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临床试验/CTRI/2023/03/050533
CTRI/2023/03/050533尚未招募不适用

CLINICAL INVESTIGATION OF ANTIMICROBIAL EFFICACY AND RESOLVIN E1 IMMUNOEXPRESSION USING CHITOSAN, N- ACETYL CYSTEINE AND CALCIUM HYDROXIDE INTRACANAL MEDICAMENTS IN APICAL PERIODONTITIS

Subiksha Kannan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月4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
60
试验地点
1
主要终点
Reduction of microbial load

研究概览

简要总结

INTRODUCTION: 

One of the primary goals of root canal treatment is to eliminate or reduce the levels of microorganisms present in root canals below a threshold compatible with the healing of periapical tissues.‘Programmed resolution’ at the tissue level involves the participation of resolvins, a type of immuno resolvents, which actively drive the resolution of inflammation.

Embracing the concept of ‘natural resolution of inflammation’ and the aim of healing through tissue regeneration, an ideal intracanal medication should possess numerous desirable properties, such as antimicrobial activity, biocompatibility, and also must be capable of promoting endogenous production of lipid mediators that actively drive the resolution of inflammation.

AIM:

The aim of the present study is to clinically investigate the antimicrobial efficacy of chitosan, N- acetyl cysteine and calcium hydroxide as intracanal medicaments and their influence on level of inflammatory mediator Resolvin E1 in apical periodontitis.

JUSTIFICATION: Only one RCT evaluating the influence of intracanal medicaments on the levels of resolvins in apical periodontitis and one RCT evaluating antimicrobial efficacy of chitosan.

METHODOLOGY:

Root canal procedure will be performed by single Post-Graduate student under strict aseptic condition with local anesthesia (2% lidocaine & epinephrine at 1:200000) and rubber dam isolation. After complete instrumentation and irrigation, the teeth will be randomly divided into three groups according to the intracanal medicaments to be used.

GROUPS:

Group I : Chitosan (n=20)

Group II: N - Acetyl cysteine (n=20)

Group III: Calcium hydroxide (n=20)

Samples for microbiological analysis and resolvin level evaluation will be done before and after intracanal medicament placement.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
15.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Single-rooted 2.Pulp necrosis and apical periodontitis
  • Presence of one root canal.

排除标准

  • 1.Patients who used antibiotics or antifungal medications in the past three months.
  • 2.Root canal treated teeth 3.Any systemic disease 4.Periodontal pockets deeper than 4 mm 5.Teeth that could not be adequately isolated with a rubber dam 6.Acute apical abscess.

结局指标

主要结局

Reduction of microbial load

时间窗: 3 months

次要结局

  • Level of RvE1 in periapical tissues(3 months)

研究者

发起方
Subiksha Kannan
申办方类型
Other [Principal Investigator]

研究点 (1)

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