Medical Management of Caries in the Primary Dentition Using Silver Nitrate: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Change in baseline Caries Experience and activity (Incidence of caries in primary teeth)
研究概览
简要总结
This pilot trial compares conventional restorations with a new strategy based on the medical management of caries using silver nitrate and fluoride varnish with no restorations.
详细描述
This is a two-arm, parallel group, patient-randomized controlled pilot trial. Children with at least one primary tooth where caries extends into dentine. Children will be randomized and treated according to one of two treatment approaches;(1) conventional caries management with best practice prevention, or (2) medical management of caries using silver nitrate with best practice prevention.
Baseline measures and outcome data (at treatment/review during two year follow-up) are assessed through direct reporting, clinical examination including blinded radiographic assessment, and child/parent questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
the radiographic progression of caries is assessed by a masked investigator
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presense of one or more cavitated carious lesions in the primary dentition, extending into dentin but not encroaching on the pulp.
- •Absense of any spontaneous or elicited pain due to caries, or signs of pulpal infection in response to any of the carious lesions in the primary dentition to be included in the study
排除标准
- •Hereditary developmental defects of the teeth such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
- •Medical conditions that prevent treatment of the child in the outpatient clinic. These conditions include severe bleeding disorders, cardiac problems and mental disabilities that prevent child from communication with the research team.
- •Known allergy/sensitivity to any of the dental materials.
研究组 & 干预措施
conventional treatment group
The child will receive a prophylaxis and fluoride varnish. Parents will fill out a parent and a child questionnaire.
干预措施: Prophylaxis (Procedure)
conventional treatment group
The child will receive a prophylaxis and fluoride varnish. Parents will fill out a parent and a child questionnaire.
干预措施: Fluoride varnish (Drug)
Silver Nitrate group
The child will receive a prophylaxis, then silver nitrate and then fluoride varnish. Parents will fill out a parent and a child questionnaire.
干预措施: Prophylaxis (Procedure)
Silver Nitrate group
The child will receive a prophylaxis, then silver nitrate and then fluoride varnish. Parents will fill out a parent and a child questionnaire.
干预措施: Fluoride varnish (Drug)
Silver Nitrate group
The child will receive a prophylaxis, then silver nitrate and then fluoride varnish. Parents will fill out a parent and a child questionnaire.
干预措施: Silver Nitrate (Drug)
结局指标
主要结局
Change in baseline Caries Experience and activity (Incidence of caries in primary teeth)
时间窗: through study completion, for 2 years
Detailed measurements of caries experience will be recorded at baseline and annual caries examination using EC4
次要结局
- Caries activity in primary teeth(through study completion, for 2 years)
研究者
Arwa Owais
Principal Investigator
University of Iowa