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

Study Overview
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Brief Summary
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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
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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: Xylestesin-A® (1.7mL/cartridge contains 20mg/mL Lidocaine + 1:80,000 epinephrine) Octocaine® (1.8mL/cartridge contains 20mg/mL Lidocaine + 1:100,000 epinephrine) 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: Group 1: Octocaine® block vs. Xylestesin-A® block 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.

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

Conditions
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Wisdom Tooth, Dental Impaction

Intervention / Treatment
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* Drug: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged between 20-60 years old Generally healthy or with well-controlled mild systemic diseases (such as well-controlled hypertension, diabetes, or hyperlipidemia) Bilateral wisdom teeth with similar difficulty of surgery(according to Pell and Gregory and Winter's classification), which are indicated for surgical removal under local anesthesia Exclusion Criteria: Known or suspected allergy to amide-type local anesthetic agents With systemic contraindication for tooth extraction, such as poorly-controlled heart diseases or diabetes, and severe liver or kidney diseases. Patients with systolic blood pressure greater than 150 mmHg or less than 90 mmHg or diastolic blood pressure greater than 100 mmHg or less than 60 mmHg are also excluded With local contraindication for tooth extraction, such as previous irradiation to the surgical region, acute infection or cellulitis at the surgical region Patients during pregnancy or lactation Patients taking analgesic or sedatives in 24 hrs Intolerant of dental extraction surgery under local anesthesia due to anxiety, dentophobia, or pain

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Split-mouth study design: one dental anesthetic agent at one side (left or right) of mouth and another agent at the other (left or right) side of mouth
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experiment 1, arm 1: Articaine infiltration anesthesia<br>This arm aims to compare efficacy and safety of infiltration anesthesia of Articaine (Orabloc®) to block anesthesia of Lidocaine (Octocaine®). It would be a split-mouth study design. The patient in this arm would be randomly assigned to one anesthetic agent and technique at one side (left or right) of the wisdom tooth surgery first, and the other side (left or right) of wisdom tooth surgery would use the other anesthetic agent and technique accordingly. | Drug: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)<br>* 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.<br>|
| Active Comparator: Experiment 1, arm 2: Lidocaine block anesthesia<br>This arm aims to compare efficacy and safety of infiltration anesthesia of Articaine (Orabloc®) to block anesthesia of Lidocaine (Octocaine®). It would be a split-mouth study design. The patient in this arm would be randomly assigned to one anesthetic agent and technique at one side (left or right) of the wisdom tooth surgery first, and the other side (left or right) of wisdom tooth surgery would use the other anesthetic agent and technique accordingly. | Drug: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)<br>* 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.<br>|
| Active Comparator: Experiment 2, arm 1: Lidocaine+1:100000 adrenaline block anesthesia<br>This arm aims to compare efficacy and safety of block anesthesia of Lidocaine containing different concentration of epinephrine (adrenaline), i.e. Octocaine® (Lidocaine+1:100000 adrenaline) vs. Xylestesin-A® (Lidocaine+1:80000 adrenaline). It would be a split-mouth study design. The patients in this arm would be randomly assigned to one anesthetic agent at one side (left or right) of the wisdom tooth surgery first, and the other side (left or right) of wisdom tooth surgery would use the other anesthetic agent accordingly. | Drug: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)<br>* 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.<br>|
| Active Comparator: Experiment 2, arm 2: Lidocaine+1:80000 adrenaline block anesthesia<br>This arm aims to compare efficacy and safety of block anesthesia of Lidocaine containing different concentration of epinephrine (adrenaline), i.e. Octocaine® (Lidocaine+1:100000 adrenaline) vs. Xylestesin-A® (Lidocaine+1:80000 adrenaline). It would be a split-mouth study design. The patients in this arm would be randomly assigned to one anesthetic agent at one side (left or right) of the wisdom tooth surgery first, and the other side (left or right) of wisdom tooth surgery would use the other anesthetic agent accordingly. | Drug: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic measures | Including heart rate (HR) | Recorded immediate before local anesthesia, immediate after local anesthesia, 5 minutes after local anesthesia and immediate after surgery | 
| Hemodynamic measures | Blood pressure (Systolic pressure and diastolic pressure) | Recorded immediate before local anesthesia, immediate after local anesthesia, 5 minutes after local anesthesia and immediate after surgery | 
| O2 saturation (SpO2) | O2 saturation (SpO2) | Recorded immediate before local anesthesia, immediate after local anesthesia, 5 minutes after local anesthesia and immediate after surgery | 
| Pain and satisfaction of the surgery | Pain according to VAS (0-10) and satisfaction score (1-5, 1 being the least satisfactory and 5 being the most satisfactory) | Recorded immediate after each dental extraction surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events of anesthesia | Such as headache, dizziness, nausea, vomiting, tachycardia, dyspnea, or post-operative neurosensory disturbance | Recorded during and interview the patient immediate after each dental extraction surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental anesthesia, Lidocaine, Articaine, Wisdom tooth, Third molar, Impaction