"Parental Perception and Acceptance of the Utilization of Silver Diamine Fluoride on Their Child's Anterior and Posterior Teeth Before and After Masking the Colour With Glass Ionomer"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Assessement of Parental perception and Acceptance
研究概览
简要总结
Assessing Parents acceptance for the colour of Silver Diamine Fluoride on their Children anterior and posterior teeth before and after masking its colour with Glass Ionomer.
详细描述
Sample size estimation Sample size estimation was based on the primary outcome of interest The final sample size was 41 children per group (total sample size = 82 children)
Patients will be recruited randomly from outpatient clinic of the Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Ain Shams University. A signed informed consent to the parents' and also an insent to child,outlined by the Ethical Committee, Faculty of Dentistry, Ain Shams University will be obtained before the conduction of the study.
All examination procedures will be done by the same operator to ensure standardization.
Moreover, all patients will receive oral health education in regard to dietary and oral hygiene habits.
Excluded carious primary molars will be scheduled to receive the appropriate treatment.
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, Investigator)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Uncooperative patients.
- •Patients whom their parents refuse or cannot afford the cost of GA surgeries.
- •Teeth that are restorable with restoration and doesn't need full coverage.
- •Teeth which are free of symptoms of pulpal pathology.
- •Children with anterior and posterior carious teeth with minimum of two teeth.
排除标准
- •Patients whom their parents totally refuse Silver diamine fluoride staining .
- •Children suffering from any medical condition that can't be managed in the clinic.
- •Children with known allergies to silver products.
- •Children with severe forms of hypoplasia .
研究组 & 干预措施
group B
-38% Silver diamine fluoride will be applied by the same protocol as in group A
Then Glass Ionomer restoration is applied as follows
- Self cure glass ionomer restoration is applied not light cured as light causes oxidation of silver and the filling appears darker.
- Glass ionomer won't be applied immediately after SDF placement it will be applied at time ranging from 2 hours to two days.
- Conditioning of the base of the cavity is done by 3M ESPE conditioner for 10 seconds then rinsing the cavity for 10 to 20 secs.
- Applying High strength hand mix chemical self cure glass ionomer.
干预措施: Silver diamine fluoride and glass ionomer (Procedure)
group A
- 38% Silver diamine fluoride will be applied to carious lesions by microbrush on the affected surface application time should be 1 min, Application time will be shorter in very young patients.
干预措施: Silver diamine fluoride (Procedure)
结局指标
主要结局
Assessement of Parental perception and Acceptance
时间窗: december 2019 to june 2021
Assessement of Parental Perception and Acceptance of the Utilization of Silver Diamine Fluoride on their Child's Anterior and Posterior Teeth before and after masking the colour with Glass Ionomer through 5 point likert scale The format of the five-level Likert scale will be 1. Strongly disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly agree
次要结局
- protocol for placement of silver diamine fluoride with minimal staining(december 2019 to june 2021)
研究者
Dina Bassam Mohamed Ahmed
Dina Bassam Mohamed Ahmed
Ain Shams University