Sequential Application of PVP-I and Fluoride Varnish: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 393
- 主要终点
- Surface level caries
研究概览
简要总结
This prospective cohort study in children will determine if: topical povidone iodine 10% followed by topical fluoride varnish is superior to placebo iodine followed two different varnishes alone to prevent tooth decay (dental caries).
详细描述
Primary Objectives:
- To determine if sequential topical application of Povidone Iodine (Povi-One, 10% PVP-I) followed by the Fluoride Varnish (Fluorimax, 2.5% NaF) every 3 months is superior to an active control (placebo + standard of care FV (Fluorimax) at 24 months post baseline. Specifically, prevention of caries lesions in primary teeth that either are sound, have only d1 (white spots) lesions or unerupted at baseline.
- To determine if the sequential topical application of Povidone Iodine (Povi-One, 10% PVP-I) followed by the Fluoride Varnish (Fluorimax, 2.5% NaF) every 3 months is superior to active control (placebo + ClinPro Clear Fluoride Treatment (Solventum, 2.1% NaF) at 24 months post baseline. Specifically, prevention of caries lesions in primary teeth that either are sound, have only d1 (white spots) lesions or unerupted at baseline.
Secondary Objective:
To determine if sequential topical application of placebo followed by the Fluoride Varnish (Fluorimax, 2.5% NaF) every 3 months is superior to placebo followed by Clinpro Clear Fluoride Treatment (Solventum, 2.1% NaF) at 24 months post baseline.
Study Design: Open label prospective cohort study. The study will be conducted in two hospitals in Puno serving the "Control de Crecimiento y Desarrollo (CRED)" program, conducted under the Ministry of Health. The treatment at each site will be the same with different treatments on different days of the week chosen randomly, stratified by hospital. There will be no individual randomization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children 6-24 months of age at enrollment. To be eligible a child will have at least 1 erupted tooth that is either sound or has only a d1 (white spot) 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 other intervention within 30 days preceding the Baseline Visit.
- •Visible cavities (d2-4) in the erupted primary teeth
- •Presence of intraoral soft tissue pathology (gum boil)
- •Parent anticipates the child will move from current city during the next 24 months.
结局指标
主要结局
Surface level caries
时间窗: 24 months
d2-4mfs
次要结局
- Presence/Absence of dental caries lesions(24 months)
研究者
Peter Milgrom
Investigator
Advantage Silver Dental Arrest, LLC