The Role of Probiotics in Periodontal Disease

NCT ID: NCT05211219

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-07
• Study Completion Date: 2021-05-28

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).

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Probiotics

The probiotics group was advised to consume a chewable tablet once a day in 14 days.

Group Type: EXPERIMENTAL

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

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.

Kefir

The kefir group was advised to consume kefir as a liquid once a day in 14 days.

Group Type: EXPERIMENTAL

AOÇ Kefir

Intervention Type: DIETARY_SUPPLEMENT

AOÇ Kefir

Control

the control group was advised without additional food supplements.

Group Type: OTHER

Food without additional food supplements

Intervention Type: OTHER

Food without additional food supplements

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

AOÇ Kefir

AOÇ Kefir

Intervention Type: DIETARY_SUPPLEMENT

Food without additional food supplements

Food without additional food supplements

Intervention Type: OTHER

Other Intervention Names

Probest Defense

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Nurdan Ozmeric

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gazi University Faculty of Dentistry

Ankara, , Turkey (Türkiye)

Tuğba Şahin

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

6268

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

03/2020-18

Identifier Type: -

Identifier Source: org_study_id