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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05211219
Other study ID # 03/2020-18
Secondary ID 6268
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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