NANO SILVER FLUORIDE USED IN CARIES ARREST EVALUATED WITH AND WITHOUT RESTORATION IN CHILDREN - A PROSPECTIVE STUDY
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To determine and compare the caries incidence across study arms over time
研究概览
简要总结
This is a prospective study to determine the compare the caries incidence and caries pattern with and without restoration after the application of Nano silver fluoride(NSF).An aseptic protocol will be carried out throughout the procedure. Clinical examination of children will be performed using plain mirror and explorer on the dental chair with optimal light. Activity of cavitated dentinal caries lesion will be assessed by visual inspection and aided by tactile detection using an explorer. Each child will be examined for carious status using International Caries Detection and Assessment System (ICDAS).
After clinical examination, subjects fulfilling the selection criteria will be randomly divided into two groups, Group A (n=20) Group B (n=20). NSF application will be carried out in both groups & GIC restoration of treated occlusal lesions in group B, dietary and oral hygiene instructions will be given to all children.
NSF application procedure is as follows:
All the study participants will be subjected to thorough oral prophylaxis, no effort would be done to remove the caries or unsupported enamel followed by cotton roll isolation and initial cleaning of the cavity to be performed by using small cotton pellet, tooth with active caries lesion will receive two drops of NSF with an applicator tip and the same tip is applied across all the tooth surfaces & discarded after single use. Application time is 2 minutes. Excess NSF is to be removed with cotton pellet to minimize systemic ingestion.
Clinical examination of all the subject subjects will be done over a period of 6 months to ascertain any change in the dmfs index, caries pattern, retention of GIC cement, any adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 6.00 Year(s)(—)
- 性别
- All
入选标准
- •Children of 3-6 years of age from either gender.
- •Atleast one tooth with soft cavitated dentine surfaces received scores 5 (Distinct cavitation with visible dentin, involving less than half of a tooth surface) of the ICDAS criteria.
排除标准
- •Children who received topical fluoride application during the last 3 months
- •children with special health care needs
- •Tooth with symptoms of irreversible pulpitis
- •Children with known sensitivity to silver or other heavy metal ion
- •Hypoplastic or developmental defects.
结局指标
主要结局
To determine and compare the caries incidence across study arms over time
时间窗: Baseline and 6 months after the intervention
次要结局
- To determine and compare the caries pattern across study arms over time(Baseline and 6 months after the intervention)
研究者
Dr Berin Dhanya N B
Rajarajeswari Dental College and Hospital
