Evaluation of the Effect of Streptococcus Salivarius K12 Probiotic in the Treatment of Periodontitis
NCT ID: NCT06871540
Last Updated: 2025-03-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-10-01
Study Completion Date
2024-06-30
Brief Summary
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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
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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Detailed Description
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Conditions
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Periodontitis Stage III
Probiotic
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Study Groups
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Test Grubu
Group Type
ACTIVE_COMPARATOR
Probiotic Agent
Intervention Type
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
Intervention Type
OTHER
Patients in the control group received non-surgical periodontal treatment only.
Control
Group Type
OTHER
Non-Surgical Intervention
Intervention Type
OTHER
Patients in the control group received non-surgical periodontal treatment only.
Interventions
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Probiotic Agent
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.
Intervention Type
OTHER
Non-Surgical Intervention
Patients in the control group received non-surgical periodontal treatment only.
Intervention Type
OTHER
Eligibility Criteria
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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
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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AYŞENUR ŞAHİN
OTHER
Sponsor Role
lead
Responsible Party
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AYŞENUR ŞAHİN
Research assistant
Responsibility Role
SPONSOR_INVESTIGATOR
Locations
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İnönü Üniversitesi Diş Hekimliği Fakültesi
Malatya, Battalgazi, Turkey (Türkiye)
Site Status
Countries
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Turkey (Türkiye)
References
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Other Identifiers
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INU-DHF-AS-01
Identifier Type: -
Identifier Source: org_study_id
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