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临床试验/NCT07197658
NCT07197658进行中(未招募)不适用

Prospective Healing Assessment After Application of Endodontic Microsurgery for Elimination of Apical Pathology By Use of Either a Rotary Bur for Osteotomy and Apical Root Resection, or Piezoelectric Unit for the Same Clinical Procedures

National and Kapodistrian University of Athens4 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2023年4月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
124
试验地点
4
主要终点
Two dimensional radiographic bone healing

研究概览

简要总结

The goal of this clinical trial is to compare bone healing after using apical tooth microsurgery to remove root end infection, either by use of rotary burs for cutting bone and root end, or by use of piezoelectric surgery for the same procedures.

The main questions it aims to answer are:

  • Is there a difference in bone healing and reformation between the two surgical procedures ?
  • Is there a difference in bone healing between cutting the bone with a rotary bur and cutting the bone with the 'bone window' technique that uses piezoelectric unit ?

详细描述

The aim of this study is to prospectively compare postsurgical healing after the use of microsurgical technique to eliminate apical pathology, either by use of rotary burs for osteotomy and root resection, or by use of piezoelectric surgery for the same clinical procedures. Null hypothesis is that there is no difference in healing and buccal bone thickness reformation between the two surgical procedures Another purpose of the study is to prospectively evaluate healing after the application of a novel buccal bone preservation technique, called the 'bone window' technique. The technique will be applied in a subgroup of patients on maxillary and mandibular premolar and molar teeth with an intact buccal cortical bone and healing and buccal bone reformation will be assessed at follow up. Null hypothesis in this part, is that there is no difference in healing and buccal bone preservation between osteotomy with a bur and the 'bone window' technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Age 18 years and older consenting to the surgical procedure as well as agreeing to preoperative, postoperative and at least one follow-up CBCT evaluation after 12 months
  • Noncontributory medical history (American Society of Anesthesiologists class I and II)
  • A history of previous endodontic treatment with radiographic presence of apical periodontitis
  • A true endodontic lesion: microsurgical classification A, B, or C according to Kim and Kratchman,
  • Lesion size 10 mm or smaller in diameter measured on preoperative CBCT
  • Coronal restoration should be present at the time of follow up examination.

排除标准

  • Nonconsenting patients and patients younger than 18 years of age
  • Medical history with American Society of Anesthesiologists class III to V
  • Insufficient coronal restoration
  • Nonrestorability or traumatized teeth
  • Teeth with microsurgical classification D, E, or F according to Kim and Kratchman,
  • Mobility I or higher
  • Radiographic presence of nonapical root resorption
  • Teeth with a vertical root fracture or coronal/ midroot perforation
  • Lesion size larger than 10 mm in diameter measured on preoperative CBCT
  • Use of bone graft material for regeneration

研究组 & 干预措施

Bone Window subgroup

Active Comparator

'Bone window' technique will be performed

干预措施: Endodontic microsurgery / bone window (Procedure)

Group 1 (Experimental Group) - Rotary bur

Experimental

Endodontic microsurgery will be performed by use of a rotary bur

干预措施: endodontic microsurgery / rotary bur osteotomy (Procedure)

Group 2 (Control Group) - Piezoelectric unit

Active Comparator

Endodontic microsurgery will be performed by use of a piezoelectric unit

干预措施: Endodontic microsurgery / piezo osteotomy (Procedure)

结局指标

主要结局

Two dimensional radiographic bone healing

时间窗: From execution of the microsurgical procedure to one year or later follow up examination

Bone healing will be measured on periapical radiograph using well established two dimensional criteria for bone healing assessment. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing

Three dimensional radiographic bone healing

时间窗: From execution of the microsurgical procedure to one year or later follow up examination

Bone healing will be measured on Cone Beam Computed Tomography (CBCT) scan using well established three dimensional criteria for bone healing assessment. Penn 3D criteria categorize healing using CBCT scans into three categories: complete healing, limited and unsatisfactory healing

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

Spyros Floratos

Principal Investigator

National and Kapodistrian University of Athens

研究点 (4)

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