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临床试验/NCT03802305
NCT03802305已完成不适用

Comparison of the Variations of the Cardiovascular Parameters and the Efficiency of the Osteocentral Anesthesia (Quicksleeper™) and the Locoregional Anesthesia in the Case of Mandibular Pulpitis

Nantes University Hospital2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年3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
72
试验地点
2
主要终点
time required (in minutes) to re-obtain the baseline cardiovascular parameters like reported before injection: expected event.

研究概览

简要总结

The irreversible acute pulpitis is the most common emergency at the hospital during dental consultation. Pulpitis are characterized by intense and spontaneous oro-facial pains. In case of mandibular molar, the emergency treatment consists in realizing a pulpotomy (eviction of cameral pulp) under locoregional anesthesia called inferior alveolar nerve block (IANB). The latter represents a real challenge, since inflammation may decrease its action. To mitigate this deficiency and the drawbacks of the IANB (onset and duration of the anesthesia, bites risk reported with IANB) other anesthesias are proposed. In particular the computerized intraosseous technique anesthesia of which the Quicksleeper™ system is a part. However, according to the observers, a mild to severe tachycardia have been reported.

Very few valid clinical trials exists on the subject, most being realized with systems of intraosseous anesthesia other than Quicksleeper™. Therefore, the aim of this study is first to analyze the variations of the cardiovascular parameters into two groups of anesthesia: locoregional anesthesia and Quicksleeper ™ system; and then, to compare the efficiency, side effects, operating consequences of both techniques. This study should provide better data about potential risk with computerized intraosseous technique such has Quicksleeper ™ system in healthy or cardiovascular risk patient.

详细描述

When the patient arrive in the dental care center, an initial assessment is made to get the diagnosis of irreversible pulpitis:

  1. Anamnesis:

acute and spontaneous oro-facial pain, pulsatile severe intensity, which could irradiate toward the ear and/or jaw, exacerbated by cold or hot. 2. Clinical exams: positive vitality tests (electric test and cold pressor test) 3. Further examination (radiography)

The inclusion and exclusion criteria will be checked and the informed consent of the patient will be taken. The patient is then randomized in one of the group (experimental or control). He will fill a questionnaire (Corah's scale) for evaluating his state of anxiety during care. A monitoring of cardiac parameters is made during the care at defined moment.

The patient evaluates his pain himself with the VAS (Visual Analog Score), before the intervention. The anesthesia is carried out by only one experimenter, with the Quickslepper™ handpiece but different specific needles.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • real irreversible pulpitis of a mandibular molar in dental emergency consultation at the Nantes hospital
  • Healthy patient without medical history (ASA 1), without treatment for heart rate distress (anti arrhythmic, beta-blocking drug)
  • Major and covered by the social security
  • Informed consent

排除标准

  • Pregnant and breastfeeding women
  • Adults under guardianships
  • Adults deprived of freedom
  • Impossibility to obtain for informed consent
  • Allergy to anesthetic components
  • Contraindication of vasoconstrictor
  • Angle closure glaucoma
  • Pheochromocytomas
  • Bisphosphonate IV
  • Irradiated patient (upper respiratory and gastrointestinal tract cancer)
  • Contraindication with Mono-amino oxidase inhibitors
  • Acute apical periodontitis
  • Pulpitis on wisdom teeth
  • Vital teeth with fixed prosthesis
  • Active periodontal disease
  • Local anatomic difficulty
  • No reference tooth for vitality dental test

结局指标

主要结局

time required (in minutes) to re-obtain the baseline cardiovascular parameters like reported before injection: expected event.

时间窗: at day 0, from T0 minute to T14 minutes

* 3 successive values of heart rate similar to those registered before injection. * 3 successive values of blood pressure (diastolic and systolic) similar to those registered before injection.

次要结局

  • Compare the pain of the patient between the two anesthetic techniques(3 days)
  • Compare the possible postoperative course between the 2 anesthetic techniques(3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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