Evaluation of anti-microbial efficacy of 3.8% silver diamine fluoride as root canal irrigant against Enterococcus faecalis in primary teeth: An in vivo study.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Silver diamine fluoride may have better antimicrobial
研究概览
简要总结
An interventional, double-blinded, randomized parallel-group trial will be conducted in 60 teeth from the patients requiring pulpectomy of 3 to 8 years old after obtaining written informed consent from the parents of the child. 60 teeth requiring pulpectomy will be divided into two groups using the following irrigants: Group I (n=30 teeth): 2% Chlorhexidine gluconate and Group II (n=30 teeth): 3.8% Silver diamine fluoride. Appropriate local anesthesia will be given and the tooth will be isolated with a rubber dam. The gross carious tissue will be removed and initial access opening will be done with No. 3 round carbide bur. Working length will be determined with a preoperative intraoral periapical radiograph. The first microbiological sample will be obtained with 2 sterile absorbent paper points each for 30 seconds from the root canal (pre irrigation) and will be immediately immersed into a test tube with Brain Heart Infusion Broth (BHI). Conventional biomechanical preparation will be done up to 35 k-file. During instrumentation after each file, Group I: 0.5 ml of 2% Chlorhexidine gluconate for 5 seconds will be used as an irrigant and Group II: 0.5 ml of 3.8% Silver diamine fluoride for 5 seconds will be used as an irrigant. Final irrigation of canals will be done at the end of instrumentation and dried before obturating and a second microbiological sample will be collected with another 2 sterile absorbent paper points each for 30 seconds. The root canal will be filled with an obturating material and a postoperative intraoral periapical radiograph will be taken. The collected samples will be subjected to microbiological analysis to determine the number of colony-forming units against E. faecalis. The obtained results will be subjected to statistical analysis.
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
- 3.00 Year(s) 至 8.00 Year(s)(—)
- 性别
- All
入选标准
- •Primary teeth of maxillary or mandibular, anterior/posterior containing at least one necrotic pulp canal, abscess, or sinus tract.
- •Presence of radiolucent area in furcation or periapical region.
- •At least two-thirds of the root remains.
- •Sufficient tooth structure to support a rubber dam.
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.
结局指标
主要结局
Silver diamine fluoride may have better antimicrobial
时间窗: 1 year
property than Chlorhexidine gluconate as an
时间窗: 1 year
irrigant in primary teeth.
时间窗: 1 year
次要结局
- Chlorhexidine gluconate may have better antimicrobial(property than Silver diamine fluoride as an irrigant in)
