The Role of Probiotics in Periodontal Disease

Study Overview
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Brief Summary
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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).

Official Title
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The Role of Probiotics in Preventing Dysbiosis in Periodontal Disease

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Dietary Supplement: AOÇ Kefir
* Other: Food without additional food supplements


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>The probiotics group was advised to consume a chewable tablet once a day in 14 days. | Dietary Supplement: Probiotics<br>* 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.<br>* Other names: Probest Defense;|
| Experimental: Kefir<br>The kefir group was advised to consume kefir as a liquid once a day in 14 days. | Dietary Supplement: AOÇ Kefir<br>* AOÇ Kefir<br>|
| Other: Control<br>the control group was advised without additional food supplements. | Other: Food without additional food supplements<br>* Food without additional food supplements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal probing depth | the distance from the gingival margin to pocket base. | Baseline | 
| Periodontal probing depth | the distance from the gingival margin to pocket base. | 1st month | 
| Periodontal probing depth | the distance from the gingival margin to pocket base. | 3rd month | 
| Gingival index | It is an index that shows the severity and quantity of gingival inflammation. | Baseline | 
| Gingival index | It is an index that shows the severity and quantity of gingival inflammation. | 1st month | 
| Gingival index | It is an index that shows the severity and quantity of gingival inflammation. | 3rd month | 
| 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. | Baseline | 
| 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. | 1st month | 
| 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. | 3rd month | 
| Plaque index | It is an index that shows the amount of microbial dental plaque on the teeth. | Baseline | 
| Plaque index | It is an index that shows the amount of microbial dental plaque on the teeth. | 1st month | 
| Plaque index | It is an index that shows the amount of microbial dental plaque on the teeth. | 3rd month | 
| Bleeding on probing | Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus. | Baseline | 
| Bleeding on probing | Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus. | 1st month | 
| Bleeding on probing | Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus. | 3rd month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level | The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus. | Baseline | 
| Clinical attachment level | The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus. | 1st month | 
| Clinical attachment level | The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus. | 3rd month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontal disease, Probiotics, Prebiotics