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临床试验/NCT05406895
NCT05406895已完成不适用

Does the Use of CBCT Pre-operative Measurements Improve the Success Rate of Inferior Alveolar Nerve Block? - A Randomized Controlled Clinical Trial

Louisiana State University Health Sciences Center in New Orleans2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2022年5月25日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
2
试验地点
2
主要终点
Mental nerve numbness

研究概览

简要总结

The study looks to compare the success rate of lower jaw anesthesia injection (inferior alveolar nerve) that is guided by pre-treatment 3D dental scan (CBCT) versus standard injection technique.

详细描述

A total of 200 participants will be recruited that have existing 3D dental scans (CBCT) and require an implant placement (that will be placed in a two stage procedure) in the lower jaw for which a lower jaw anesthesia injection (inferior alveolar nerve) block will be used. The participants will be randomly assigned into one of two groups. The first group will receive the injection technique that is guided by pre-treatment measurements made from the 3D dental scan (CBCT) during implant placement surgery and if implant is placed as a two-stage procedure, during the second stage implant uncovery will receive the standard injection technique. The second group will receive the standard injection technique first at the implant placement surgery and if implant is placed as a two-stage procedure, during the second stage implant uncovery will receive the injection technique guided by the 3D dental scan (CBCT). If the implant is placed as a one-stage procedure, the second visit will not apply. Following this, subjective and objective measurements on the success of the anesthesia will be measured.

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)

盲法说明

The participants will be masked to which technique they are receiving.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients from the age 18 to 70 years old that are assigned to the 3 clinicians of the graduating class of LSUHSC School of Dentistry Post-graduate Periodontics program.
  • Patients have been reported as an ASA I or ASA II patient that has never had an allergic reaction to lidocaine based on previous dental experience.
  • The patient must be missing one or more mandibular teeth and is treatment planned for a mandibular implant that is placed that requires an inferior alveolar nerve block during surgery.
  • Patient must have an existing CBCT scan within the last year or is planned for a CBCT scan for the purpose of dental implant treatment.

排除标准

  • The exclusion criteria include patients that have undergone long term use or continuous use within the last week of opioids, analgesics, medications of nerve related pathology and non-steroidal anti-inflammatory drugs.
  • Patients diagnosed with trismus.
  • Patients that request for Nitrous and IV anesthesia
  • Patients missing remaining teeth in the quadrant or having a history of endodontic treatment of the remaining teeth in the quadrant.
  • Patients having endodontic or pulpal pathology in the teeth in the quadrant.

结局指标

主要结局

Mental nerve numbness

时间窗: 2 hours

Numbness of lips, numbness of buccal gingival tissue of canine

Inferior alveolar nerve numbness

时间窗: 2 hours

Numbness of buccal gingival tissue of molar

Lingual nerve numbness

时间窗: 2 hours

Numbness of tongue, numbness of lingual tissue

次要结局

  • Pain during surgery(At the end of the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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