Evaluation of the Effect of Streptococcus Salivarius K12 Probiotic in the Treatment of Periodontitis

NCT06871540 | Completed

• 1 other identifier: INU-DHF-AS-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontitis Stage III; Probiotic

Keywords

Microbiology, Periodontitis, Probiotics, Cytokines

Outcome Measures

Primary Outcomes (1)

• Reduction in Porphyromonas gingivalis at 3 months

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Test Grubu

ACTIVE COMPARATOR

Other: Probiotic Agent; Other: Non-Surgical Intervention

Control

OTHER

Other: Non-Surgical Intervention

Interventions

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.

Test Grubu

Non-Surgical Intervention OTHER

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

Control; Test Grubu

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AYŞENUR ŞAHİN: lead

Study Sites (1)

İnönü Üniversitesi Diş Hekimliği Fakültesi

Malatya, Battalgazi, Turkey (Türkiye)

Location

Related Publications (36)

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MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: October 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)