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临床试验/NCT04336709
NCT04336709已完成2 期

Comparison of Anti-microbial Efficacy of Calcipex and Metapex in Endodontic Treatment of Chronic Apical Periodontitis

Aga Khan University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年4月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Antimicrobial efficacy

研究概览

简要总结

Introduction:

Pulpal necrosis may lead to spread of the infection from the pulp to involve the apex of the tooth and surrounding bone which when asymptomatic with periapical radiolucency on radiograph, is called chronic apical periodontitis. In order to eliminate the virulent bacteria and to overcome the inflammation in the root apex, endodontic treatment is the treatment of choice. Bacteria usually survive in the complex anatomy of the root canal system. In order to eliminate the remaining bacteria, various intracanal medicaments have been used widely however, there is controversy over their use and efficacy. Calcium hydroxide (CH) is the most commonly used intracanal medicament between root canal treatment sessions and available in different combinations. Multiple studies have been conducted to evaluate the effect of various types of CH based medicaments but whether CH with iodoform is more effective than CH alone against endodontic pathogens is a matter of controversy. In order to evaluate the true reduction in microbial load from the infected canals, microbial culture is a predictable and convenient tool.

Thus, this study aims to evaluate the antimicrobial effectiveness of inter-appointment intracanal medicament with either CH alone (Calcipex) or CH with iodoform (Metapex) for the treatment of infected root canals of teeth diagnosed with chronic apical periodontitis using colony forming unit (CFU).

Objective: To compare the anti-microbial efficacy of calcipex and metapex in endodontic treatment of teeth diagnosed with chronic apical periodontitis and to compare two different methods for removal of oil based intracanal medicaments.

Method: Approval from ERC is obtained. The selected subjects will be divided in to two study groups using a computer generated randomization list i.e., Group A - Calcipex group (n = 30) and Group B - Metapex group (n = 30). Two samples will be collected from the root canals for evaluation of microbial load after chemomechanical preparation (S1) (before use of intracanal medicament) and after usage of intra canal medicament (S2)(after 7 days).

Two techniques will be used for removal of oil based medicaments. Two radiographs will be obtained for each technique, after oil based medicament placement and after medicament removal for evaluation.

Data Analysis: Mean and standard deviation of continuous variable will be computed. Frequency distribution and proportion of categorical variables will be determined. Paired t-test will be used to assess difference bet¬ween antimicrobial efficacies within groups of medicaments. Independent sample t-test will be used to assess antimicrobial efficacies between groups. Level of significance will be kept at 0.05.

Mann whitney U test will be used to evaluate medicament removal between 2 groups and at three canal levels; coronal, middle and apical.

详细描述

This study aims to evaluate the antimicrobial effectiveness of inter-appointment intracanal medicament with either CH alone (Calcipex) or CH with iodoform (Metapex) for the treatment of infected root canals of teeth diagnosed with chronic apical periodontitis.

And, to compare the effectiveness of rotary master apical file with ultrasonic activation of endodontic file in the removal of oil based intracanal medicament from the canal.

Risk / Benefit Assessment At this point investigators are not anticipating any risk related to the trial intervention.

TRIAL DESIGN: Two-arm parallel design, Randomized controlled trial. SETTING: Dental Clinics, Aga Khan University Hospital, Karachi

EXPECTED DURATION OF TRIAL:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

the participant or the care provider cannot be masked due to difference in colors of the medicaments, Metapex being yellow. The investigator (lab technician) and outcome assessor will be masked regarding the groups.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Single rooted human permanent teeth
  • Single root canal clinically diagnosed with chronic apical periodontitis
  • No history of antibiotics use in last 3 months.

排除标准

  • Periodontally compromised teeth with Grade III mobility.
  • Endodontically non-salvageable teeth.
  • Immuno-compromised patients/systemic illness.
  • Excessive root resorption.
  • History of allergy to calcium hydroxide or iodoform.
  • Endodontic retreatment cases.

研究组 & 干预措施

Calcipex II

Active Comparator

Calcipex group Manufactures Nishika, Yamaguchi, Japan Color- White Formulation- Water based Duration- 7 days Form: Paste Frequency: Used once on 1st day only till canal fills. Composition- Water-based calcium hydroxide paste without radio contrast agent (Barium Sulfate) Packaging- (1 syringe of Calcipex Plain II (1.8g), 2 needles of Nishika Spin with 2 needle caps) Storage requirement- Room temperature (1-30℃).

干预措施: Calcipex II (Drug)

Metapex

Active Comparator

Metapex group Manufactures- Meta Biomed, Korea Color- Yellow Formulation- Oil based Duration- 7 days Form: Paste Frequency: Used once on 1st day only till canal fills. Composition- Premixed oil-based paste composed of Calcium Hydroxide with Iodoform and silicon oil Packaging-2.2g paste in 1 syringe. 20 disposable tips. 1 ring rotator for direction control of the tip Storage requirement- Room temperature (1-30℃).

干预措施: Metapex (Drug)

结局指标

主要结局

Antimicrobial efficacy

时间窗: 7 days

antimicrobial efficacy of intracanal medicament as measuring using Colony forming unit/ml via bacterial culture. The higher CFU/ml suggests more bacterial colonies. We expect the counts to reduce after using the intracanal medicament

次要结局

  • Efficacy of intracanal medicament removal(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Momina Anis Motiwala

Principal Investigator

Aga Khan University

研究点 (1)

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