Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children in Mansoura City.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Caries arrestment assessed by the International caries detection and assessment system (ICDAS) and absence of pain and signs of pulpal involvement.
研究概览
简要总结
Testing 3 different caries arresting techniques and the quality of life of a group of preschool children in Mansoura city, Egypt.
详细描述
135 preschoolers were allocated randomly into 3 groups to receive 3 techniques to evaluate caries arrestment. The first group received 38% silver diamine fluoride, the second received conventional Atraumatic restorative technique and the third group received ultra consevative treatment (UCT). The subjects were followed up at 3, 6 and 12 months to check caries activity according to the ICDAS.
The parents of the children answered the Arabic ECOHIS before treatment and after 3 months to assess oral health related quality of life.
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
- None
盲法说明
The operator must know the group in which the participant is enrolled so as to provide and carry out the intended treatment protocol. Randomization was preformed by block randomization by the nurse.
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy children aged 3-5
- •residents of mansoura city
- •having at least one carious dentine lesion
排除标准
- •large carious lesions approximating the pulp
- •signs of pulpitis, fistula, abscess.
研究组 & 干预措施
Silver diamine fluoride group
Application of 38% SDF.
干预措施: 38 % silver diamine fluoride (Drug)
Atrumatic restorative technique
干预措施: Atraumatic restorative technique (Procedure)
Ultra conservative treatment (UCT)
干预措施: Ultra conservative dentistry (Procedure)
结局指标
主要结局
Caries arrestment assessed by the International caries detection and assessment system (ICDAS) and absence of pain and signs of pulpal involvement.
时间窗: 1 year
Absence of pains and signs of pulpal involvement and caries classified as inactive by ICDAS was considered a successful outcome. When the lesions appeared shiny and felt hard on probing (for SDF and UCT). For ART success was measures by the presence of intact restoration and avsence of pain.
次要结局
- Early childhood oral health impact scale (ECOHIS)(3 months)