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临床试验/CTRI/2026/02/102924
CTRI/2026/02/102924尚未招募不适用

Comparative evaluation of antibiotic paste (cotrimoxazole) V/S antibiotic paste (ciprofloxacin and metronidazole) in reduction of CFU and alleviation of post-operative pain in children aged 4-8 years. A Randomized Clinical Trial

Dr Nirbhay Vashistha1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Microbial contamination, Colony Forming Unit (CFU/ml) count.

研究概览

简要总结

AIM: To compare the effectiveness of antibiotic paste of  (Cotrimoxazole) with antibiotic paste of (Ciprofloxacin and Metronidazole) in reducing bacterial colony-forming units (CFU) and alleviating post-operative pain in children aged 4-8 years undergoing endodontic treatment.

40 healthy children aged between 4-10 years, who reported in the Department of Pediatric and Preventive Dentistry of RUHS College Of Dental Sciences, Jaipur that met the defined inclusion criteria will be recruited to participate in this clinical study and randomized into two groups:

Group 1 – Antibiotic paste (Cotrimoxazole)

Group 2 – Antibiotic paste (Ciprofloxacin and Metronidazole)

Succeeding access opening and Bio mechanical preparation, baseline bacterial sample will be taken using a sterile swab stick. After sample collection intracanal medicaments (both AB paste) will be placed in the root canals in respective groups. Using a visual analogue scale, pain scores will be measured at preoperative Sample will be sent to lab for bacterial Colony Forming Unit (CFU/ml) count. Post 72 hrs After removing temporary restoration bacterial sample will be taken like baseline sample collection. Visual analogue scale will be used the measure pain. Sample will be sent to lab for bacterial evaluation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Children aged 4-8 years old.
  • Frankel rating 3 or
  • Primary molars with chronic symptomatic irreversible pulpitis.
  • Root resorption 1/3rd.

排除标准

  • Frankel rating 1 or
  • Primary molars with abscess or sinus.
  • Patients on antibiotics or analgesics.
  • Root resorption more than 1/3rd.
  • Medically compromised or children with any systemic disorders.

结局指标

主要结局

Microbial contamination, Colony Forming Unit (CFU/ml) count.

时间窗: At Baseline and 72hr after intervention

次要结局

  • pain using visual analogue scale(preoperative and 72hr after intervention)

研究者

发起方
Dr Nirbhay Vashistha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nirbhay Vashistha

RUHS college of dental sciences, Shastri nagar, Jaipur, Rajasthan, 302016

研究点 (1)

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