Post-operative Pain and Child Behavior of Hall Technique Versus Silver Diamine Fluoride in the Management of Carious Primary Molars: Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 40
- 主要终点
- post-operative pain
研究概览
简要总结
PICO question:
Papulation: children suffering from caries Intervention: Silver Diamine Fluoride Comparison: Hall technique
Outcome:
Primary Outcome: Intraoperative and postoperative pain Measurement device: Face pain scale Revised8 Measurement unit: Score 0-2-4-6-8-10
Secondary Outcome:
- Child Anxiety Measurement device: Venham Anxiety rating scale 9 Measurement unit: Six-point scales 0-1-2-3-4-5
- Child Behavior Measurement device: Venham Behavior rating scale 9 Measurement unit: Six-point scales 0-1-2-3-4-5
详细描述
Dental caries, also known as tooth decay, it can occur in primary teeth in early childhood, is formed through interaction between acid-producing bacteria and carbohydrate. The caries develops in both the crowns and roots of teeth. Progress of caries depended on the lifestyle of the child (as high numbers of cariogenic bacteria, inadequate salivary flow, insufficient fluoride exposure and poor oral hygiene). To avoid this disease should follow the proper oral hygiene and improve lifestyle 1. A lot of methods found to treatment the decayed tooth - like; Hall technique and Silver diamine fluoride.
The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method2.
Previous studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC) 3
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)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: From 4 to 6 years
- •Clinical diagnosis of tooth with caries in primary molars within enamel or dentin without pulp disease
排除标准
- •Tooth with signs and symptoms of pulp necrosis
- •Tooth with Root caries
- •Tooth with Spontaneous pain
研究组 & 干预措施
control group
The group that have caries in primary molars and treat them with Hall Technique
干预措施: Hall Technique (Device)
experimental group
The group that have caries in primary molars and treat them with Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC.
干预措施: Silver diamine fluoride (Drug)
结局指标
主要结局
post-operative pain
时间窗: at 6 months
Face Pain Scale Revised Immediately after the treatment, any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R). Each child was asked to mark the face that reflected her or his experienced pain during the treatment. The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.
次要结局
- Child Anxiety(Immediately)
- Child behavior(Immediately)
- Intra operative pain(Immediately)
研究者
Noura Mohamed Alhosaini
Principal Investigator
Cairo University