The Role of Probiotics in Periodontal Disease (tropipd)
Primary Purpose
Periodontal Diseases
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Probiotics
AOÇ Kefir
Food without additional food supplements
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases focused on measuring Periodontal disease, Probiotics, Prebiotics
Eligibility Criteria
Inclusion Criteria:
- Systemically healthy
- Individuals over 18
- Periodontitis (4-6 mm pockets) patients with 3 teeth in each half of the jaws except wisdom tooth
- Non-smoker
- Not using probiotic tablets/capsules and consuming no more than 3-4 probiotic food.
Exclusion Criteria:
- Antibiotic use within 6 months.
- Breastfeeding or pregnancy.
- Acute oral lesions or necrotizing ulcerative periodontitis
- Diabetes, rheumatic fever, lung, kidney disease history and drug use that will affect periodontal tissues
- Patients who smoke or who did not stop until last year
- Use of probiotics tablets or capsules
- Probiotic food consumption not more than 3-4 times a week
Sites / Locations
- Gazi University Faculty of Dentistry
- Tuğba Şahin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Probiotics
Kefir
Control
Arm Description
The probiotics group was advised to consume a chewable tablet once a day in 14 days.
The kefir group was advised to consume kefir as a liquid once a day in 14 days.
the control group was advised without additional food supplements.
Outcomes
Primary Outcome Measures
Periodontal probing depth
the distance from the gingival margin to pocket base.
Periodontal probing depth
the distance from the gingival margin to pocket base.
Periodontal probing depth
the distance from the gingival margin to pocket base.
Gingival index
It is an index that shows the severity and quantity of gingival inflammation.
Gingival index
It is an index that shows the severity and quantity of gingival inflammation.
Gingival index
It is an index that shows the severity and quantity of gingival inflammation.
Microbiological sample
Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia, Porphyromonas gingivalis, and Treponema denticola.
Microbiological sample
Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia, Porphyromonas gingivalis, and Treponema denticola.
Microbiological sample
Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia, Porphyromonas gingivalis, and Treponema denticola.
Plaque index
It is an index that shows the amount of microbial dental plaque on the teeth.
Plaque index
It is an index that shows the amount of microbial dental plaque on the teeth.
Plaque index
It is an index that shows the amount of microbial dental plaque on the teeth.
Bleeding on probing
Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.
Bleeding on probing
Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.
Bleeding on probing
Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.
Secondary Outcome Measures
Clinical attachment level
The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.
Clinical attachment level
The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.
Clinical attachment level
The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05211219
Brief Title
The Role of Probiotics in Periodontal Disease
Acronym
tropipd
Official Title
The Role of Probiotics in Preventing Dysbiosis in Periodontal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
January 7, 2021 (Actual)
Study Completion Date
May 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this randomized controlled trial, it was aimed to evaluate the effect of probiotics (chewable tablets) and kefir consumption in the initial periodontal treatment of periodontitis patients on the change of oral microbiota and treatment. In this clinical trial, 36 systemically healthy volunteers who were diagnosed with periodontitis who were admitted to Gazi University Faculty of Dentistry, Department of Periodontology were included. Besides the inclusion criteria, the nutritional habits of the patients were evaluated by questionnaire. For diagnosis, plaque index, gingival index, bleeding on probing, periodontal probing depth and clinical attachment level were examined. Patients were randomly divided into 3 groups; probiotic, kefir and control group. Following the periodontal diagnosis, clinical index records of the patients and subgingival microbial samples were obtained. The supragingival plaque sample was removed and the subgingival microbial dental plaque sample was gently taken with a sterile Gracey curette. In the same session, periodontal initial treatment was started. According to the groups, they were involved simultaneously with the treatment, kefir group was advised to consume kefir as a liquid once a day in 14 days; probiotics group was advised to consume as a chewable tablet once a day in 14 days; the control group was advised without additional food supplements. Periodontal indexes were repeated in the 1st and 3rd months. Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia (T. forsythia), Porphyromonas gingivalis (P. gingivalis), and Treponema denticola (T. denticola).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
Periodontal disease, Probiotics, Prebiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotics
Arm Type
Experimental
Arm Description
The probiotics group was advised to consume a chewable tablet once a day in 14 days.
Arm Title
Kefir
Arm Type
Experimental
Arm Description
The kefir group was advised to consume kefir as a liquid once a day in 14 days.
Arm Title
Control
Arm Type
Other
Arm Description
the control group was advised without additional food supplements.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Other Intervention Name(s)
Probest Defense
Intervention Description
According to the groups, they were involved simultaneously with the treatment, kefir group was advised to consume kefir as a liquid once a day in 14 days; the probiotics group was advised to consume as a chewable tablet once a day in 14 days; the control group was advised without additional food supplements.
Intervention Type
Dietary Supplement
Intervention Name(s)
AOÇ Kefir
Intervention Description
AOÇ Kefir
Intervention Type
Other
Intervention Name(s)
Food without additional food supplements
Intervention Description
Food without additional food supplements
Primary Outcome Measure Information:
Title
Periodontal probing depth
Description
the distance from the gingival margin to pocket base.
Time Frame
Baseline
Title
Periodontal probing depth
Description
the distance from the gingival margin to pocket base.
Time Frame
1st month
Title
Periodontal probing depth
Description
the distance from the gingival margin to pocket base.
Time Frame
3rd month
Title
Gingival index
Description
It is an index that shows the severity and quantity of gingival inflammation.
Time Frame
Baseline
Title
Gingival index
Description
It is an index that shows the severity and quantity of gingival inflammation.
Time Frame
1st month
Title
Gingival index
Description
It is an index that shows the severity and quantity of gingival inflammation.
Time Frame
3rd month
Title
Microbiological sample
Description
Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia, Porphyromonas gingivalis, and Treponema denticola.
Time Frame
Baseline
Title
Microbiological sample
Description
Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia, Porphyromonas gingivalis, and Treponema denticola.
Time Frame
1st month
Title
Microbiological sample
Description
Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia, Porphyromonas gingivalis, and Treponema denticola.
Time Frame
3rd month
Title
Plaque index
Description
It is an index that shows the amount of microbial dental plaque on the teeth.
Time Frame
Baseline
Title
Plaque index
Description
It is an index that shows the amount of microbial dental plaque on the teeth.
Time Frame
1st month
Title
Plaque index
Description
It is an index that shows the amount of microbial dental plaque on the teeth.
Time Frame
3rd month
Title
Bleeding on probing
Description
Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.
Time Frame
Baseline
Title
Bleeding on probing
Description
Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.
Time Frame
1st month
Title
Bleeding on probing
Description
Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.
Time Frame
3rd month
Secondary Outcome Measure Information:
Title
Clinical attachment level
Description
The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.
Time Frame
Baseline
Title
Clinical attachment level
Description
The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.
Time Frame
1st month
Title
Clinical attachment level
Description
The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.
Time Frame
3rd month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Systemically healthy
Individuals over 18
Periodontitis (4-6 mm pockets) patients with 3 teeth in each half of the jaws except wisdom tooth
Non-smoker
Not using probiotic tablets/capsules and consuming no more than 3-4 probiotic food.
Exclusion Criteria:
Antibiotic use within 6 months.
Breastfeeding or pregnancy.
Acute oral lesions or necrotizing ulcerative periodontitis
Diabetes, rheumatic fever, lung, kidney disease history and drug use that will affect periodontal tissues
Patients who smoke or who did not stop until last year
Use of probiotics tablets or capsules
Probiotic food consumption not more than 3-4 times a week
Facility Information:
Facility Name
Gazi University Faculty of Dentistry
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Tuğba Şahin
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Role of Probiotics in Periodontal Disease
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