Evaluation of antimicrobial efficacy of Tubulicid, a cavity disinfectant against S.mutans in primary teeth: An in vivo study.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tubulicid may have better antimicrobial property against steptococcus mutans by evaluating under colony counter in the sample collected from the cavity after application of cavity disinfectant for 60 seconds
研究概览
简要总结
An interventional, double-blinded, the randomized parallel-group will be conducted in 60 primary teeth of 4 to 10 years old children who have class 1 dental caries, after obtaining the written informed consent from the parents of the child 60 primary teeth requiring restoration will be divided into two groups using the lottery method. Group I (n=30 teeth)Chlorohexidine as cavity disinfectant, Group II (n=30 teeth): Tubulicid Red as cavity disinfectant. The tooth will be isolated with a rubber dam and the carious dentin will be excavated using a spoon excavator. Based on color, consistency the infected dentin will be removed, affected dentin will be leftover. Then the dentinal sample will be collected from the base of the cavity using a sterile spoon excavator before and after application of the disinfecting agents for 60 sec. After rinsing with saline, the cavity is restored with either GIC or composite material. The collected dentinal sample will be transferred into Eppendorf tubes containing 0.5ml of phosphate buffer solutions. Two microliters of the samples collected before and after disinfection will be inoculated on the mutans sanguis (MS) agar (M997; Himedia, India) a selective medium for Streptococcus mutans (MS). The plates will be incubated for 72 hrs in an atmosphere containing 5% Co2 and 95% N2 at 37°C. Colony forming units on the plates will be counted using the colony counter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 4.00 Year(s) 至 10.00 Year(s)(—)
- 性别
- All
入选标准
- •Carious primary teeth involving till 2/3 rd of dentin No clinical and radiographic signs of pulpal involvement.
排除标准
- •Patients who had received antibiotics up to 2 weeks prior to the sampling or having any systemic compromise Patients who had non-restorable teeth perforated pulpal floor excessive mobility or pathological root resorption or caries involving the pulp.
结局指标
主要结局
Tubulicid may have better antimicrobial property against steptococcus mutans by evaluating under colony counter in the sample collected from the cavity after application of cavity disinfectant for 60 seconds
时间窗: 60seconds
次要结局
- Chlorhexidine may have better antimicrobial property against streptococcus mutans by evaluating under colony counter in the sample collected from the cavity after application of chlorhexidine for 60 seconds(60 seconds)
