Compare Articaine 1:100.000, 4% Epinephrine, Subperiosteal With Loco-regional Anesthesia for Placing Dental Implants in Posterior Mandible - Double-Blinded Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Anesthesia efficiency
研究概览
简要总结
In patients that are going to receive a dental implant in the posterior mandible (distal from canine), does the subperiosteal anesthetic technique with Articaine 1:100.000 4 % Epinephrine compared to the loco-regional one, produces the same analgesia during surgery ?
详细描述
Inter/Intra observer agreement will be made for administration of local subperiosteal, loco-regional anesthesia, operatory evaluation of pain and radiologic examination.
One group will receive articaine 1:100.000, 4% epinephrine subperiosteal and the other 1:100.000 4% epinephrine loco-regional for dental implant installation in posterior mandible.
The evaluation parameters will focus on intraoperatory pain, Intraoperatory anesthetic complications, anesthetic efficiency, correlation between distance from implant to inferior alveolar nerve, intraoperatory pain, post-operatory at 3 and 10 days and correlate changes, and survival rate of dental implants during and post osseointegration period.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Single unit implant rehabilitation
- •Maxilla and mandible
- •Must accept treatment plan
- •Must sign informed consent
- •dental extraction performed at least 3 month prior
- •Must have at least 6 mm of residual bone
- •Absence of oral lesions
- •keratinized tissue must be present
排除标准
- •If smoking and/or other drug addiction is present
- •If local anesthetic allergy is present
- •Patient subjected to chemical or radiotherapy
- •if Hepatic disease is present
- •If immunodepression is present
- •If Pregnancy is present
- •If Diabetes is present
- •If Heart disease is present
研究组 & 干预措施
Subepriosteal Articaine
Administer Subperiosteal 1:100.000 Articaine 4% epinephrine, buccal and lingually, for Dental Implants in Posterior mandible
干预措施: Dental Implants in Posterior Mandible (Device)
Loco-regional Articaine
Administer Loco-regional 1:100.000 articaine 4% epinephrine, for Dental Implants in Posterior Mandible
干预措施: Dental Implants in Posterior Mandible (Device)
结局指标
主要结局
Anesthesia efficiency
时间窗: During Surgery for Dental Implant installation
Evaluate subperiosteal vs loco-regional anesthesia for implant installation in posterior mandible. It will be measured by the amount (mean) of anesthesia pre and intraoperatory
次要结局
- Intraoperatory Anesthesia Complications(During Surgery for implant installation in posterior mandible)
- Time of Surgery(During Surgical Procedure)
- Intraoperatory Pain(During Surgery for Implant Installation in posterior mandible)
- Distance To Inferior Alveolar Nerve (IAN)(Post operative Panoramic radiograph)
- Post-Operatory Outcome Changes(Baseline (T0) 3 Days (T1) 10 Days (T2))
研究者
Andre Chen
Msc
Implantology Institute