Probiotic Yoghurt Effect on Experimental Gingivitis

Early Phase 1

Completed

• Conditions: Gingivitis
• Interventions: Dietary Supplement: Natural Yoghurt; Dietary Supplement: Probiotic Yoghurt

• Registration Number: NCT02546206
• Lead Sponsor: Marmara University

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2015-08
• Study First Submitted: 2015-08-30
• Study First Submitted QC: 2015-09-08
• Last Update Submitted: 2015-09-08
• Study First Posted: 2015-09-10
• Last Update Posted: 2015-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Natural Yoghurt	Natural Yoghurt	Natural yoghurt consumption
Probiotic Yoghurt	Probiotic Yoghurt	Probiotic yoghurt consumption

Primary Outcome Measures

Name	Time	Method
Bleeding on probing	33 days after yoghurt consumption	Bleeding on probing is defined as presence of bleeding from gingival sulcus during the probing of this area via periodontal probe.

Secondary Outcome Measures

Name	Time	Method
Plaque Index	33 days after yoghurt consumption	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.)
Gingival Index	33 days after yoghurt consumption	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.)

Trial Locations

Locations (1)

Marmara University, Faculty of Dentistry, Department of Periodontology; 🇹🇷 Istanbul, Sisli/Nisantasi, Turkey