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Completed

NCT Number: NCT06871540

Evaluation Of The Effect Of Streptococcus Salivarius K12 Probiotic In The Treatment Of Periodontitis

Aims: The use of oral probiotics as an adjunct to the treatment of periodontal diseases is known to be beneficial in antagonizing pathogenic microflora and regulating the host immune response. The aim of this clinical study was to evaluate the clinical, microbiologic and biochemical effect of Streptococcus salivarius (S. salivarius) K12 probiotic tablet as an adjunct to scaling and root planing (SRP) treatment in stage 3 periodontitis patients.

Methods: The study included 30 systemically healthy stage 3 periodontitis patients. After non-surgical periodontal treatment, participants were randomly assigned to the test (SRP+Probiotic, n=15) or control (SRP, n=15) group. Patients in the test group used probiotic tablets once daily for 30 days. Clinical (Plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL)), microbiological (Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia, Aggregatibacter actinomycetemcomitans, Fusobacterium nucleatum) and biochemical (IL-6, IL-8, IL-10) measurements were performed at baseline (before SRP), 30. and 90th days. Data were analyzed statistically.

Keywords: Microbiology, Periodontitis, Probiotics, Cytokines

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İnönü Üniversitesi Diş Hekimliği Fakültesi

Malatya, Battalgazi, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female aged 18-60 years,
  • No systemic disease,
  • No periodontal treatment in the last 6 months,
  • No antibiotic therapy in the last 6 months,
  • Diagnosed with stage 3 periodontitis according to the 2017 periodontal disease classification

Exclusion criteria

  • Periodontal treatment within sixteen months,
  • Smoking,
  • Patients with systemic health problems such as diabetes, rheumatoid arthritis, neurological diseases, lung and kidney diseases,
  • Pregnancy or lactation,
  • Acute oral lesions or necrotizing ulcerative periodontitis.

Treatment and study plan

Probiotic Agent

Other

Patients in the test group were instructed to take one tablet immediately after tooth brushing (before bedtime) once daily for 30 consecutive days. Probiotic was administered in tablets containing 1x109 cfu/g S. salivarius K12.

Non-Surgical Intervention

Other

Patients in the control group received non-surgical periodontal treatment only.

Primary outcomes

  1. Reduction in Porphyromonas gingivalis at 3 months

    Time frame: From enrollment to the end of treatment at 12 weeks

Sponsors and collaborators

Lead sponsor

AYŞENUR ŞAHİN

Other

Registry information

Official study title

Evaluation Of The Effect Of Streptococcus Salivarius K12 Probiotic In The Treatment Of Periodontitis: A Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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