Evaluation of Articaine 4% Versus Mepivacaine 2% for Surgery of Molars Thirds: Splint-mouth Randomized Double Blind Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Pain assessment
研究概览
简要总结
The extraction of third molars, a frequent treatment in clinical dental practice, can lead patients to painful symptoms during and after surgery. The dental surgeon must correctly indicate the need for extraction and also provide patients who need this treatment greater comfort and control of pain in the trans and postoperative period. Thus, it is necessary to use an effective local anesthetic favoring the factors inherent to the postoperative and achieving good treatment results.
详细描述
This study will compare the use of Articaine at 4% to that of Mepivacaine at 2% for lower third molar surgeries semi-included and / or included. I will select 16 patients who require surgical treatment for extraction of third molars, aged between 16 and 40 years at the São Paulo State University. These will participate simultaneously in the two groups: Group 1 mepivacaine (MEP) and Group 2 articaine (ART), and the division will be performed by randomization, so that each patient will have each side (right or left) allocated in different groups. The primary evaluation variable will be to compare the pain index in the immediate postoperative period, using Visual Analog Scale (VAS), and will also analyze Hemodynamic Parameters, such as Patient and Operator satisfaction. The results will be submitted to qualitative and quantitative statistical analysis. The descriptive data will be compared using the statistical analysis of variance (ANOVA) and Tukey test with a significance level of 5%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
Surgical procedures were always performed by the same surgeon and assistant, who was unaware of the group that belonged to the patient, as well as the patient himself. This randomization was performed involving numbers and envelopes, being only the investigator's knowledge.
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists Classification -(ASA I) patients;
- •Patients with need for extraction of lower third molars included and / or semi-included;
- •Teeth in opposing hemiarch with the same classifications as Pell and Gregory and Winter;
- •Age between 16 and 40 years;
- •Patients who agree to voluntarily participate in the survey.
排除标准
- •History of allergic reactions (hypersensitivity) to anesthetics;
- •Patients presenting with local or systemic alterations that contraindicate the procedure;
- •Current use of drugs that may interfere with the action of anesthetics;
- •Need for sedatives or anxiolytic drugs during extraction;
- •Pregnancy or breastfeeding;
- •Third erupted lower third molars.
研究组 & 干预措施
Group 1-Pain monitor
Use of the anesthetic Mepivacaine 2% in third molar extraction
干预措施: Group 2 -Pain monitor (Diagnostic Test)
Group 2 -Pain monitor
Use of the anesthetic Articaine 4% in third molar extraction
干预措施: Group 1 -Pain monitor (Diagnostic Test)
结局指标
主要结局
Pain assessment
时间窗: The scale will be provided on paper and divided into postoperative hours up to 3 days.
Evaluated in patients in groups 1 and 2. Scale of Visual Analog Scale (VAS), with values from zero to ten, being zero without pain and ten the maximum of pain. This scale will be provided on paper and divided into postoperative hours up to 3 days.
次要结局
- Assessment of blood pressure change(Observed and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesia)
研究者
Michelle Bianchi de Moraes
Assistant Professor, Department of Diagnosis and Surgery, São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, Brazil.
Universidade Estadual Paulista Júlio de Mesquita Filho