Comparison of light cured silver diamine fluoride with Silver Diamine Fluoride- Potassium iodide on arresting carious lesions in primary teeth: 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
- 38
- 试验地点
- 1
- 主要终点
- To evaluate caries arrest rate, clinical success, radiographic success and parental acceptance of
研究概览
简要总结
Patients will be recruited from the outpatient settings of Department of Dentistry (Unit of Pediatric and Preventive Dentistry), University college of Medical Sciences and GTB Hospital.
All healthy children having carious primary molars in mandibular arch, indicated for restoration satisfying inclusion and exclusion criteria will be included in the study .
Caries arrest rate will be recorded over a period of 3 months, 6 months and 9 months.
Clinical success will be recorded at 3 months, 6 months and 9 months.
Radiographic success will be recorded at 3 months, 6 months and 9 months.
Parental acceptance for ease of application, discolouration, pain related to application and discomfort in taste will be recorded using 5 point Likert Scale with scoring being strongly agree, agree, neutral, disagree, strongly disagree will be recorded post treatment and after 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy and cooperative children.
- •Children of age group 4-7 years with atleast one active carious lesion bilaterally in a primary mandibular molar with score 4 or 5 (asymptomatic dentinal caries) according to the International Caries Detection And Assessment System- ICDAS II detected using visual and tactile inspection to assess lesion severity and activity and RA 3 according to ICCMS TM.
- •Teeth with no signs of pulpal involvement.
- •Teeth with no signs of pain, abscess, fistula.
- •Teeth with no premature hypermobility.
- •Teeth with no internal or external root resorption.
- •Teeth with atleast two third of the root length remaining.
排除标准
- •Teeth that caused spontaneous pain or showed signs of pulpal infection, swelling and or/abscess.
- •Children with history of major systemic disorders.
- •Children with allergy to silver or any materials used in the study.
- •Children with intellectual disability.
结局指标
主要结局
To evaluate caries arrest rate, clinical success, radiographic success and parental acceptance of
时间窗: Follow up at 3 months, 6 months and 9 months.
a.Light cured silver diamine fluoride
时间窗: Follow up at 3 months, 6 months and 9 months.
b.Silver diamine fluoride with potassium iodide .
时间窗: Follow up at 3 months, 6 months and 9 months.
次要结局
- To evaluate the parental satisfaction of sdf and light cured sdf(9 months)
研究者
Chithaluru Pranathi
University College of medical Sciences Delhi