The Role of Probiotics in Periodontal Disease

NCT05211219 | Completed

• 2 other identifiers: 03/2020-186268
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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

Keywords

Periodontal disease; Probiotics; Prebiotics

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (3)

• Clinical attachment level

  Baseline

• Clinical attachment level

  1st month

• Clinical attachment level

  3rd month

Study Arms (3)

Probiotics

EXPERIMENTAL

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

Dietary Supplement: Probiotics

Kefir

EXPERIMENTAL

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

Dietary Supplement: AOÇ Kefir

Control

OTHER

the control group was advised without additional food supplements.

Other: Food without additional food supplements

Interventions

Probiotics 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.

Also known as: Probest Defense

Probiotics

AOÇ Kefir DIETARY_SUPPLEMENT

AOÇ Kefir

Kefir

Food without additional food supplements OTHER

Food without additional food supplements

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (2)

Gazi University Faculty of Dentistry

Ankara, 06490, Turkey (Türkiye)

Location

Tuğba Şahin

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Probiotics; Food

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: January 27, 2022
• Study Start: January 7, 2021
• Primary Completion: January 7, 2021
• Study Completion: May 28, 2021
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)