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临床试验/NCT05804630
NCT05804630Enrolling By Invitation不适用

Efficacy and Safety of Articaine and Lidocaine in Extraction of Wisdom Teeth of Upper and Lower Jaws

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
60
试验地点
1
主要终点
Hemodynamic measures

研究概览

简要总结

Local anesthesia drugs and anesthesia technique play an imperative role in dental treatment. The purpose of this study was to compare the efficacy and safety of different dental local anesthetics drugs and brands in clinical use for the extraction of wisdom teeth.

详细描述

Local anesthesia drugs and anesthesia technique play an imperative role in dental treatment. They are widely used in oral and maxillofacial surgery, endodontic treatment, periodontal treatment, prosthetics and operative dentistry. They not only reduce the pain of the patient during the treatment, but also improve the comfort of the treatment. The most commonly used local anesthetics are Lidocaine and Articaine, whose efficacy and safety have been demonstrated in many literatures: fast-acting, effective in pain control, comfortable, relatively rare allergic reaction, few local and systemic adverse effects.

Among the above-mentioned drugs, Articaine is an anesthetic drug that has been developed and become popular in recent years. In the past, literature pointed out that due to the relationship between the drug concentration and structure of Articaine, its ability to penetrate into bone is better than that of Lidocaine. Some studies even believe that local infiltration with Articaine can replace block anesthesia with Lidocaine; which means, on the one hand, it is more comfortable during anesthesia. On the other hand, it can avoid the potential adverse effects of block anesthesia, such as: hematoma formation and systemic adverse effects caused by intravascular injection.

For exodontia surgery, a quite common surgery for general dentists and oral surgeons, the most commonly used anesthesia techniques are local infiltration and block anesthesia. The purpose of this study was to compare the efficacy and safety of different dental local anesthetics drugs and brands in clinical use for the extraction of impacted wisdom teeth. Three types of local anesthetics that have been widely used and proven safe were included:

  1. Xylestesin-A® (1.7mL/cartridge contains 20mg/mL Lidocaine + 1:80,000 epinephrine)
  2. Octocaine® (1.8mL/cartridge contains 20mg/mL Lidocaine + 1:100,000 epinephrine)
  3. Orabloc® (1.8mL/cartridge contains 40mg/mL Articaine + 1:100,000 epinephrine)

This study will be a randomized split-mouth clinical study, and it will include 60 healthy adult patients aged between 20-60 years old, who are evaluated by a single surgeon to be suitable for extraction or odontectomy of their impacted third molars (upper or lower jaws) under local anesthesia. This study consists of two experiments. The above 60 patients will be randomly assigned to group 1 or 2, using different anesthetic drugs or anesthesia techniques:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged between 20-60 years old
  • Generally healthy or with well-controlled mild systemic diseases (such as well-controlled hypertension, diabetes, or hyperlipidemia)
  • Bilateral wisdom teeth with similar difficulty of surgery(according to Pell and Gregory and Winter's classification), which are indicated for surgical removal under local anesthesia

排除标准

  • Known or suspected allergy to amide-type local anesthetic agents
  • With systemic contraindication for tooth extraction, such as poorly-controlled heart diseases or diabetes, and severe liver or kidney diseases. Patients with systolic blood pressure greater than 150 mmHg or less than 90 mmHg or diastolic blood pressure greater than 100 mmHg or less than 60 mmHg are also excluded
  • With local contraindication for tooth extraction, such as previous irradiation to the surgical region, acute infection or cellulitis at the surgical region
  • Patients during pregnancy or lactation
  • Patients taking analgesic or sedatives in 24 hrs
  • Intolerant of dental extraction surgery under local anesthesia due to anxiety, dentophobia, or pain

研究组 & 干预措施

Experiment 1, arm 1: Articaine infiltration anesthesia

Active Comparator

This arm aims to compare efficacy and safety of infiltration anesthesia of Articaine (Orabloc®) to block anesthesia of Lidocaine (Octocaine®). It would be a split-mouth study design. The patient in this arm would be randomly assigned to one anesthetic agent and technique at one side (left or right) of the wisdom tooth surgery first, and the other side (left or right) of wisdom tooth surgery would use the other anesthetic agent and technique accordingly.

干预措施: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®) (Drug)

Experiment 1, arm 2: Lidocaine block anesthesia

Active Comparator

This arm aims to compare efficacy and safety of infiltration anesthesia of Articaine (Orabloc®) to block anesthesia of Lidocaine (Octocaine®). It would be a split-mouth study design. The patient in this arm would be randomly assigned to one anesthetic agent and technique at one side (left or right) of the wisdom tooth surgery first, and the other side (left or right) of wisdom tooth surgery would use the other anesthetic agent and technique accordingly.

干预措施: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®) (Drug)

Experiment 2, arm 1: Lidocaine+1:100000 adrenaline block anesthesia

Active Comparator

This arm aims to compare efficacy and safety of block anesthesia of Lidocaine containing different concentration of epinephrine (adrenaline), i.e. Octocaine® (Lidocaine+1:100000 adrenaline) vs. Xylestesin-A® (Lidocaine+1:80000 adrenaline). It would be a split-mouth study design. The patients in this arm would be randomly assigned to one anesthetic agent at one side (left or right) of the wisdom tooth surgery first, and the other side (left or right) of wisdom tooth surgery would use the other anesthetic agent accordingly.

干预措施: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®) (Drug)

Experiment 2, arm 2: Lidocaine+1:80000 adrenaline block anesthesia

Active Comparator

This arm aims to compare efficacy and safety of block anesthesia of Lidocaine containing different concentration of epinephrine (adrenaline), i.e. Octocaine® (Lidocaine+1:100000 adrenaline) vs. Xylestesin-A® (Lidocaine+1:80000 adrenaline). It would be a split-mouth study design. The patients in this arm would be randomly assigned to one anesthetic agent at one side (left or right) of the wisdom tooth surgery first, and the other side (left or right) of wisdom tooth surgery would use the other anesthetic agent accordingly.

干预措施: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®) (Drug)

结局指标

主要结局

Hemodynamic measures

时间窗: Recorded immediate before local anesthesia, immediate after local anesthesia, 5 minutes after local anesthesia and immediate after surgery

Blood pressure (Systolic pressure and diastolic pressure)

Pain and satisfaction of the surgery

时间窗: Recorded immediate after each dental extraction surgery

Pain according to VAS (0-10) and satisfaction score (1-5, "1" being the least satisfactory and "5" being the most satisfactory)

O2 saturation (SpO2)

时间窗: Recorded immediate before local anesthesia, immediate after local anesthesia, 5 minutes after local anesthesia and immediate after surgery

O2 saturation (SpO2)

次要结局

  • Adverse events of anesthesia(Recorded during and interview the patient immediate after each dental extraction surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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