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临床试验/NCT04348578
NCT04348578已完成不适用

Effect of QMix 2-in-1 as Final Irrigation Protocol on Periapical Healing After Single-visit Root Canal Treatment: a Randomized Controlled Trial

Cukurova University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Radiographic healing after 12 months follow-up.

研究概览

简要总结

Aim: To compare the 12-month radiographic outcome of root canal treatment with and without the additional use of QMix 2-in-1 (Dentsply Tulsa, Maillefer, Ballaigues, Switzerland) irrigation solution.

Methodology: The study included 60 single-rooted teeth with periapical radiolucency of 60 patients, randomized into two groups using randomized block design with block sizes of 10 patients in each. Root canals were prepared with WaveOne Gold files (Dentsply Sirona, Maillefer, Ballaigues, Switzerland) and irrigation was performed with 5 mL 2.5% sodium hypochlorite (NaOCl) using side-vented needles during instrumentation. The final irrigation protocol was performed using 5 mL 2.5% NaOCl (n= 30) or 5 ml QMix 2-in-1 (n=30). Then the root canals were irrigated with 5 mL of distilled water and filled with gutta-percha and AH Plus sealer (Dentsply Sirona), using the cold lateral compaction technique. The patients were recalled after 12 months and evaluated radiographically according to perapical index (PAI) scores. Pre and post-treatment PAI scores were compared and teeth were considered 'healthy' (PAI ≤ 2) or 'diseased' (PAI ≥ 3). The Mann Whitney U test was used to compare the differences between the post-operative and follow-up images of the treatment groups. The Wilcoxon signed rank test was applied to examine the changes in PAI score from baseline to the follow-up evaluation in each group.

详细描述

This randomized controlled trial was conducted to evaluate radiographic periapical repair after endodontic treatment using QMix 2-in-1 (Dentsply Tulsa, Maillefer, Ballaigues, Switzerland) and NaOCl irrigation in single-rooted teeth with apical periodontitis.

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
Single (Participant)

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

  • necrotic, single root teeth with a periapical lesion (2>PAI>5)

排除标准

  • had used antibiotics within the previous week
  • allergy to local anesthetic agents
  • history of intolerance to non-steroidal anti-inflammatory drugs
  • had uncontrolled hypertension, uncontrolled diabetes mellitus, chronic renal failure, hematological disease, or had received or were receiving radiotherapy and periodontal bone loss (visualized radiographically)
  • open tooth apex

结局指标

主要结局

Radiographic healing after 12 months follow-up.

时间窗: Time frame is 12 months for this study. Each patient will recall for an appointment and the status of the tooth will evaluate radiographically.

After the completion of treatment of both control and QMix 2in1 group, the status of periapical healing was assessed.

次要结局

未报告次要终点

研究者

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

Cemre Sapmaz Uçan

Research Asistant

Cukurova University

研究点 (2)

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