Probiotics Effects to Initial Periodontal Treatment

Sponsor

Marmara University (Other)

Overall Status

Completed

CT.gov ID

NCT05408364

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Periodontitis	Dietary Supplement: probiotic or natural yoghurt Procedure: SRP	N/A

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

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Natural yoghurt SRP+nature yogurt (Danone® yogurt, Luleburgaz, Türkiye)	Dietary Supplement: probiotic or natural yoghurt Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt Procedure: SRP Scalling and root planing
Experimental: Probiotic yoghurt SRP+probiotic containing yogurt (Danone Activia® Plain, Luleburgaz, Türkiye)	Dietary Supplement: probiotic or natural yoghurt Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt Procedure: SRP Scalling and root planing

Arm

Intervention/Treatment

Placebo Comparator: Natural yoghurt

SRP+nature yogurt (Danone® yogurt, Luleburgaz, Türkiye)

Dietary Supplement: probiotic or natural yoghurt

Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt

Procedure: SRP

Scalling and root planing

Experimental: Probiotic yoghurt

SRP+probiotic containing yogurt (Danone Activia® Plain, Luleburgaz, Türkiye)

Dietary Supplement: probiotic or natural yoghurt

Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt

Procedure: SRP

Scalling and root planing

Outcome Measures

Primary Outcome Measures

Probing Depth [28 days]
Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.

Secondary Outcome Measures

Gingival Index [28 days]
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.)
Plaque Index [28 days]
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.)
Bleeding on probing [28 days]
Bleeding on probing is defined as presence of bleeding from gingival sulcus during the probing of this area via periodontal probe.
Clinical attachment level [28 days]
The distance from the cementoenamel junction to the bottom of the periodontal pocket.
microbiological parameters [28 days]
The number of obligate anaerobic bacteria and Bifidobacterium anaerobes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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
Smoking
Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marmara University	İstanbul	Maltepe	Turkey	34854

Sponsors and Collaborators

Marmara University

Investigators

Study Director: Bahar Kuru, Prof. Dr., Marmara University, Faculty of Dentistry, Department of Periodontology
Principal Investigator: Hafize Öztürk Özener, Dr., Marmara University, Faculty of Dentistry, Department of Periodontology