Probiotic Yoghurt Effect on Experimental Gingivitis

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

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 Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Dietary supplement: Probiotic Yoghurt; Dietary supplement: Natural Yoghurt

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Turkey
  • Sisli/Nisantasi
    • Istanbul, Sisli/Nisantasi, Turkey, 34365
      • Marmara University, Faculty of Dentistry, Department of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic Yoghurt; Probiotic yoghurt consumption	Dietary supplement: Probiotic Yoghurt; Probiotic yoghurt consumption
Placebo Comparator: Natural Yoghurt; Natural yoghurt consumption	Dietary supplement: Natural Yoghurt; Natural yoghurt consumption

What is the study measuring?

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

Other 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.	33 days after yoghurt consumption
Gingival crevicular fluid Interleukin-1beta levels		33 days after yoghurt consumption

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: Tuğçe Yalnızoğlu, PhD, Marmara University, Faculty of Dentistry, Department of Periodontology; Study Director: Bahar Kuru, Prof Dr, Marmara University, Faculty of Dentistry, Department of Periodontology

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: August 30, 2015
• First Submitted That Met QC Criteria: September 8, 2015
• First Posted (Estimate): September 10, 2015

Study Record Updates

• Last Update Posted (Estimate): September 10, 2015
• Last Update Submitted That Met QC Criteria: September 8, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Probiotics; Bifidobacterium; Gingival crevicular fluid; Interleukin-1beta; Gingivitis
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: MAR-2011-10-11/14