Evaluation Of Changes in Children's Oral Health-Related Quality of Life Following Treatment of Early Childhood Caries With Caries Arrest Technique Using Silver Diamine Fluoride Versus Conventional Drill and Fill Technique A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Oral Health to Quality of Life
研究概览
简要总结
The clinical trial aims to compare children's oral health-related quality of life (OHrQL) following caries arrest technique using SDF versus conventional drill and fill in the children with ECC
详细描述
Early childhood caries (ECC) has been an increasing issue in many countries and has become a significant health problem, especially in socially disadvantaged populations. ECC is a specific form of caries that occurs in children with primary teeth. ECC is characterized as "the early onset of caries in young children with often fast progression which can finally result in complete destruction of the primary dentition".
Management of cavitated carious lesions in primary teeth in very young children is time-consuming due to their lack of cooperation, so one of the alternative procedures could be performed with silver diamine fluoride (SDF), to its effectiveness in arresting the activity of carious lesions (cavitated and non-cavitated). It is easy to apply even outside dental offices, and relatively inexpensive solutions can be used particularly when compared to restorative intervention.
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
- Double (Participant, Outcomes Assessor)
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
- •Children Aged 3 to 5 years, in good general health and medically within normal.
- •The parents provided written informed consent.
- •Carious vital primary molars with reversible pulpitis.
- •Restorable teeth.
- •Normal Radiographic findings.
排除标准
- •Unable to attend follow-up visits.
- •Refusal of participation.
- •Previously accessed teeth.
结局指标
主要结局
Oral Health to Quality of Life
时间窗: 6 month intervene
will be evaluated by a questioner answered by the parents
次要结局
- Side effects(6 month intervene)
- Parental satisfaction(6 month intervene)
- Time of the procedure(6 month intervene)
- Postoperative pain and sensitivity(6 month intervene)
- The cost effectiveness(6 month intervene)
研究者
Gala Sharif Osman
principal investigator
Cairo University
