跳至主要内容
临床试验/NCT06031792
NCT06031792招募中不适用

A 2D and 3D Radiographic Assessment of the Healing Pattern Associated With Conventional and Piezoelectric Periradicular Endodontic Microsurgery

King Abdullah University Hospital2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
44
试验地点
2
主要终点
Radiographic Healing

研究概览

简要总结

Endodontic periradicular microsurgery is a dental procedure to treat apical periodontitis in cases in which healing has not occurred after non-surgical treatment or if it is not feasible. Recent advances in techniques and materials have resulted in more predictable outcomes. Piezotome is a new and innovative device, but limited evidence is available regarding its use in endodontics. The aim of this study is to assess the healing pattern of conventional periradicular microsurgery and piezoelectric periradicular microsurgery in 2- Dimensional and 3-Dimensional imaging, and further to perform histological analysis for the presence, location, and arrangement of bacteria in the excised apical portion of the root canal system.

详细描述

After meeting the inclusion criteria, a total of 44 Patients in need of endodontic microsurgery with persistent symptoms after acceptable primary root canal treatment or failed retreatment with persistent symptoms/periapical lesions will be included in this study. Participants will be randomly allocated to group one; conventional periradicular surgery or group two; piezoelectric periradicular microsurgery. A preoperative digital periapical and limited view cone beam computed tomography (CBCT) radiographs will be taken for each patient. At 12-18 months recall visit a second digital periapical radiograph and limited view CBCT will be taken. All images will be evaluated on high-definition LCD display with installed ImageJ software and CBCT software, and window settings will be fixed for all cases. Radiographs will be evaluated by two calibrated dentists. The excised root tip with their surrounding tissues will be fixed immediately after harvesting for 24 hours at 4 °C by immersion in 1% glutaraldehyde and 1% formaldehyde and referred to histopathologic laboratory. Fixed specimens will be demineralized in 10% formic acid and processed. Serial sectioning with hematoxylin and eosin staining will be done to locate the areas with the most severe reactions. In addition, the Taylor modification of the Brown-Brenn staining will be used to detect the presence of bacteria.

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

  • Medically fit patients
  • Age (18-65 )
  • Teeth that are periodontally healthy
  • Coronally sealed root canal treated teeth

排除标准

  • Patients with an active systematic disease that may affect the short- and long-term outcomes or restrict surgical intervention
  • Emotionally distressed patients
  • Patients who had received analgesics or antibiotics prior to surgery will be postponed
  • Cases where orthograde endodontic treatment is feasible, will be retreated at the post-graduate clinics and not included in this study
  • Teeth with poor prognosis (e.g., non-restorable, vertical root fracture, short roots, non-strategic tooth, endo-perio lesion

结局指标

主要结局

Radiographic Healing

时间窗: to measure periapical lesion through study completion, an average of 1 year

To compare conventional and piezotome endodontic apical surgery in terms of healing using 2-Dimensional and 3-Dimensional imaging CBCT.

Histological outcome

时间窗: one sample is taken and compared immediately after surgery

To correlate histological findings with clinical observation and radiographic findings for failed root canal treated teeth presenting

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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