Clinical trial NCT06871540: Evaluation of the Effect of Streptococcus Salivarius K12 Probiotic in the Treatment of Periodontitis
Official title: Evaluation of the Effect of Streptococcus Salivarius K12 Probiotic in the Treatment of Periodontitis: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis Stage III
Probiotic
Keywords: Microbiology, Periodontitis, Probiotics, Cytokines
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in Porphyromonas gingivalis at 3 months
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: İnönü Üniversitesi Diş Hekimliği Fakültesi
state: Battalgazi
Study officials:
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