NCT05211219: tropipd

The Role of Probiotics in Periodontal Disease

Completed NA Last updated 15 February 2023

What this trial tests

NA trial testing Probiotics in Periodontal Diseases in 36 participants. Completed in 28 May 2021.

Timeline

7 January 2021

Primary endpoint
7 January 2021

28 May 2021

Quick facts

Lead sponsor	Gazi University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	36
Start date	7 January 2021
Primary completion	7 January 2021
Estimated completion	28 May 2021
Sites	2 locations across Turkey (Türkiye)

Drugs / interventions tested

• Probiotics — full drug profile →
• AOÇ Kefir
• Food without additional food supplements

Conditions studied

• Periodontal Diseases — all drugs for Periodontal Diseases →

Sponsor

Gazi University

Who can join

Adults 18 to 70, any sex, with Periodontal Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent advances in therapeutic probiotics: insights from human trials.
   Cho M-Y, Eom J-H, Choi E-M, Yang S-J, et al · · 2025 · cited 17× · PMID 40261032 · DOI 10.1128/cmr.00240-24
2. The role of probiotics for preventing dysbiosis in periodontal disease: a randomized controlled trial.
   Şahin T, Akca G, Özmeriç N. · · 2024 · cited 8× · PMID 38812644 · DOI 10.55730/1300-0144.5798