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临床试验/CTRI/2021/09/036881
CTRI/2021/09/036881尚未招募1 期

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.

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年2月10日最近更新:

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)

研究者

发起方
未提供

研究点 (1)

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