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临床试验/CTRI/2024/05/067273
CTRI/2024/05/067273尚未招募4 期

Evaluation of anti microbial efficacy of two herbal products used as irrigants in primary endodontic infections in single rooted teeth - A Randomised Controlled Trial

R BOOBALAN1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年6月19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
72
试验地点
1
主要终点
Count of colony forming units before treatment.

研究概览

简要总结

purpose of this study is to comparatively evaluate antimicrobial efficacy of two herbal products neem and moringa extract used as irrigants with chlorhexidine in primary endodontic infections in single rooted teeth.

Each tooth will be anesthetized and isolated with a rubber dam followed by caries removal. The access cavity will be prepared using a high-speed endo access bur. The working length (WL) will be determined radiographically using RVG by placing a size #10 K-file. The patients will be randomly divided into three groups: Group I: 2% chlorhexidine gluconate (CHX), Group II: Neem juice extract (Azadirachta indica), Group III: moringa juice extract (Moringa olifera).Pretreatment sample (S1) will be obtained by using a sterile paper point immersed in transport media first followed by placing it into the canal for 60secs and then transferred to the test tubes containing transport media (Peptone water). Two samples will be taken for each tooth. Biomechanical preparation (BMP) will be done using step-back technique up to master apical size #40 K-file. Irrigation will be done with 6 mL of the irrigants. Post-instrumentation sample (S2) will be similarly collected after irrigation as S1. It will be sent to the laboratory for processing within 2 hours. After this, teeth will be obturated using gutta-percha as a master cone and ZOE sealer. Microbiological samples (S1, S2,) will be sent to the lab Tropical Institute of Ecological Sciences(TIES)at Kottayam. Samples will be preincubated for 30 minutes and shaken vigorously in a vortex mixer for 60 seconds and will be plated on brain heart infusion agar and colonies will be counted after 24 hours using classic bacterial counting method. Both the session of treatment will be performed by the same examiner for each patient. The examiner will be aware of the material being used in every patient.

A fidelity checklist will be developed using pertinent literature and after due consideration. An observer will fill the fidelity check list to ensure objectivity and transparency.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
15.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Teeth with necrotic or infected pulp diagnosed clinically and radiographically Teeth with an adequate coronal structure.

排除标准

  • Patients with systemic conditions, acute periapical abscess, retreatment cases, root fractures Teeth with calcified canals, sinus opening in mature apexes Internal or external resorption.

结局指标

主要结局

Count of colony forming units before treatment.

时间窗: Within 1hr of sample collected

次要结局

  • Count of colony forming units after treatment(Within 1hr of sample collected)

研究者

发起方
R BOOBALAN
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

R BOOBALAN

Government Dental College Kottayam

研究点 (1)

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