Skip to main content
Clinical Trials/NCT05408364
NCT05408364CompletedNot Applicable

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

Marmara University2 sites in 1 country30 target enrollmentStarted: April 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Probing Depth

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Masking Description

Individuals and doctor were blinded to the study groups allocation. Before statistical analysis, the blind study coordinator broke the code to allocate the indivuals to the groups.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • Pregnancy

Outcomes

Primary Outcomes

Probing Depth

Time Frame: 28 days

Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.

Secondary Outcomes

  • Gingival Index(28 days)
  • Plaque Index(28 days)
  • Clinical attachment level(28 days)
  • microbiological parameters(28 days)
  • Bleeding on probing(28 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials