Probiotics Effects to Initial Periodontal Treatment

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05408364
• Other study ID #: MAR-2011-03-30-24
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: April 2013

Study information

• Verified date: March 2011
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Dietary Supplement:
• probiotic or natural yoghurt
Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt

Procedure:
• SRP
Scalling and root planing

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul	Maltepe

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing Depth	Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.	28 days
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.)	28 days
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.)	28 days
Secondary	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
Secondary	Clinical attachment level	The distance from the cementoenamel junction to the bottom of the periodontal pocket.	28 days
Secondary	microbiological parameters	The number of obligate anaerobic bacteria and Bifidobacterium anaerobes	28 days