Prospective Randomized Multicenter Study Between Two Anesthetic Techniques for Implant Placement in the Posterior Mandible
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 16
- 主要终点
- Satisfaction of the Patient by Numerical Rating Scale
研究概览
简要总结
To evaluate in a comparative way the patient's perception in implant surgery in the posterior mandibular quadrants depending on whether the operation is performed under trunk anaesthesia or infiltrative anaesthesia, in both cases with Articaine.
Randomized and multicenter prospective study to be developed in eight centers with similar socio-professional characteristics, with the same operative protocol.
A significant sample of patients will be randomized to undergo the same intervention (surgery to place implants in the posterior mandible) under one or another type of anesthesia (inferior alveolar block nerve or infiltrative) and data will be collected using a Numerical Rate scale on four occasions (after the incision, after drilling, after suturing and after 12h).
详细描述
The optimal anesthesia for posterior mandibular implant surgery remains controversial and dependent on operator's preferences. Although not evidence-based, most operators usually avoid infiltration anesthesia in the posterior mandible due to its uncertain efficacy. However, various comparative studies with articaine 4% have not found differences between infiltration (INF) and inferior alveolar nerve block (IANB) but current research is still conflicting.
Infiltration anesthesia is easier for the operator and more tolerable for the patient. Should it were sufficient for surgical procedures in the posterior mandible it could become the first option in routine surgeries.
The purpose of this prospective, randomized and multicenter study is to clarify the efficacy of infiltration anesthesia for placing implants in the posterior mandible.
The study will take place in eight centers with similar socio-professional characteristics and the same operative protocol. The study has been approved by the Ethical Research Committee of the University Hospital of San Juan (Alicante, Spain).
On a significant sample of patients (96n) that meet the in-exclusion criteria, the same intervention (implant placement surgery in posterior area of the mandible) has been carried out randomly (List Randomizer, www.random.org/lists) with one or another type of anesthesia (group A: IANB or group B: INF).
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, Investigator)
盲法说明
Patients were not told what type of anesthesia was being used and surgeons obtains the method of anesthesia to be used in this particular patient thirty minutes before intervention started.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient in health status American Society of Anesthesiologists (ASA) I and ASA II
- •Any age and gender
- •Unitary or multiple posterior mandibular edentulism.
- •Need to replace at least one implant and at least 2mm distal to mental foramen
- •Absence of orofacial neurological symptoms
排除标准
- •Any contraindication for implant surgery.
- •Hypersensitivity to any of the products used in the study
- •ASA patients ≦ II
- •Pharmacological allergies that contraindicate the intervention
- •Patients medicated with sedatives or analgesics up to 24h before the intervention
- •Psychotropic drug abuse or medication that may alter painful perception 15 days before the intervention
- •Pregnant or nursing women
- •Interventions with conscious sedation
- •Women on contraceptive treatment
- •Bisphosphonate-treated patients
- •Pathological mental state (dementia, psychosis)
- •Severe dental anxiety
- •Lack of collaboration
- •Signs of infection in the area to be operated
- •Unconventional surgical requirements (split crest, vertical regeneration, block graft, etc.)
结局指标
主要结局
Satisfaction of the Patient by Numerical Rating Scale
时间窗: Satisfaction of the patient 12 hours after surgery.
Patients satisfaction 12 hours after operation, being 0 not satisfied at all, and 10 very satisfied
Pain Perception by Numerical Rating Scale
时间窗: Pain perceived by the patient during surgery after the incision, the osteotomy and the suture
Pain perception by the patient during surgical procedure, being 0 no pain at all, 1-3 mild discomfort, 4-7 moderate pain and 7-10 intense pain
次要结局
未报告次要终点
研究者
Guillem Esteve-Pardo
Principal Investigator
Aula Dental Avanzada