Comparison of the Efficacy and Safety of Two Homologous Active Principles for Local Dental Anesthesia: Non-inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Number of patients with total absence of sensitivity and pain
研究概览
简要总结
In the complexity of the Dental care the third molar surgery is one of the most common procedures, it is indicated for multiple reasons like infections in root canal, prosthetics or even esthetical purposes. This surgery can be safely performed with the help of local anesthetics, due to their quick action, and reversibility to control pain, reducing possible complications during and after the surgeries.
Among the different types of local anesthetics used in dentistry, the articaine bears characteristics that provide some advantages compared to similar anesthetics like Lidocaine, being one of the most used anesthetics worldwide. Different authors have concluded that it is a safe when used in patients at different ages and it is effective as a local anesthetic in the majority of procedures. It is important for dentists to know the differences or similarities of anesthetics in terms of their effects, safety, dosages required in patients undergoing surgical removal of teeth, as well as the mechanism of action and pharmacological properties, in order to take advantage of its benefits and minimize risks.
This study aims to test the efficacy and safety of an anesthetic solution, based on the same active molecule, articaine, manufactured by two different commercial houses, one domestic and one international, in order to gather scientific evidence and to show that they are not different. This will provide scientific results to help in the selection of any of these brands to be used with confidence in the dental practice. This will strengthen the collaboration between the academy and the companies, which would allow them to improve the quality of their products.
Locally there are no studies available comparing the articaine-type anesthetic with epinephrine at the same concentration, manufactured locally by a national company, to a foreign one, which is an important opportunity to expand the knowledge and create scientific reports, about what a local anesthetic is and what it does.
Finally, this study would contribute to the need to guarantee the quality of medicines in Colombia, by means of compliance with the legal provisions contemplated in resolution 1890 of November 2001 and 1400 of August 2001, issued by the Ministry of Health of Colombia : "Requirements to demonstrate the therapeutic effectiveness, through studies of Bioavailability and Bioequivalence of medicines for a special group of them.
详细描述
Local anesthetic:
Local anesthetics are widely used in dentistry for different procedures and are chemical substances that block nerve conduction, temporarily and irreversibly in order to avoid pain and are placed in specific sites of the body, for example in oral tissues.
Pharmacology of local anesthetics related to effectiveness and safety
Latency time It is defined as the time that elapses between the infiltration of the anesthetic substance in the tissue until the first signs of insensibility are felt. It is influenced by the distance of the route the anesthetic must travel, with the ability to cross the membrane of the nerve cells.
Duration of the anesthetic effect Also known as the duration of the action, related to the capacity of fixation of the anesthetic substance to the nerve cell proteins and with lipid solubility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Both anesthetics will be masked so that no differences are observed between them at the time of their application by the surgeon, clinical monitor and patient. Therefore, they will be covered with adhesive paper marked with the letter A or B. Each pair of anesthetics will be stored in an envelope and inside it will say the side that would apply each anesthetic (right or left) and each envelope will have a consecutive number from 1 to 196, and will be delivered to each patient in order of arrival at the study.
Being a double blind study, it must be guaranteed that neither the patient, nor the surgeon, nor the clinical monitor knows about the allocation of treatments at the time of intervention.
入排标准
- 年龄范围
- 18 Years 至 22 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women, criteria assessed during anamnesis
- •Age between 18 and 25 years old
- •Presence of lower third molars in the mouth with no level of eruption determined by the clinical oral examination
- •Weight / height ratio with a coefficient of variation of no more than 15% of the ideal weight, according to the tables of the Metropolitan Life Insurance
- •Lower third molars in a mesio-angulated position evidenced by the panoramic radiography taken for the study in the Faculty of Dentistry of the University of Antioquia, and which is in Nolla's stage equal or greater than 6
- •Voluntary acceptance to participate in the study by signing the informed consent
排除标准
- •Presence of phobias or traumas related to the dental practice and/or with needles
- •Presence of clinical problems such as kidney diseases, cardiovascular diseases, known allergies or drug hypersensitivity discovered through the anamnesis of the clinical history prepared for the investigation
- •Hi consumption of alcohol or cigarettes
- •Presence of problems related to drug dependence
- •Being ill for the last two weeks before the study begins
- •use of enzyme inhibitors or inducers for four weeks prior to the participation in the study
- •Have used any medication or natural product, seven days prior to the first part of the study
- •Have donated blood in the last three months
- •Have participated in another clinical trial, thirty days prior to the first part of the study
- •Be a member of the research group or a relative of the responsible personnel involved in the study.
研究组 & 干预措施
NS Lower right molar
IANB Artheek SP Articaine EPINEPHrine Cartridge 4% 1:100000
干预措施: Articaine / EPINEPHrine Cartridge (Drug)
SD Lower Left molar
IANB Septanest Articaine EPINEPHrine Cartridge 4% 1:100000
干预措施: Articaine / EPINEPHrine Cartridge (Drug)
NS Lower left molar
IANB Artheek SP Articaine EPINEPHrine Cartridge 4% 1:100000
干预措施: Articaine / EPINEPHrine Cartridge (Drug)
SD Lower right molar
IANB Septanest Articaine EPINEPHrine Cartridge 4% 1:100000
干预措施: Articaine / EPINEPHrine Cartridge (Drug)
结局指标
主要结局
Number of patients with total absence of sensitivity and pain
时间窗: 2 to 8 minutes
Assessment of total absence of tactile and pain sensitivity after administration of the anesthetics.
Failure
时间窗: 10 minutes
Assessment of the inability to block tactile sensitivity or painful sensitivity
Pain assessed by visual analogue pain scale
时间窗: One hour (1h)
Monitoring of the visual analogue pain (VAS) scale, where the amount of pain patient feels ranges from 0, non pain to 10, extreme amount of pain.
次要结局
未报告次要终点
研究者
Germán David Arboleda Toro
Assistant Professor
Universidad de Antioquia