NCT05804630

Efficacy and Safety of Articaine and Lidocaine in Extraction of Wisdom Teeth of Upper and Lower Jaws

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Local anesthesia drugs and anesthesia technique play an imperative role in dental treatment. The purpose of this study was to compare the efficacy and safety of different dental local anesthetics drugs and brands in clinical use for the extraction of wisdom teeth.

Detailed description

Local anesthesia drugs and anesthesia technique play an imperative role in dental treatment. They are widely used in oral and maxillofacial surgery, endodontic treatment, periodontal treatment, prosthetics and operative dentistry. They not only reduce the pain of the patient during the treatment, but also improve the comfort of the treatment. The most commonly used local anesthetics are Lidocaine and Articaine, whose efficacy and safety have been demonstrated in many literatures: fast-acting, effective in pain control, comfortable, relatively rare allergic reaction, few local and systemic adverse effects. Among the above-mentioned drugs, Articaine is an anesthetic drug that has been developed and become popular in recent years. In the past, literature pointed out that due to the relationship between the drug concentration and structure of Articaine, its ability to penetrate into bone is better than that of Lidocaine. Some studies even believe that local infiltration with Articaine can replace block anesthesia with Lidocaine; which means, on the one hand, it is more comfortable during anesthesia. On the other hand, it can avoid the potential adverse effects of block anesthesia, such as: hematoma formation and systemic adverse effects caused by intravascular injection. For exodontia surgery, a quite common surgery for general dentists and oral surgeons, the most commonly used anesthesia techniques are local infiltration and block anesthesia. The purpose of this study was to compare the efficacy and safety of different dental local anesthetics drugs and brands in clinical use for the extraction of impacted wisdom teeth. Three types of local anesthetics that have been widely used and proven safe were included: 1. Xylestesin-A® (1.7mL/cartridge contains 20mg/mL Lidocaine + 1:80,000 epinephrine) 2. Octocaine® (1.8mL/cartridge contains 20mg/mL Lidocaine + 1:100,000 epinephrine) 3. Orabloc® (1.8mL/cartridge contains 40mg/mL Articaine + 1:100,000 epinephrine) This study will be a randomized split-mouth clinical study, and it will include 60 healthy adult patients aged between 20-60 years old, who are evaluated by a single surgeon to be suitable for extraction or odontectomy of their impacted third molars (upper or lower jaws) under local anesthesia. This study consists of two experiments. The above 60 patients will be randomly assigned to group 1 or 2, using different anesthetic drugs or anesthesia techniques: 1. Group 1: Octocaine® block vs. Xylestesin-A® block 2. Group 2: Orabloc® infiltration vs. Octocaine ® block During the treatment, we will record the patient's subjective anesthesia onset time, the physician's objective anesthesia onset time, the patient's pain scale during surgery, comfort assessment, adverse reactions, postoperative paresthesia, etc. to evaluate the efficacy and safety of these drugs and anesthesia technique.

Conditions

• Wisdom Tooth
• Dental Impaction

Interventions

Type	Name	Description
DRUG	Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)	As mentioned in arm/group descriptions. The amount of dental anesthetic agents used during the surgery will be tailored for patient according to their response, which will not exceed the recommended dosage described in the instruction of the product. The amount of the drug used during the surgery will be recorded.

Timeline

• Start date: 2023-03-15
• Primary completion: 2024-01-31
• Completion: 2024-07-31
• First posted: 2023-04-07
• Last updated: 2023-04-07

Locations

1 site across 1 country: Taiwan