Anesthetic Effectiveness of Lidocaine Versus Articaine in Dentistry. A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of tubes
研究概览
简要总结
Context: Lidocaine and articaine are two of the most commonly used local anesthetics in dentistry. Lidocaine has often been the anesthetic of choice in clinical practice, but in clinical experience, articaine has proven to be more effective in controlling pain during dental procedures. (Camps-Font, O. et al. 2020).
There are still unanswered questions, such as which of the two local anesthetics is more effective in reducing pain? This could lead us to discuss which one to choose to reduce costs in the dental office.
Objective: The objective of this project is to determine and compare the effectiveness of lidocaine and articaine in clinical contexts such as tooth extraction with infiltrative techniques, seeking to provide answers that will optimize the choice of anesthetic based on the patient and the procedure, thus improving pain management and reducing costs in the dental office.
Design: Randomized double-blind experimental study, parallel groups. The control group received 2% lidocaine, and the experimental group received 4% articaine. The study will be conducted in accordance with the guidelines of the Consolidated Standards of Reporting Trials (CONSORT 2010). The probabilistic sampling technique is through simple randomization. The 100 patients who meet the inclusion criteria will be randomly assigned to the control and experimental groups in a 1:1 ratio.
Expected results: articaine shows a lower percentage of extractions with anesthetic reinforcement and, therefore, a lower average number of additional tubes.
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
- Double (Participant, Care Provider)
盲法说明
Blinding will be performed by the study investigators. The RCT is a double-blind trial, where neither the operator nor the patient knows the result of the anesthesia being administered.
The preparation of the intervention will be carried out by dividing the anesthetic cartridges, 50 for the control group (lidocaine) and 50 for the experimental group (articaine).
Since both articaine and lidocaine are from the same manufacturer, they have the same color silicone plunger, so we will simply cover the logo with an adhesive sticker and store them in a box. To distinguish which of the tubes corresponds to articaine or lidocaine once they have the sticker, they will be assigned the same numbers that will be used to randomize each patient (1 and 2 interleaved), with No. 1 being articaine and No. 2 being lidocaine. These will be in their respective boxes with their numbering.
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
- 是
入选标准
- •Patients with clinical indications for simple extraction of upper and lower teeth using infiltrative anesthetic techniques.
- •Patients without systemic diseases (ASA I)
- •Patients with controlled systemic disease (ASA II)
- •Patients with no history of hypersensitivity to anesthetics or their components (epinephrine)
- •Patients with stable periodontal condition, without active infection that could affect the diffusion of the anesthetic.
- •Patients with the ability to understand the procedure and provide informed consent.
排除标准
- •Patients with uncontrolled systemic diseases ASA III and pregnant patients.
- •Patients requiring trunk techniques (Gow gates, Spix, Carrea)
- •Patients taking medication that affects the anesthetic response (tricyclic antidepressants, anticoagulants)
- •Patients with a history of neurological or psychiatric disorders that may influence the perception of pain or anxiety.
- •Patients with anatomical abnormalities in the orofacial region that interfere with the administration or action of anesthesia.
- •Patients with a history of recent substance abuse.
结局指标
主要结局
Number of tubes
时间窗: immediately after the procedure
continuous quantitative variable
次要结局
- Pain during dislocation using the Visual Analog Scale (VAS) for pain with a minimum of 0 meaning no pain, and a maximum of 10 meaning the most severe pain ever experienced in life.(After the procedure)