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临床试验/CTRI/2024/05/068201
CTRI/2024/05/068201尚未招募3 期

Analysis of microorganisms found in Root canal with Periapical lesions and evaluation of antimicrobial efficacy of combination of Calcium Hydroxide and Chitosan as Intracanal Medicaments.

Institute of Dental Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年6月19日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Healing of periapical lesions

研究概览

简要总结

Detailed case history including demographic details, medical history, oral health assessment status of the patients will be recorded. Radiographic examination will be done to evaluate the periapical status of the involved teeth. Based on the intracanal medicaments used, samples will be categorised in 3 groups:-

Group A - Calcium hydroxide alone

Group B - Calcium Hydroxide + Chlorhexidine

Group C - Calcium Hydroxide + Chitosan

Access opening will be done under rubber dam isolation after administration of local anesthesia. After locating the orifices, they are enlarged using orifice openers. First microbial samples will be collected using No 15/4% paper points keeping them within the canals for a minute. These paper points will be transferred to Institute’s Central Laboratory for microbiological assays and evaluation along with qualitative PCR. Intracanal medicaments will be placed inside the canals using lentulospirals and the patients are recalled after 14 days. In second appointment, after re-access opening, second microbial samples will be collected using No 15/4% paper points which will again be sent to the lab to identify the microorganisms along with its colony forming units to evaluate the decrease/increase in microbial load. Obturation will be done followed by composite access restoration. The obtained data will be subjected to statistical analysis. All the above procedures will be done after taking patients’ written consent.

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, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
17.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with periapical lesions Age (17-65 yrs) Single and multi-rooted teeth.

排除标准

  • Any signs of internal or external root resorption Mobility of teeth History of taking antibiotics within the preceding month.

结局指标

主要结局

Healing of periapical lesions

时间窗: 1 month, 3 months, 6 months ,12 months

次要结局

  • Post operative pain(1 week , 1 month, 12 months)

研究者

发起方
Institute of Dental Sciences
申办方类型
Research institution and hospital

研究点 (1)

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