Comparison of survivability, cost effectiveness, and oral health quality of life of SMART & ART in restoration of primary molars-A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Survival rates: compare the effectiveness of Silver Modified Atraumatic Restorative Treatment and Atraumatic Restorative Treatment in treatment of dental caries in a school setting.
研究概览
简要总结
The title of the study "Comparison of Survival, Cost Effectiveness, and Oral Health Quality of Life of Silver Modified Atraumatic Restoration Treatment & Atraumatic Restorative Treatment in Restoration of Primary Molars—A Randomized Controlled Trial" focuses on evaluating two minimally invasive dental treatments: Silver Modified Atraumatic Restorative Treatment (SMART) and Atraumatic Restorative Treatment (ART). The study aims to compare their effectiveness, cost-efficiency, and impact on Oral Health-Related Quality of Life (OHRQoL) in children aged 6 to 11 with carious primary molars. It employs a randomized controlled trial involving 130 lesions, assessing outcomes like survival rates of restorations, treatment costs, and the time required for each procedure. The results are intended to inform more cost-effective and patient-friendly approaches to managing childhood dental caries, with a particular focus on outreach settings to reduce healthcare costs while improving oral health outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 11.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with at least one carious lesion as defined by the Nyvad’s caries criteria 3 without pulp involvement for caries lesion activity and severity assessment.
- •Children with informed consent from parents.
排除标准
- •Children younger than 6 years and older than 11 years.
- •Children whose parents denied consent.
- •Uncooperative children.
- •Medically compromised patients Children with spontaneous or elicited pain from caries, tooth mobility or signs of pulpal infections.
结局指标
主要结局
Survival rates: compare the effectiveness of Silver Modified Atraumatic Restorative Treatment and Atraumatic Restorative Treatment in treatment of dental caries in a school setting.
时间窗: 9 months
Cost-effectiveness: assess the cost effectiveness of Silver Modified Atraumatic Restorative Treatment and Atraumatic Restorative Treatment restorations in primary molars.
时间窗: 9 months
次要结局
- Time duration of procedure(Oral Health Quality of Life)
研究者
Dr Dharmashree Satyarup
Institute of Dental Sciences, Siksha O Anusandhan(deemed to be university), Bhubaneswar