EFFECT OF SILVER DIAMINE FLUORIDE ON STREPTOCOCCUS MUTANS COLONIZATION IN CHILDREN WITH EARLY CHILDHOOD CARIES – A REAL TIME PCR STUDY
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Black stains on the SDF applied tooth surface, This hardened surface indicates of arrest of caries
研究概览
简要总结
This study is randomized parallel group trial comparing the effect of silver diamine fluoride on streptococcus mutans in saliva sample of children with early childhood caries in 1 month period of time. 30 patients with early childhood caries are taken. Each child will be examined for carious status using international caries detection and assessment system. Teeth which received ICDAS score 5 or 6 are selected. Pre treatment unstimulated saliva samples are taken as follows paper point is dipped in saliva for 30 seconds in the floor of the mouth. Silver diamine fluoride procedure will be carried out as per manufacture instruction, post treatment unstimulated saliva samples will be collected at 24hrs and during follow up at 1 month. All the above samples will be transferred aseptically and sent for microbial analysis. The primary outcome will be change of SDF treated tooth color to black stain which indicates of hardened dentin surface. The secondary outcome will be the effect of SDF on inhibition of streptococcus mutans colonization using real time PCR study
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant, Investigator and Outcome Assessor 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 aged between 3-6 years from either gender.
- •Early Childhood Caries with active dentinal carious lesion in children.
- •At least one tooth with soft cavitated dentine surfaces received scores 5 (Distinct cavitation with visible dentin, involving less than half of a tooth surface) or 6 (Extensive cavitation with visible dentin, where the cavity is wide involving more than half of a tooth surface) of the ICDAS criteria.
排除标准
- •Children who received fluoride topical application during last 48 hours.
- •Children with special health care needs.
- •Tooth with an abscess, symptoms of irreversible pulpitis, or a mobile tooth.
- •Children who were on antibiotic therapy within past 3 months.
- •Children with known sensitivity to silver or other heavy-metal ion were excluded.
结局指标
主要结局
Black stains on the SDF applied tooth surface, This hardened surface indicates of arrest of caries
时间窗: After one month SDF applied tooth surface is checked for black stains, this hardened surface indicates of arrest of caries
次要结局
- EFFECT OF SDF ON INHIBITION OF STREPTOCOCCUS MUTANS COLONIZATION USING REAL TIME PCR STUDY(1 day and 1 MONTH)