Sodium Fluoride, Chlorhexidine and Vancomycin Effect in the Inhibition of Mutans Streptococci in Children With Dental Caries: a Randomized, Double-Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Salivary mutans streptococci levels prior to treatment, on the last day of treatment (day 6), two weeks after day 1 and 30 days after day 1.
研究概览
简要总结
The aim of the present study was to compare salivary MS levels in four different groups of children with caries, that have been submitted to intraoral topical treatment with either 1,23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin, during 6 consecutive days. This clinical trial was designed to test two different hypotheses. First, that topical vancomycin would be more effective than chlorhexidine and sodium fluoride in salivary MS reduction. Secondly, a 6-day antimicrobial treatment with either one of these agents would produce a long lasting MS suppression, dispensing repeated antibacterial treatments.
详细描述
The present study aimed to compare the effect of sodium fluoride, chlorhexidine and vancomycin on salivary mutans streptococci (MS) levels, on a double-blind, randomized clinical trial. Sixty-nine healthy volunteers, aged 4-8 years, with at least one active carious lesion and no previous history of allergies were selected to participate in the study. A gel formulation containing 1.23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin was topically administered to the dentition every 24 hours, during 6 consecutive days. Salivary MS levels were measured at baseline (D1), on the 6th (D6), 15th (D15) and 30th day (D30). For microbiological analysis, MSB agar medium was used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy children
- •Children with at least one carious cavitated or non-cavitated lesion
- •Must be able to spit
- •Must be able to collaborate during clinical intervention
排除标准
- •Children with history of allergies or allergic diseases, e.g. asthma, urticaria, rhinitis, sinusitis, or intra-oral soft tissue lesions
- •Children who underwent antibiotic treatment during the course of this clinical trial
- •Children with developmental disabilities
- •Children with no clinical signs dental caries
研究组 & 干预措施
NaF
Sodium fluoride application
干预措施: Sodium Fluoride (Drug)
V3
Topical application of 3% vancomycin
干预措施: vancomycin hydrochloride (Drug)
V10
Topical application of 10% vancomycin
干预措施: vancomycin hydrochloride (Drug)
CHX
Topical application of 1% chlorhexidine
干预措施: chlorhexidine digluconate (Drug)
结局指标
主要结局
Salivary mutans streptococci levels prior to treatment, on the last day of treatment (day 6), two weeks after day 1 and 30 days after day 1.
时间窗: 30-day observational period for each subject
次要结局
- Number of new carious lesions within the different study groups 12 months after treatment discontinuation.(one year)