The Efficiency and Gingival Health Status of Hall Versus SDF Techniques 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
- Gingival health
研究概览
简要总结
PICO question:
In Comparison to the hall technique , will silver diamine fluoride have equalvent gingival health status in treatment of carious primary molars?
population: children suffering from caries . intervention : silver diamine fluoride. comparison: hall technique outcome:
Primary outcome:
Gingival health measurement device modified gingival index, measurement unit score(0-1-2)
Secondary outcomes:
- Oral hygiene measurement device modified plaque index , measurement unit score (0-1-2)
- Time of Treatment measurement device digital chronometer, measurement unit minutes
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 . 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 method
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)
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 prevention result in managing early childhood caries ECC
干预措施: Silver diamine fluoride (Drug)
结局指标
主要结局
Gingival health
时间窗: at 6 months
Modified Gingival index (0 = no swelling 1. = mild swelling, no bleeding after gentle probing 2. = moderate to severe gingival swelling, bleeding after air drying
次要结局
- Oral hygiene(at 6 months)
- Treatment time(during procedure in the second application at 6 monthes)
研究者
Sarah Abdalla Ibrahim Abdalla
principle investigator
Cairo University