Evaluation of the Effect of Streptococcus Salivarius K12 Probiotic in the Treatment of Periodontitis: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in Porphyromonas gingivalis at 3 months
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Periodontal treatment within sixteen months,
- •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.
研究组 & 干预措施
Test Grubu
干预措施: Probiotic Agent (Other)
Test Grubu
干预措施: Non-Surgical Intervention (Other)
Control
干预措施: Non-Surgical Intervention (Other)
结局指标
主要结局
Reduction in Porphyromonas gingivalis at 3 months
时间窗: From enrollment to the end of treatment at 12 weeks
次要结局
未报告次要终点
研究者
AYŞENUR ŞAHİN
Research assistant
Inonu University