Probiotic Yoghurt Effect on Experimental Gingivitis

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546206
• Other study ID #: MAR-2011-10-11/14
• Status: Completed
• Phase: Phase 0
• First received: August 30, 2015
• Last updated: September 8, 2015
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: August 2015
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 26 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gingivitis

Intervention

Dietary Supplement:
• Probiotic Yoghurt
Probiotic yoghurt consumption
• Natural Yoghurt
Natural yoghurt consumption

Locations

Country	Name	City	State
Turkey	Marmara University, Faculty of Dentistry, Department of Periodontology	Istanbul	Sisli/Nisantasi

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	Gingival crevicular fluid Interleukin-1beta levels		33 days after yoghurt consumption	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes