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临床试验/CTRI/2025/09/094546
CTRI/2025/09/094546尚未招募4 期

A comparative evaluation of calcium hydroxide and triple antibiotic paste with and without silver nanoparticles on microbial load and post operative pain: An in vivo study.

Dr. Keshav Singla1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Microbial load reduction and impact on post operative pain.

研究概览

简要总结

Postoperative pain primarily results from microorganisms in the root canal system. Since mechanical instrumentation alone may not eliminate all bacteria, intracanal medicaments are recommended. Calcium hydroxide is the most commonly used medicament, while triple antibiotic paste (TAP) is another effective option. Recently, silver nanoparticles have gained attention for their antimicrobial properties. The purpose of this in vivo study is to evaluate and compare the reduction in microbial load and postoperative pain scores associated with the use of calcium hydroxide and triple antibiotic paste (TAP), both with and without silver nanoparticles. This study is a randomised, double blind, parallel group, study comparing and evaluating the microbial load reduction and effect on post-operative pain of calcium hydroxide and triple antibiotic paste with and without silver nanoparticles.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Subjects which have non-contributory medical history.
  • Teeth with pulpal necrosis and periapical pathosis will be selected, PAI score more than 2 less than
  • Teeth with enough crown structure for adequate isolation with rubber dam.
  • Teeth with favourable root morphology
  • Teeth that are restorable.
  • Teeth with completely formed apices and without internal resorption will be selected.

排除标准

  • Medically compromised patients or patients who are allergic to drugs.
  • PAI score equal to or more than
  • Pregnant females
  • Patients with Immunocompromising disorders.
  • Teeth with abscess, fistula or sinus tract, previously root canal treated teeth.
  • Grade I mobility or pocket depth more than 5 mm or radiographic evidence of external or internal root resorption.
  • Teeth that are unrestorable.
  • Antibiotics use within the past 30 days and patients who have some general disease.
  • Teeth with incompletely formed apices and internal resorption.

结局指标

主要结局

Microbial load reduction and impact on post operative pain.

时间窗: 1 year 6 months

次要结局

  • Antimicrobial efficacy of calcium hydroxide, as an intracanal medicament with and without silver nanoparticles.(1 year 6 months)
  • Antimicrobial efficacy of triple antibiotic paste, as an intracanal medicament with and without silver nanoparticles.(1 year 6 months)
  • Post-operative pain following the use of calcium hydroxide as an intracanal medicament, with and without the addition of silver nanoparticles.(1 year 6 months)
  • Post-operative pain following the use of triple antibiotic paste as an intracanal medicament, with and without the addition of silver nanoparticles.(1 year 6 months)

研究者

发起方
Dr. Keshav Singla
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Keshav Singla

Dasmesh Institute of Research and Dental Sciences, Faridkot

研究点 (1)

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