Clinical Effectiveness of Single-visit and Two-visit Silver Modified Atraumatic Restorative Treatment versus Conventional Restorative Treatment for Occlusal Carious Lesions in Primary Molars: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Clinically acceptable/unacceptable restorations using United State Public Health Service (USPHS) criteria
研究概览
简要总结
The aim of the study is to evaluate and compare the clinical effectiveness of single-visit and two-visit SMART with conventional HVGIC restorations for the treatment of primary molars with occlusal carious lesions over a 12-month period. The study will be conducted in the Department of Pediatric and Preventive Dentistry, MCODS Mangalore.
Children will be divided into 3 groups:
Group 1: SDF + HVGIC restoration in single visit
Group 2: SDF + HVGIC restoration in two visits
Group 3: Conventional HVGIC restoration (Positive control)
In group 1 : Entry will be gained using enamel hatchet/airotor with bur, caries excavation will be done with spoon excavator, only from the walls. SDF will be applied and HVGIC restoration will be done in the same appointment.
In group 2 : Entry will be gained using enamel hatchet/airotor with bur, caries excavation will be done with spoon excavator, only from the walls and SDF will be applied. HVGIC restoration will be done after 2 weeks.
In group 3: Caries excavation will be done using airotor and bur on the walls, spoon excavator will be used to excavate caries from the pulpal floor and HVGIC restoration will be done in the same appointment.
The restorations will be evaluated at 6 months and 12 months follow up using modified USPHS criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with carious lesion on occlusal surface of primary molar teeth with ICDAS score of 4 (with visible enamel breakdown) ICDAS score 5, and with radiolucency extending not more than middle third of dentin (RB 4) will be included.
排除标准
- •Children with systemic or mental illnesses
- •Teeth nearing exfoliation
- •Teeth with developmental defects
- •History of allergy to silver or fluoride.
- •Patients with ulceration or stomatitis.
结局指标
主要结局
Clinically acceptable/unacceptable restorations using United State Public Health Service (USPHS) criteria
时间窗: 6 months and 12 months follow up
次要结局
- Time taken for restorations and parental satisfaction regarding color of the restorations(6 months and 12 months follow up)
研究者
Dr Chaithra M
Manipal College of Dental Sciences Mangalore