The Role of Probiotics in Periodontal Disease

Periodontal Diseases Clinical Trial

— tropipd  

Official title:

The Role of Probiotics in Preventing Dysbiosis in Periodontal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05211219
• Other study ID #: 03/2020-18
• Secondary ID: 6268
• Status: Completed
• Phase: N/A
• Start date: January 7, 2021
• Est. completion date: May 28, 2021

Study information

• Verified date: February 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 28, 2021
• Est. primary completion date: January 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Systemically healthy

2. Individuals over 18

3. Periodontitis (4-6 mm pockets) patients with 3 teeth in each half of the jaws except wisdom tooth

4. Non-smoker

5. Not using probiotic tablets/capsules and consuming no more than 3-4 probiotic food.

Exclusion Criteria:

1. Antibiotic use within 6 months.

2. Breastfeeding or pregnancy.

3. Acute oral lesions or necrotizing ulcerative periodontitis

4. Diabetes, rheumatic fever, lung, kidney disease history and drug use that will affect periodontal tissues

5. Patients who smoke or who did not stop until last year

6. Use of probiotics tablets or capsules

7. Probiotic food consumption not more than 3-4 times a week

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Dietary Supplement:
• Probiotics
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.
• AOÇ Kefir
AOÇ Kefir

Other:
• Food without additional food supplements
Food without additional food supplements

Locations

Country	Name	City	State
Turkey	Gazi University Faculty of Dentistry	Ankara
Turkey	Tugba Sahin	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periodontal probing depth	the distance from the gingival margin to pocket base.	Baseline
Primary	Periodontal probing depth	the distance from the gingival margin to pocket base.	1st month
Primary	Periodontal probing depth	the distance from the gingival margin to pocket base.	3rd month
Primary	Gingival index	It is an index that shows the severity and quantity of gingival inflammation.	Baseline
Primary	Gingival index	It is an index that shows the severity and quantity of gingival inflammation.	1st month
Primary	Gingival index	It is an index that shows the severity and quantity of gingival inflammation.	3rd month
Primary	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
Primary	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
Primary	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
Primary	Plaque index	It is an index that shows the amount of microbial dental plaque on the teeth.	Baseline
Primary	Plaque index	It is an index that shows the amount of microbial dental plaque on the teeth.	1st month
Primary	Plaque index	It is an index that shows the amount of microbial dental plaque on the teeth.	3rd month
Primary	Bleeding on probing	Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.	Baseline
Primary	Bleeding on probing	Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.	1st month
Primary	Bleeding on probing	Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.	3rd month
Secondary	Clinical attachment level	The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.	Baseline
Secondary	Clinical attachment level	The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.	1st month
Secondary	Clinical attachment level	The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.	3rd month