Probiotics Effects to Initial Periodontal Treatment
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
probiotic or natural yoghurt
SRP
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring bifidobacterium, chronic periodontitis, dental scaling, probiotic, root planing
Eligibility Criteria
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
Sites / Locations
- Marmara University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Natural yoghurt
Probiotic yoghurt
Arm Description
SRP+nature yogurt (Danone® yogurt, Luleburgaz, Türkiye)
SRP+probiotic containing yogurt (Danone Activia® Plain, Luleburgaz, Türkiye)
Outcomes
Primary Outcome Measures
Probing Depth
Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.
Secondary Outcome Measures
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.)
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.)
Bleeding on probing
Bleeding on probing is defined as presence of bleeding from gingival sulcus during the probing of this area via periodontal probe.
Clinical attachment level
The distance from the cementoenamel junction to the bottom of the periodontal pocket.
microbiological parameters
The number of obligate anaerobic bacteria and Bifidobacterium anaerobes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05408364
Brief Title
Probiotics Effects to Initial Periodontal Treatment
Official Title
Clinical and Microbiological Evaluation of Probiotics as an Adjunct to Initial Periodontal Treatment in Chronic Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
bifidobacterium, chronic periodontitis, dental scaling, probiotic, root planing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Natural yoghurt
Arm Type
Placebo Comparator
Arm Description
SRP+nature yogurt (Danone® yogurt, Luleburgaz, Türkiye)
Arm Title
Probiotic yoghurt
Arm Type
Experimental
Arm Description
SRP+probiotic containing yogurt (Danone Activia® Plain, Luleburgaz, Türkiye)
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotic or natural yoghurt
Intervention Description
Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt
Intervention Type
Procedure
Intervention Name(s)
SRP
Intervention Description
Scalling and root planing
Primary Outcome Measure Information:
Title
Probing Depth
Description
Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Gingival Index
Description
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.)
Time Frame
28 days
Title
Plaque Index
Description
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.)
Time Frame
28 days
Title
Bleeding on probing
Description
Bleeding on probing is defined as presence of bleeding from gingival sulcus during the probing of this area via periodontal probe.
Time Frame
28 days
Title
Clinical attachment level
Description
The distance from the cementoenamel junction to the bottom of the periodontal pocket.
Time Frame
28 days
Title
microbiological parameters
Description
The number of obligate anaerobic bacteria and Bifidobacterium anaerobes
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahar Kuru, Prof. Dr.
Organizational Affiliation
Marmara University, Faculty of Dentistry, Department of Periodontology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hafize Öztürk Özener, Dr.
Organizational Affiliation
Marmara University, Faculty of Dentistry, Department of Periodontology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University
City
İstanbul
State/Province
Maltepe
ZIP/Postal Code
34854
Country
Turkey
12. IPD Sharing Statement
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Probiotics Effects to Initial Periodontal Treatment
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