Efficacy and Cost-effectiveness of Different Caries Preventive Protocols in a High -Risk Group of Young Egyptian Adults: A Randomized Control Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 主要终点
- Caries increment
研究概览
简要总结
To compare the caries preventive efficacy of clinical-based, home based or E-based oral health interventions and their cost effectiveness.
详细描述
Caries risk assessment and preventive measures have been performed over years with different perspectives without attention to budgeting and economic value and the preventive protocols remain uncertain for adults.
caries prevention, for example using fluoride varnish, has been found only limitedly cost-effective in clinic settings, which is why alternative strategies involving home-based interventions are sought .Electronic health (E-health) interventions for patient motivation and enhancing of patient adherence, for example via reminders about the reinforcement of hygiene measures and dietary counseling as well as recall visits were found to be of value This randomized controlled clinical study aims to compare the caries preventive efficacy of clinical-based, home based or E-based oral health interventions and their cost effectiveness
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
assessors will unaware of the treatment assigned to the patients therefore the assessors will not be included in the pre clinical assessment.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •High caries risk patients.
- •18-25years.
- •Males or females.
- •Participants approving to enrol in this study.
- •Participants not enrolled in any other study.
排除标准
- •low or moderate caries risk
- •Participants with systematic conditions.
- •Patients younger than 18 years.
- •Evidence of parafunctional habits.
- •with developmental dental anomalies.
- •undergoing or will start orthodontic treatment.
- •with removable prosthesis
研究组 & 干预措施
Clinical-based preventive platform
applying of Fluoride varnish every 3 months
干预措施: Fluoride based varnish (Dentkist Charm Fill Varnish ) (Drug)
Home-based preventive platform
topical remineralizing agent
干预措施: pro care gel remineralizing agent (Drug)
E health platform
Mobile application
干预措施: Mobile application (Device)
Basic preventive measures
tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning, fluoride rinse OTC
干预措施: tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning,fluoride rinse OTC (Combination Product)
结局指标
主要结局
Caries increment
时间窗: 12 moths
number of carious tooth surfaces will be calculated ( DMFS score)will be monitored and recorded separately.
次要结局
- Cost-Effectiveness(12 months)
研究者
Roya mohamed Hamad Elmaghrbi
doctor
Cairo University