Phase 2 Efficacy Evaluation Of Advantage Anti-Caries Varnish
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Dental Caries for All Primary Teeth Sound at Baseline
研究概览
简要总结
The purpose of the study is to determine the efficacy of Advantage Anti-Caries Varnish. Single-center, double-blind, controlled Phase 2 study with parallel groups of children. Subjects will be stratified by early childhood education center and then randomized to receive either test varnish or control varnish topically to the teeth. Treatment will be administered quarterly for up to 24 months. The primary outcome is surface-level primary molar caries increment (d2-4mfs) at 24- months post baseline.
详细描述
Objectives:
Primary
- To determine if Advantage Anti-Caries Varnish (test varnish) is superior to a control varnish containing only fluoride in the prevention of new caries lesions.
Secondary
- To establish that the response of child participants to the test varnish was not inferior to the control varnish
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, the caries scoring examinations will precede the application of test varnishes at baseline. The staff member applying these varnishes will not perform the caries scoring exams in order to eliminate examiner bias and ensure blinding to treatment assignment. Test drug and comparator are packaged identically.
入排标准
- 年龄范围
- 60 Months 至 84 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
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 aged 60-84 months at the time of enrollment.
- •The subject must be in good general health as evidenced by parent report.
排除标准
- •Known allergy to iodine
- •Known allergy to seafood
- •Known hypersensitivity to fluoride varnish
- •Diagnosis of thyroid disease
- •Chronic, prophylactic use of antibiotics
- •Treatment with another investigational drug or other intervention within 30 days preceding the Baseline Visit.
研究组 & 干预措施
Test varnish
Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride .
干预措施: Test varnish (Drug)
Standard varnish
The active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine.
干预措施: Standard varnish (Drug)
结局指标
主要结局
Dental Caries for All Primary Teeth Sound at Baseline
时间窗: 24 months
The outcome will be the surface-level primary tooth caries increment (d2-4mfs) at two years post baseline that were sound at baseline. Caries, as measured by d2-4mfs, is the total number of surfaces with decay into the enamel (2), dentin (3) or pulp (4), missing due to caries (m), or filled with amalgam, composite or other filling material (f). This scale records whether caries is detected in any of the 4 or 5 surfaces of the tooth for up to 20 primary teeth that were sound at baseline, and has a range of 0 to 88. Higher values indicate a greater number of caries. The measure records whether caries is present on any of the 5 surfaces of the primary molars or 4 surfaces of the other teeth.
Dental Caries for Primary Molars Sound at Baseline
时间窗: 24 months
The primary outcome will be the surface-level primary molar caries increment (d2-4mfs) at two years post baseline. Caries, as measured by d2-4mfs, is the total number of surfaces with decay into the enamel (2), dentin (3) or pulp (4), missing due to caries (m), or filled with amalgam, composite or other filling material (f). This scale records whether caries is detected in any of the 5 surfaces of the tooth for up to 8 primary molar teeth that were sound at baseline, and has a range of 0 to 40. Higher values indicate a greater number of caries.
次要结局
- Child Response to Fifth Treatment(After fifth treatment visit)
- Child Response to First Treatment(After first treatment visit)