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临床试验/CTRI/2024/05/068117
CTRI/2024/05/068117招募中4 期

Comparative Evaluation of three differ-ent intracanal medicaments for antimi-crobial efficacy in single rooted teeth with Pulp Necrosis and Asymptomatic Apical periodontitis–A Randomized double-blinded Clinical Study

Dr Bhandary Vidula Vijay1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年6月10日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
75
试验地点
1
主要终点
Comparative evaluation of reduction of colony forming units in the intervention, comparator and control groups.

研究概览

简要总结

Dental caries, a progressive disease of the dental hard tissue, if left untreated in its initial stages, may lead to pulpal, periapical, and/or intraradicular infections. Reduction or elimination of the bacterial infection seems to be one of the important factors for the success of endodontic treatment of teeth with necrotic pulp . However, several studies have reported that chemomechanical instrumentation alone is unable to eliminate all root canal bacteria. The remaining viable bacteria left in the root canal may multiply between appointments or following obturation often reaching a pathogenic level and leading to failure. Hence, a suitable intracanal medicament is required to disinfect the root canal system prior to obturation so as to promote healing and prevent recurrence. Calcium hydroxide is the most commonly used intracanal medicament during root canal therapy. Studies using agar diffusion method have reported that Calcium Hydroxide associated with an inert substance (distilled water, saline solution or glycerine) was ineffective in inhibiting the growth of several obligate and facultative anerobic bacteria8. To overcome this drawback a combination of different antibiotics has been studied to increase the scope of antibacterial coverage. DAP is an intracanal medicament that is a combination of metronidazole and ciprofloxacin. But calcium hydroxide and double antibiotic paste (DAP) can have deleterious effects on root dentin. Angelus Bio-C Temp is a ready-to-use bioceramic tricalcium silicate paste for intracanal dressing. Bio-C Temp (Angelus, Paraná, Brazil) is the first calcium-silicate based medicament for use between sessions. Bio-C Temp contains calcium silicates associated with calcium tungstate and titanium oxide radiopacifiers, besides calcium aluminate, calcium oxide and base resin. Bio-C Temp is a highly alkaline material that has microsized particles (<2 μm), which improve flow, penetration into dentinal tubules, and material reactivity, favoring the release of Ca2+ and OH– ions, and bactericidal action due to high pH (12.5). Despite thorough search in various databases like PubMed, Medline and EBSCO host conducted till March 2024 suggested no availability of studies evaluating the effect of Angelus Bio-C Temp on antimicrobial efficacy in vivo; this clinical study is therefore designed to compare and evaluate the antimicrobial efficacy of the same with that of Calcium Hydroxide and Double antibiotic paste in patients with pulp necrosis and asymptomatic apical periodontitis.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy patients (Category: American Society of Anaesthesiologists class 1) (ASA House of Delegates 2014)31 between age group of 18-60 years with maxillary or mandibular single rooted necrotic teeth with radiographic and clinical evidence of asymptomatic apical periodontitis will be included in the study.
  • Teeth with necrotic pulps confirmed clinically by pulp sensitivity tests will be included.
  • Patients having no previous history of endodontic treatment will be included.
  • Patients having periapical lesions with a periapical index score of 2 and above (Ørstavik et al.
  • will be included
  • A written informed consent will be taken from all the patients and only those patients ready to sign the consent form will be included in the study.

排除标准

  • Medically compromised patients will be excluded.
  • Patients who have received NSAIDs or antibiotic treatment in the three months before the study will be excluded.
  • Teeth with completely obliterated canals will be excluded.
  • Teeth with evidence of sinus tracts, pus discharge and weeping canals will be excluded.
  • Cases showing periodontal pocket depth deeper than 4mm will be excluded.
  • Teeth with open apex, root resorption or complex root canal anatomy will be excluded.
  • Teeth with developmental anomalies will be excluded.
  • Teeth with vertical root fractures, cracks will be excluded.
  • Pregnant and lactating women will be excluded.

结局指标

主要结局

Comparative evaluation of reduction of colony forming units in the intervention, comparator and control groups.

时间窗: Baseline(day of initiation of treatment) | 7th day

次要结局

未报告次要终点

研究者

发起方
Dr Bhandary Vidula Vijay
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr. Bhandary Vidula Vijay

K M Shah Dental College And Hospital

研究点 (1)

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