The Role of Probiotics in Periodontal Disease (tropipd)

The Role of Probiotics in Preventing Dysbiosis in Periodontal Disease

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).

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Dietary supplement: Probiotics; Dietary supplement: AOÇ Kefir; Other: Food without additional food supplements

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06490
    • Gazi University Faculty of Dentistry
  • Ankara, Turkey, 06560
    • Tuğba Şahin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics; The probiotics group was advised to consume a chewable tablet once a day in 14 days.	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.; Other Names: Probest Defense
Experimental: Kefir; The kefir group was advised to consume kefir as a liquid once a day in 14 days.	Dietary supplement: AOÇ Kefir; AOÇ Kefir
Other: Control; the control group was advised without additional food supplements.	Other: Food without additional food supplements; Food without additional food supplements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level	The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.	Baseline
Clinical attachment level	The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.	1st month
Clinical attachment level	The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.	3rd month

Collaborators and Investigators

• Sponsor: Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2021
• Primary Completion (Actual): January 7, 2021
• Study Completion (Actual): May 28, 2021

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: January 16, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Probiotics; Prebiotics; Periodontal disease
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: 03/2020-18; 6268 (Gazi University Project of Science Investigation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No