NCT07231614

Brief Summary

Context: Lidocaine and articaine are two of the most commonly used local anesthetics in dentistry. Lidocaine has often been the anesthetic of choice in clinical practice, but in clinical experience, articaine has proven to be more effective in controlling pain during dental procedures. (Camps-Font, O. et al. 2020). There are still unanswered questions, such as which of the two local anesthetics is more effective in reducing pain? This could lead us to discuss which one to choose to reduce costs in the dental office. Objective: The objective of this project is to determine and compare the effectiveness of lidocaine and articaine in clinical contexts such as tooth extraction with infiltrative techniques, seeking to provide answers that will optimize the choice of anesthetic based on the patient and the procedure, thus improving pain management and reducing costs in the dental office. Design: Randomized double-blind experimental study, parallel groups. The control group received 2% lidocaine, and the experimental group received 4% articaine. The study will be conducted in accordance with the guidelines of the Consolidated Standards of Reporting Trials (CONSORT 2010). The probabilistic sampling technique is through simple randomization. The 100 patients who meet the inclusion criteria will be randomly assigned to the control and experimental groups in a 1:1 ratio. Expected results: articaine shows a lower percentage of extractions with anesthetic reinforcement and, therefore, a lower average number of additional tubes.

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
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

August 27, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

December 20, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2026

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

5 days

First QC Date

August 27, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

nerve blockcomparative studyexodonticspain measurementanesthesia infiltration

Outcome Measures

Primary Outcomes (1)

  • Number of tubes

    continuous quantitative variable

    immediately after the procedure

Secondary Outcomes (1)

  • Pain during dislocation using the Visual Analog Scale (VAS) for pain with a minimum of 0 meaning no pain, and a maximum of 10 meaning the most severe pain ever experienced in life.

    After the procedure

Other Outcomes (2)

  • Age

    immediately after the procedure

  • Sex

    Immediately after the procedure.

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Participant in this group will receive lidocaine as a local anesthetic during dental procedures.

Drug: lidocaine + epinephrine 1:100,000

Articaine

EXPERIMENTAL

Participant in this group will receive articaine as a local anesthetic during dental procedures.

Drug: Articaine 4% with epinephrine 1:100,000

Interventions

Administration of lidocaine as a local anesthetic during dental extraction.

Lidocaine

Administration of articaine as a local anesthetic during dental extraction.

Articaine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with clinical indications for simple extraction of upper and lower teeth using infiltrative anesthetic techniques.
  • Patients without systemic diseases (ASA I)
  • Patients with controlled systemic disease (ASA II)
  • Patients with no history of hypersensitivity to anesthetics or their components (epinephrine)
  • Patients with stable periodontal condition, without active infection that could affect the diffusion of the anesthetic.
  • Patients with the ability to understand the procedure and provide informed consent.

You may not qualify if:

  • Patients with uncontrolled systemic diseases ASA III and pregnant patients.
  • Patients requiring trunk techniques (Gow gates, Spix, Carrea)
  • Patients taking medication that affects the anesthetic response (tricyclic antidepressants, anticoagulants)
  • Patients with a history of neurological or psychiatric disorders that may influence the perception of pain or anxiety.
  • Patients with anatomical abnormalities in the orofacial region that interfere with the administration or action of anesthesia.
  • Patients with a history of recent substance abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CESFAM Dr. Jorge Sabat

Valdivia, Los Ríos Region, 5090000, Chile

Location

Related Publications (1)

  • Halabi D, Escobar J, Alvarado C, Martinez N, Munoz C. Chlorhexidine for prevention of alveolar osteitis: a randomised clinical trial. J Appl Oral Sci. 2018;26:e20170245. doi: 10.1590/1678-7757-2017-0245. Epub 2018 May 7.

Related Links

MeSH Terms

Conditions

Toothache

Interventions

LidocaineEpinephrineCarticaine

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsThiophenesSulfur CompoundsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Juan E Kunstmann, Dr. Dental Surgeon Dentistry

    Universidad Austral de Chile

    STUDY DIRECTOR

Central Study Contacts

Natalia A Curín, Student

CONTACT

Camila A Henriquez, Student

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Blinding will be performed by the study investigators. The RCT is a double-blind trial, where neither the operator nor the patient knows the result of the anesthesia being administered. The preparation of the intervention will be carried out by dividing the anesthetic cartridges, 50 for the control group (lidocaine) and 50 for the experimental group (articaine). Since both articaine and lidocaine are from the same manufacturer, they have the same color silicone plunger, so we will simply cover the logo with an adhesive sticker and store them in a box. To distinguish which of the tubes corresponds to articaine or lidocaine once they have the sticker, they will be assigned the same numbers that will be used to randomize each patient (1 and 2 interleaved), with No. 1 being articaine and No. 2 being lidocaine. These will be in their respective boxes with their numbering.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, parallel-group experimental study. Control group: 2% lidocaine; experimental group: 4% articaine. The RCT will be conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT 2010) guidelines.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2025

First Posted

November 17, 2025

Study Start

December 20, 2025

Primary Completion

December 25, 2025

Study Completion

January 25, 2026

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) collected during the trial, including demographic information, medical history relevant to the inclusion/exclusion criteria, type of anesthetic administered, and study outcome measures, will be available for secondary analyses.

Locations