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临床试验/NCT07671326
NCT07671326招募中不适用

Antibacterial Efficacy of Bioceramic and Calcium Hydroxide-Based Intracanal Medicaments in Endodontic Treatment

Medipol University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
24
试验地点
1
主要终点
Reduction in Intracanal Bacterial Load

研究概览

简要总结

This study evaluates the antibacterial effectiveness of two different intracanal medicaments, Bio-C Temp and UltraCal XS , in mandibular molar teeth with chronic apical periodontitis. Intracanal bacterial load is assessed before and after root canal preparation, after intracanal medicament removal, and after final irrigation using droplet digital PCR.

详细描述

This randomized controlled clinical trial investigates the effect of two different intracanal medicaments on the reduction of intracanal bacterial load in mandibular molar teeth diagnosed with chronic apical periodontitis. The study is conducted at Istanbul Medipol University Faculty of Dentistry, Department of Endodontics, and includes systemically healthy participants aged 18-65 years who require primary root canal treatment and present with radiographic evidence of periapical radiolucency.

Participants are randomly assigned to two groups. In the first group, Bio-C Temp is used as the intracanal medicament. In the second group, a UltraCal XS is applied. All teeth are isolated with a rubber dam, and the operative field is disinfected before access cavity preparation. After removal of previous restorations and caries, sterility control samples are collected from the tooth surface.

Working length is determined using an electronic apex locator and confirmed radiographically. Initial microbiological samples are collected from the root canals using sterile paper points. Root canal shaping is performed with heat-treated nickel-titanium rotary files, and canal enlargement is completed with a VDW Rotate #35/.04 file. The irrigation protocol includes 2.5% sodium hypochlorite and 17% EDTA, followed by passive ultrasonic irrigation using an IRRI S ultrasonic tip. Sodium hypochlorite is inactivated with 10% sodium thiosulfate before microbiological sampling.

After chemomechanical preparation, the assigned intracanal medicament is placed 1-2 mm short of the working length, and the access cavity is temporarily sealed. Participants are recalled after 14 days. At the second appointment, the intracanal medicament is removed mechanically and chemically. A neutralization step is performed before further sampling, and the final irrigation and ultrasonic activation protocol is repeated.

Bacterial samples are collected at different stages of treatment, including baseline, after chemomechanical preparation, after medicament removal, and after final irrigation. The bacterial load is quantified using droplet digital PCR, a sensitive molecular method that allows absolute quantification of bacterial DNA. This technique is used to compare the antibacterial effect of Bio-C Temp and calcium hydroxide and to evaluate bacterial reduction throughout the treatment protocol.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18 and 65 years
  • Being systemically healthy (ASA I or ASA II)
  • Mandibular molar teeth with a radiographically detectable radiolucent lesion in the periapical region
  • Willingness of the volunteer or their legal representative to participate in the study by signing the Informed Consent Form

排除标准

  • Patients who have received antibiotics or corticosteroids within the last 3 months
  • Patients with systemic diseases
  • Teeth that cannot be properly isolated with a rubber dam
  • Teeth with periodontal pockets >4 mm and teeth with crown/root fractures
  • Individuals who are undergoing or planning to start orthodontic treatment during the study period
  • Pregnant or breastfeeding individuals

研究组 & 干预措施

Bio-C Temp, a Calcium Silicate-Based Bioceramic Intracanal Medicament

Experimental

Intervention: Participants in this group receive Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament, after standardized chemomechanical root canal preparation and passive ultrasonic irrigation. The medicament is placed into the root canals 1-2 mm short of the working length, and the access cavity is temporarily sealed for 14 days.

干预措施: Root canal treatment with Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament (Procedure)

UltraCal XS, a Calcium Hydroxide-Based Intracanal Medicament

Active Comparator

Intervention: Participants in this group receive UltraCal XS, a calcium hydroxide-based intracanal medicament, after the same standardized chemomechanical root canal preparation and passive ultrasonic irrigation protocol. The medicament is placed into the root canals 1-2 mm short of the working length, and the access cavity is temporarily sealed for 14 days.

干预措施: Root canal treatment with UltraCal XS, a calcium hydroxide-based intracanal medicament (Procedure)

结局指标

主要结局

Reduction in Intracanal Bacterial Load

时间窗: From baseline microbiological sampling during the first appointment to post-medication and final irrigation sampling at the second appointment after 14 days.

Quantitative reduction in intracanal bacterial load in mandibular molar teeth with chronic apical periodontitis, as measured by Droplet Digital PCR (ddPCR), following standardized chemomechanical root canal preparation, passive ultrasonic irrigation, and the application of two different intracanal medicaments. Bacterial samples are collected at predetermined stages of treatment to compare the antibacterial effectiveness of Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament, and UltraCal XS, a calcium hydroxide-based intracanal medicament.

Reduction in Intracanal Bacterial Load

时间窗: From baseline microbiological sampling during the first appointment to post-medication and final irrigation sampling at the second appointment.

Quantitative reduction in intracanal bacterial load in mandibular molar teeth with chronic apical periodontitis, as measured by Droplet Digital PCR (ddPCR), following standardized chemomechanical root canal preparation, passive ultrasonic irrigation, and the application of two different intracanal medicaments. Bacterial samples are collected at predetermined stages of treatment to compare the antibacterial effectiveness of Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament, and UltraCal XS, a calcium hydroxide-based intracanal medicament.

次要结局

未报告次要终点

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Berke Turgut

Director, Clinical Research

Medipol University

研究点 (1)

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