Phase 2 Efficacy & Safety Evaluation of Advantage Anti-Caries Varnish for Primary Prevention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Caries Increment
研究概览
简要总结
The purpose of the study is to determine the efficacy & safety of Advantage Anti-Caries Varnish for primary prevention. The objectives are:
1) To determine if Advantage Anti-Caries Varnish (test varnish) is superior to an active control varnish (5% Sodium Fluoride, no Povidone-Iodine) in the prevention of caries lesions in the primary dentition. Specifically, prevention of caries lesions in primary teeth that either are sound, have only d1 (white spots) lesions or unerupted at baseline; and 2) To document the safety of the test varnish.
详细描述
This is a single center randomized, double-blind, placebo-controlled, parallel-group trial. The treatment group will be exposed at baseline and once every three to four months after baseline for a maximum period of 24 months. The control group will be exposed to the control varnish in the same manner. 254 subjects will be enrolled. Half will be randomized to each arm. Subjects will be 6-24 mo of age and in good health. Children attending Maternal and Child Health (MCH) Immunization and Well Child programs in Pohnpei State will be enrolled. Primary Outcome Variables: 1) Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline; 2) Presence/Absence of dental caries lesions (d2-4mfs >0) at 12 months post baseline. Secondary Outcome Variable: Adverse Events
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All study personnel except for designated personnel in the data center will be blinded to the participant treatment assignment. In order to maintain blinding and eliminate examiner bias, the staff member applying these varnishes will not perform the caries scoring exams.
入排标准
- 年龄范围
- 10 Months 至 20 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject's parent or legal guardian must provide signed and dated informed consent (parent permission form).
- •The subject's parent or legal guardian of the subject must be willing and able to comply with study requirements.
- •The subject is a 6-24 months at the time of enrollment.
- •The subject must be in good general health as evidenced by parent report.
- •The subject will have at least 1 erupted tooth that is either sound or has only a d1 (white spots) lesion.
排除标准
- •Previous treatment with fluoride varnish
- •Known allergy to iodine
- •Diagnosis of thyroid disease
- •Chronic, prophylactic use of antibiotics
- •Treatment with another investigational drug or intervention within 30 days preceding the Baseline Visit.
- •Visible cavities (d2-4)
- •Presence of intraoral pathology that would make assessment of post treatment soft tissue ulcerations or inflammation impossible (child could be enrolled if problem is treated and lesions cleared)
- •Parent anticipates the child will move from Pohnpei during the next 2 years.
研究组 & 干预措施
Test Varnish
Anti-Caries Varnish. The active ingredients are 10% (w/v) Povidone-Iodine and 5% (w/v) Sodium Fluoride CAS.
干预措施: Test varnish (Drug)
Control Varnish
Control Varnish. 5% (w/v) Sodium Fluoride .
干预措施: Placebo (Drug)
结局指标
主要结局
Caries Increment
时间窗: 24 months post baseline
Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline, which is the number of surfaces at 24 months post baseline with cavitation into the enamel (d2), dentin (d3) or pulp (d4), missing due to caries (m) or filled (f).
Number of Participants With Caries, Surfaces Missing Due to Caries or Filled Surfaces
时间窗: 12 months post baseline
Presence/Absence of dental caries lesions (d2-4mfs \>0), which is defined by the presence at 12 months post baseline of 1 or more tooth surfaces with cavitation into the enamel (d2), into the dentin (d3), or into the pulp (d4), missing due to caries (m) or filled (f).
次要结局
- Adverse Events(24 months post baseline)