Effect of Application of Silver Diamine Fluoride (SDF) Alone Compared to SDF with Potassium Iodide on Retention of Composite Resin Restorations in Carious Primary Molars- A Randomized Clinical Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To evaluate and compare the effect of Silver Diamine fluoride alone and Silver diamine fluoride with Potassium iodide on the retention of composite resin restoration in primary molars.
研究概览
简要总结
| Recently, the use of silver modified atraumatic restorative treatment (SMART) has proved to be an effective restoration strategy for carious teeth in pediatric dentistry. This technique involves an application of Silver Diamine Fluoride (SDF) after caries excavation and restoration with a Glass Ionomer Cement (GIC). Though effective, it is not a durable option in “load bearing" molar teeth where the predominant functions are biting and chewing. The composite restorations have largely replaced GIC as the material of choice in permanent teeth. Hence, it may also be assumed that they can be a better alternative to GIC in SMART in primary molars in clinical settings. Further, composite resin is more workable and allows the operator to adapt, shape, and finish the restoration closer to its original form and function. A roadblock in complete replacement of GIC by composite in SMART is due to the micromechanical bonding of the latter to enamel and dentin which can be a concern when the carious dentin has been treated with SDF application. |
The inherent disadvantage of SDF is also due to its discoloration of teeth and margins of an esthetic restorative material. Several researchers have tried to counter this by applying a super saturated solution of potassium iodide to reduce the dark color of the dentin. This has been efficacious but can alter the properties of the dentin and bonding potential of the restorative materials.
Several in vitro studies have evaluated the effect of SDF on the bond strength of composite restorations and showed conflicting evidence. To the best of our knowledge, no clinical study has evaluated this aspect.
Hence, this study has been planned to evaluate the retention of composite resin-restoration in carious primary molars after application of SDF alone and with Potassium iodide after caries excavation, in a randomised controlled trial setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Sytemically healthy children in the age group of 4-9 years.
- •Children with Frankl behavior rating scale of positive or definitely positive
- •Asymptomatic dentinal cavitated lesions on occlusal or proximal surface in atleast one primary molars.
排除标准
- •Teeth with signs of pulpal and periapical pathology
- •Teeth with physiological mobility due to root resorption
- •Teeth with developmental defect and hypoplasia
- •Teeth having deep carious lesions with close proximity to pulp
- •Children with known allergy to silver.
结局指标
主要结局
To evaluate and compare the effect of Silver Diamine fluoride alone and Silver diamine fluoride with Potassium iodide on the retention of composite resin restoration in primary molars.
时间窗: At 6 months and 12 months
次要结局
- To evaluate the effect of Silver Diamine Fluoride with and without Potassium Iodide on arrest of secondary caries.(at 6 months and 12 months)
- To assess the discoloration on the composite resin restoration after application of Silver diamine fluoride with and without potassium iodide.(at 6 months and 12 months.)
研究者
Dr Amna Afrin Kidwai
AIIMS, New Delhi