Validation of the Clinical and Antimicrobial Effectiveness of a Clorexidine and Sodium DNA Based Mouthwash in Patients With Stage III and IV Periodontitis: a Randomized-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Subgingival biofilm
研究概览
简要总结
Sodium DNA has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. The aim of this RCT study is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine 0.2% + Sodium DNA and Chlorhexidine 0.2% at two weeks, compared with a placebo, on patients with stage III or IV periodontitis.
详细描述
Sodium DNA has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. The aim of this RCTstudy is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine 0.2% + Sodium DNA and Chlorhexidine 0.20% for 2 weeks of therapy, compared with a placebo, on patients with stage III or IV periodontitis. The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Sealed envelopes
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically diagnosed with stage III or IV periodontitis according to the EFP/AAP 2017 criteria.
排除标准
- •Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
- •Pregnancy.
- •Systemic diseases.
研究组 & 干预措施
Chlorhexidine 0,20% mouthwash
Patients are treated with a mouthwash containing Chlorhexidine 0,20%
干预措施: Non-surgical periodontal treatment (Procedure)
Placebo mouthwash
Patients are treated with a placebo mouthwash
干预措施: Non-surgical periodontal treatment (Procedure)
Chlorhexidine 0,2% + Sodium DNA mouthwash
Patients are treated with a mouthwash containing Chlorhexidine 0,2% + Sodium DNA
干预措施: Non-surgical periodontal treatment (Procedure)
结局指标
主要结局
Subgingival biofilm
时间窗: 6 months
Subgingival biofilm collected with sterile paper strips and analyzed by polimerase chain reaction
FMBS
时间窗: 6 months
Full mouth bleeding score
次要结局
未报告次要终点
研究者
Gaetano Isola
Researcher
University of Catania