Nobio Antimicrobial Particles Effect in a Split Mouth Model
试验速览
- 阶段
- 不适用
- 发起方
- Nobio Ltd.
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Occurrence and severity of adverse events related to dental care
研究概览
简要总结
The study purpose is to evaluate the antimicrobial effect of Nobio particles incorporated within Novidia Dental Bonding and Flowable Composite versus standard of care within a split mouth model.The study population will include 35 subjects considered to be at high risk for cervical caries and affected by uncontrolled plaque accumulation
详细描述
An exploratory, comparative, self-controlled single blinded interventional study. Intended to evaluate the antimicrobial effect of Nobio particles incorporated within Novidia Dental Bonding and Flowable composite versus Filtek bond and flow composite within a split mouth model.The study population (N=35) will be high risk population for cervical caries (with at least 2 carious cavities in the mouth) affected by uncontrolled plaque accumulation.Each subject will serve in this model as his own control.On one side the Novidia intervention will be made and on the contralateral side the Filtek intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over 18 years of age.
- •Requires two cervical restorations or the exchange of existing ones
- •Subject has poor oral hygiene and at high risk for plaque accumulation.
- •Subject able and willing to comply with study visits and Follow up visits and signed the informed consent.
排除标准
- •Allergic reaction to iodide.
- •Pregnant or lactating women.
- •Use of antiseptic mouth rinse or antibiotic up to 2 weeks before the beginning of study.
- •Exclusion criteria for the chosen teeth for the study:
- •Tooth designated for extraction in the following 6 month.
- •Tooth designated to have a root canal treatment.
- •Tooth or several teeth designated for periodontal surgery.
研究组 & 干预措施
Novidia Dental bonding and flow
Nobio particles incorporated within Novidia Dental Bonding and Flow.
干预措施: Nobio particles incorporated within Novidia Dental Bonding (Device)
Filtek bond and flow composite
standard of care class V composite restoration performed with Filtek and 3M
干预措施: Filtek bond and flow composite (Device)
结局指标
主要结局
Occurrence and severity of adverse events related to dental care
时间窗: one year
Record unanticipated adverse device-related events (UADE),Incidence and nature of serious adverse events (SAE). Incidence and nature of adverse events
次要结局
- Subject and Dentist satisfaction questionnaire(one year)
- Plaque index rate(one year)
- Replica method for bacterial count(one year)
- Physician assessment of cervical restoration integrity(one year)
- Dead/Live Staining of biofilm (Cyto 9)(one year)