Is the Direct Inferior Alveolar Nerve Block Required for Third Lower Molar Extraction?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Need for supplemental anesthesia [Efficacy]
研究概览
简要总结
This study is a Randomized Controlled Trial (RCT) which objective is to compare the effectiveness, efficacy and complication associated to an infiltrative anesthetic technique for the removal of lower third molars comparing it to the standard inferior alveolar nerve block using 4% articaine 1:100.000 epinephrine.
详细描述
The objective is to compare the anesthetic efficacy of an infiltrative anesthetic technique placed buccally between the first and second mandibular molars plus infiltration of the third molar's lingual mucosa with the direct inferior alveolar nerve block plus buccal nerve block for the extraction of lower wisdom teeth. All using 4% articaine 1:100.000 epinephrine. The first technique is to be referred as Alternative Technique (A.T.) and the second Standard Technique (S.T.) The study is being conducted at the Hospital Odontològic Universitat de Barcelona (Campus de Bellvitge) and is being carried out by members of the Oral Surgery and Implantology Master's program of the University of Barcelona.
The sample (110 patients) consists of patients in need of lower third molar extraction. All of them are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions. All patients derive from the Institut Català de la Salut-Consorci Sanitari.
The materials used are 1.8cc carpules of 4% articaine and 1:100.000 epinephrine, dental anesthetic syringe, dental anesthetic needles of 35 mm 27G and 25 mm 27G as well as all the documents necessary for data collection.
The determinations to be done are the pulpal anesthetic efficacy (in seconds, using a pulpometer), chin and tongue numbness (patient reported, measured in seconds), need for supplemental anesthesia, comfort (pain experienced during the punctions and during and after surgery), morbility (cramp sensation in the tongue or lip when performing the anesthetic technique, local and/or systemic complications).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
- The participant is not told which technique will be used on him/her.
- Surgeon does not know the anesthetic technique used to numb the third molar.
- When the statistician and primary investigator receive the collected data to be analyzed, the techniques are labeled 1 and 2.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lower third molars in any position (in accordance to Pell and Gregory and Winter classification) in need of extraction.
- •Healthy patients and patients with mild systemic disease without substantive functional limitations (ASA I-II).
- •Absence of acute infection in the third molar area.
- •Adequate intellectual capacity for understanding the nature and purpose of the study and fill the informed consent and questionaries appropriately.
排除标准
- •History of recent trauma in the maxillofacial area.
- •Articaine or lidocaine allergy.
- •Presence of a systemic pathology that contraindicates the use of local anesthetics with vasopressors.
- •Acute infection in the third molar area (in the las 30 days).
- •Surgeries taking more than 60 minutes (automatic dropout).
- •Unwillingness to participate or continue participating in the study.
- •A score equal or superior to 13 points in the Corah´s anxiety test.
- •Third molars in ectopic position.
- •Caries on the third molar.
研究组 & 干预措施
Infiltrative technique
Patients in this arm will have buccal and lingual infiltrative anesthesia with 4% articaine 1:100.000 epinephrine for third molar extraction.
干预措施: Infiltrative technique (Procedure)
Infiltrative technique
Patients in this arm will have buccal and lingual infiltrative anesthesia with 4% articaine 1:100.000 epinephrine for third molar extraction.
干预措施: Third molar extraction (Procedure)
Nerve block technique
Patients in this arm will have inferior alveolar nerve and buccal nerve block with 4% articaine 1:100.000 epinephrine for third molar extraction.
干预措施: Nerve block technique (Procedure)
Nerve block technique
Patients in this arm will have inferior alveolar nerve and buccal nerve block with 4% articaine 1:100.000 epinephrine for third molar extraction.
干预措施: Third molar extraction (Procedure)
结局指标
主要结局
Need for supplemental anesthesia [Efficacy]
时间窗: At the end of surgery (≤60 minutes after pulpal anesthesia is achieved)
Using a questionnaire filled by the surgeon at the end of surgery. Need for supplemental anesthesia (yes/no)
次要结局
- Morbidity(After local anesthetic injection (minute 0))
- Post operative pain(Day 7)
- Surgery pain(At the end of surgery (≤60 minutes after pulpal anesthesia is achieved))
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Day 7)
- Local anesthetic injection pain(After local anesthetic injection (minute 0))
- Latency(After anesthetic injection (approximately 0 to 360 seconds))
- Pulpal anesthesia(Minute 6 (after Vincent's sign is achieved))
研究者
Rui Figueiredo
Professor
University of Barcelona