NCT05804630

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

April 7, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

February 13, 2023

Last Update Submit

March 27, 2023

Conditions

Wisdom ToothDental Impaction

Keywords

Dental anesthesiaLidocaineArticaineWisdom toothThird molarImpaction

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Adverse events of anesthesia

    Recorded during and interview the patient immediate after each dental extraction surgery

Study Arms (4)

Experiment 1, arm 1: Articaine infiltration anesthesia

ACTIVE COMPARATOR

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®)

Experiment 1, arm 2: Lidocaine block anesthesia

ACTIVE COMPARATOR

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®)

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

ACTIVE COMPARATOR

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®)

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

ACTIVE COMPARATOR

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®)

Interventions

Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)DRUG

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.

Experiment 1, arm 1: Articaine infiltration anesthesiaExperiment 1, arm 2: Lidocaine block anesthesiaExperiment 2, arm 1: Lidocaine+1:100000 adrenaline block anesthesiaExperiment 2, arm 2: Lidocaine+1:80000 adrenaline block anesthesia

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dentistry National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (6)

  • 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.

    PMID: 17656135BACKGROUND

  • 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.

    PMID: 10832257BACKGROUND

  • 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.

    PMID: 15793381BACKGROUND

  • 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.

    PMID: 18358883BACKGROUND

  • 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.

    PMID: 16554198BACKGROUND

  • 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.

    PMID: 16997112BACKGROUND

MeSH Terms

Conditions

Tooth, Impacted

Interventions

CarticaineLidocaine

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

April 7, 2023

Study Start

March 15, 2023

Primary Completion

January 31, 2024

Study Completion

July 31, 2024

Last Updated

April 7, 2023

Record last verified: 2023-01

Locations

TW(1)