Clinical trial NCT05211219: The Role of Probiotics in Periodontal Disease
Official title: The Role of Probiotics in Preventing Dysbiosis in Periodontal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: Periodontal disease
Probiotics
Prebiotics
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Periodontal probing depth
timeFrame: Baseline
measure: Periodontal probing depth
timeFrame: 1st month
measure: Periodontal probing depth
timeFrame: 3rd month
measure: Gingival index
timeFrame: Baseline
measure: Gingival index
timeFrame: 1st month
measure: Gingival index
timeFrame: 3rd month
measure: Microbiological sample
timeFrame: Baseline
measure: Microbiological sample
timeFrame: 1st month
measure: Microbiological sample
timeFrame: 3rd month
measure: Plaque index
timeFrame: Baseline
measure: Plaque index
timeFrame: 1st month
measure: Plaque index
timeFrame: 3rd month
measure: Bleeding on probing
timeFrame: Baseline
measure: Bleeding on probing
timeFrame: 1st month
measure: Bleeding on probing
timeFrame: 3rd month
Secondary outcomes:
measure: Clinical attachment level
timeFrame: Baseline
measure: Clinical attachment level
timeFrame: 1st month
measure: Clinical attachment level
timeFrame: 3rd month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Dentistry
city: Ankara
country: Turkey
facility: Tuğba Şahin
Study officials:
References: