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临床试验/NCT07106307
NCT07106307已完成不适用

Evaluation of the Effect of Different Root Canal Obturation Techniques on the Success of Root Canal Treatment in Teeth With Apical Periodontitis

Medipol University1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
168
试验地点
1
主要终点
Periapical Healing

研究概览

简要总结

The aim of this clinical study is to evaluate the effect of root canal filling, which is the last stage of root canal treatment (RCT), on the post-operative pain level on single rooted permanent teeth with wide lesions with apical periodontitis, and the effect on the healing of the periapical tissue and lesion by comparing periapical radyography images, which was taken at the beginning and after one year.

详细描述

This study aims to evaluate the impact of different root canal filling techniques on postoperative pain levels and the healing of periapical tissues in teeth with periapical lesions, using periapical radiographic imaging. Specifically, the effects of resin-based sealers, bioceramic-based sealers, and two obturation techniques-cold lateral compaction and warm vertical compaction-will be compared. Postoperative pain will be assessed using VAS (Visual Analog Scale) and VRS (Verbal Rating Scale) following the final stage of root canal treatment in incisor and premolar teeth with single roots. Additionally, the healing of periapical lesions will be evaluated by comparing periapical radiographs taken at baseline and at a one-year follow-up. To date, no study has been found in the literature that evaluates these specific combinations of materials and techniques using periapical radiographic imaging.

The study includes four experimental groups based on the combination of obturation technique and sealer type as follows:

Group 1: Cold lateral compaction with AH Plus (epoxy resin-based sealer)

Group 2: Cold lateral compaction with AH Plus Bioceramic (calcium silicate-based sealer)

Group 3: Warm vertical compaction with AH Plus

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Single rooted anterior and premolar teeth with radiographically confirmed periapical lesions classified as Periapical Index (PAI) scores of 4 or 5 will be included in the analysis
  • Age between 18 and 60 years
  • Systemically healthy individuals
  • To be able to read and sign the informed consent form
  • Physical and mental fitness to undergo treatment
  • Willingness to attend all follow-up sessions

排除标准

  • Patients with systemic diseases classified as ASA III or higher
  • Presence of severe periodontal disease (probing depth >4 mm)
  • Use of analgesics within the last 12 hours or antibiotics within the past month before the treatment

结局指标

主要结局

Periapical Healing

时间窗: From end of treatment to 1 year

The primary outcome of this study is periapical healing. It will be assessed radiographically using standardized periapical images (taken with the parallel technique), captured preoperatively and at the 1-year follow-up, and evaluated using the Periapical Index (PAI) score by two blinded observers. The PAI score ranges from 1 (healthy periapical structures) to 5 (severe periodontitis).

次要结局

  • Post Operative Pain İntensity(From end of treatment to 6, 12, 18, 24, 48, and 72 hours; 7 days; and 1 month after root canal treatment)
  • Post Operative Pain Intensity(From end of treatment to 6, 12, 18, 24, 48, and 72 hours; 7 days; and 1 month after root canal treatment)

研究者

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

ASLI USTA TAHMAZ

Principal Investigator, Department of Endodontics, Medipol University

Medipol University

研究点 (1)

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