Comparison of Six Months Retention of Bonded Amalgam Sealants Versus Resin-based Sealants: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Retention of sealant
研究概览
简要总结
Dental caries, is one of the major public health problem in Pakistan. Dental sealants are known cost effective preventive measure of dental caries as compared to other preventive measures. Resin based sealants, is a proven treatment of pits and fissure sealants but retention is still problem. This trial will assess the use of amalgam sealants as an effective and retentive preventive measure in preventing dental caries in children as compared to the standard resin-based sealants. The findings of this randomized controlled trial will be used to raise awareness among the health care professionals, help them to choose amalgam sealants as an effective caries prevention method thereby reducing the burden of cost as amalgam is cheaper material compared to resin-based sealants.
The research question Is there any difference in the six months retention of bonded amalgam sealants compared to resin-based sealants among 12 to 16 years old children in Karachi
详细描述
Objective:
To compare the six month retention of bonded amalgam sealants with that of resin-based sealants among 12 to 16 year old children in Karachi
Methods:
The study design will be parallel group, equivalence randomized controlled trial. Aim is to determine the equality of the Amalgam sealants retention compared to resin based sealants retention.
Outcome:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of aged 12 to 16 years (male and female) who will visit to the study site and fulfilled the eligibility criteria
- •Teeth should be caries free at the time of sealants placement. As Dental sealant is a preventive treatment it is placed in a caries free surface. Incipient carious lesions will also be included.
- •Teeth should be completely erupted, as incomplete eruption of teeth is highly correlates to the partial retention of sealants.
- •Children who will give assent to participate in a study and their parents will give consent.
排除标准
- •Special needs children (because they need special attention of parents)
- •Children who have blood disorder like (leukemia, lymphoma, and thalassemia)
- •Persons with impaired vision, speech and hearing (because either they may not be able to respond to questionnaire or conducting baseline dental training will be difficult).
结局指标
主要结局
Retention of sealant
时间窗: Six months
1. Complete retention, if the all the occlusal fissures were covered by the sealant. 2. Partial retention, if some of occlusal fissures of a tooth showed loss of sealant. 3. Complete failure, if sealant was missing from all the occlusal fissure of the tooth.
次要结局
未报告次要终点
研究者
Farhan Raza Khan
Assistant Professor
Aga Khan University