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

Primary Purpose

Wisdom Tooth, Dental Impaction

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wisdom Tooth focused on measuring Dental anesthesia, Lidocaine, Articaine, Wisdom tooth, Third molar, Impaction

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Dentistry National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Experiment 1, arm 1: Articaine infiltration anesthesia

Experiment 1, arm 2: Lidocaine block anesthesia

Experiment 2, arm 1: Lidocaine+1:100000 adrenaline block anesthesia

Experiment 2, arm 2: Lidocaine+1:80000 adrenaline block anesthesia

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Hemodynamic measures
Including heart rate (HR)
Hemodynamic measures
Blood pressure (Systolic pressure and diastolic pressure)
O2 saturation (SpO2)
O2 saturation (SpO2)
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)

Secondary Outcome Measures

Adverse events of anesthesia
Such as headache, dizziness, nausea, vomiting, tachycardia, dyspnea, or post-operative neurosensory disturbance

Full Information

First Posted
February 13, 2023
Last Updated
March 27, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05804630
Brief Title
Efficacy and Safety of Articaine and Lidocaine in Extraction of Wisdom Teeth of Upper and Lower Jaws
Official Title
Efficacy and Safety of Articaine and Lidocaine in Extraction of Wisdom Teeth of Upper and Lower Jaws
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wisdom Tooth, Dental Impaction
Keywords
Dental anesthesia, Lidocaine, Articaine, Wisdom tooth, Third molar, Impaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experiment 1, arm 1: Articaine infiltration anesthesia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experiment 1, arm 2: Lidocaine block anesthesia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experiment 2, arm 1: Lidocaine+1:100000 adrenaline block anesthesia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experiment 2, arm 2: Lidocaine+1:80000 adrenaline block anesthesia
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemodynamic measures
Description
Including heart rate (HR)
Time Frame
Recorded immediate before local anesthesia, immediate after local anesthesia, 5 minutes after local anesthesia and immediate after surgery
Title
Hemodynamic measures
Description
Blood pressure (Systolic pressure and diastolic pressure)
Time Frame
Recorded immediate before local anesthesia, immediate after local anesthesia, 5 minutes after local anesthesia and immediate after surgery
Title
O2 saturation (SpO2)
Description
O2 saturation (SpO2)
Time Frame
Recorded immediate before local anesthesia, immediate after local anesthesia, 5 minutes after local anesthesia and immediate after surgery
Title
Pain and satisfaction of the surgery
Description
Pain according to VAS (0-10) and satisfaction score (1-5, "1" being the least satisfactory and "5" being the most satisfactory)
Time Frame
Recorded immediate after each dental extraction surgery
Secondary Outcome Measure Information:
Title
Adverse events of anesthesia
Description
Such as headache, dizziness, nausea, vomiting, tachycardia, dyspnea, or post-operative neurosensory disturbance
Time Frame
Recorded during and interview the patient immediate after each dental extraction surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Dentistry National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17656135
Citation
Liau FL, Kok SH, Lee JJ, Kuo RC, Hwang CR, Yang PJ, Lin CP, Kuo YS, Chang HH. Cardiovascular influence of dental anxiety during local anesthesia for tooth extraction. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Jan;105(1):16-26. doi: 10.1016/j.tripleo.2007.03.015. Epub 2007 Jul 25.
Results Reference
background
PubMed Identifier
10832257
Citation
Malamed SF, Gagnon S, Leblanc D. Efficacy of articaine: a new amide local anesthetic. J Am Dent Assoc. 2000 May;131(5):635-42. doi: 10.14219/jada.archive.2000.0237.
Results Reference
background
PubMed Identifier
15793381
Citation
Mikesell P, Nusstein J, Reader A, Beck M, Weaver J. A comparison of articaine and lidocaine for inferior alveolar nerve blocks. J Endod. 2005 Apr;31(4):265-70. doi: 10.1097/01.don.0000140576.36513.cb.
Results Reference
background
PubMed Identifier
18358883
Citation
Evans G, Nusstein J, Drum M, Reader A, Beck M. A prospective, randomized, double-blind comparison of articaine and lidocaine for maxillary infiltrations. J Endod. 2008 Apr;34(4):389-93. doi: 10.1016/j.joen.2008.01.004. Epub 2008 Feb 7.
Results Reference
background
PubMed Identifier
16554198
Citation
Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine and lidocaine mandibular buccal infiltration anesthesia: a prospective randomized double-blind cross-over study. J Endod. 2006 Apr;32(4):296-8. doi: 10.1016/j.joen.2005.09.016. Epub 2006 Feb 17.
Results Reference
background
PubMed Identifier
16997112
Citation
Lai TN, Lin CP, Kok SH, Yang PJ, Kuo YS, Lan WH, Chang HH. Evaluation of mandibular block using a standardized method. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Oct;102(4):462-8. doi: 10.1016/j.tripleo.2005.12.003. Epub 2006 Jun 8.
Results Reference
background

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

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