoghurt consumption<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on probing | Bleeding on probing is defined as presence of bleeding from gingival sulcus during the probing of this area via periodontal probe. | 33 days after yoghurt consumption | 

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.) | 33 days after yoghurt consumption | 
| 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.) | 33 days after yoghurt consumption | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bifidobacterium, Gingivitis, Gingival crevicular fluid, Interleukin-1beta, Probiotics