Clinical Effectiveness of Silver Modified Atraumatic Restoration with Potassium Iodide Application versus Atraumatic Restorative Treatment for Treating Occlusal Caries in Primary Molars – A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 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
TheAim of the study is toevaluate the clinical effectiveness of high viscosity glass ionomerrestorations placed using conventional Atraumatic Restorative Treatment technique(ART) when combined with Silver Diamine Fluoride and Potassium Iodide application(SDF+KI) in primary molars with dentinal carious lesions on the occlusalsurfaces. The time period of the study is 18 months. The study will beconducted in the Department of Pediatric and Preventive Dentistry, MCODSMangalore.
Children will be dividedinto 2 groups:
Group 1: High ViscosityGlass Ionomer Cement (GC Fuji IX)- Control group
Group 2: Silver DiamineFluoride with Potassium Iodide (SDF+KI) + GC Fuji IX GP with ART technique
Caries excavation will bedone using spoon excavator. In group 1, caries excavation and restoration willbe done following the conventional ART technique. In group 2, caries excavationwill be done only from the walls. SDF +KI application will be done in accordance with manufacturer’s instructionsfollowed by placement of the restorative material according to the conventionalART technique.
USPHS criteria will beused for evaluating the restorations at 6 months and 12 months follow up.
A comparison of the timetaken for restoration and parental satisfaction regarding the colour of therestoration between the two groups will be the secondary objectives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Not Applicable
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 the occlusal surface of primary molar teeth that are active(dentin feels soft or leathery on gentle probing) with ICDAS score of 4 with visible enamel breakdown, ICDAS score 5 and ICDAS score 6 (wide cavities extending to more than half occlusal surface) with radiolucency extending not more than middle third ofdentin (RB 4) will be included.
排除标准
- •Children with systemic and mental illnesses.
- •Tooth with deep carious lesion, involving the pulp.
- •Radiographic evidence of pulpal involvement, periapical pathology.
- •Teeth nearing the exfoliation time.
结局指标
主要结局
Clinically acceptable/unacceptable restorations using United State Public Health Service (USPHS) criteria.
时间窗: The restorations will be evaluated at 6 months & 12 months follow up
次要结局
- A comparison of the time taken for restoration & parental satisfaction regarding the color of the restoration between the conventional ART and SMART restoration with KI application(The restorations will be evaluated at 6 months & 12 months follow up.)