- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07231614
Anesthetic Effectiveness of Lidocaine Versus Articaine in Dentistry
Anesthetic Effectiveness of Lidocaine Versus Articaine in Dentistry. A Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Natalia A Curín, Student
- Phone Number: +56947029930
- Email: natalia.curin@alumnos.uach.cl
Study Contact Backup
- Name: Camila A Henriquez, Student
- Phone Number: +56954911248
- Email: camilantonia.12345@gmail.com
Study Locations
-
-
Los Ríos Region
-
Valdivia, Los Ríos Region, Chile, 5090000
- CESFAM Dr. Jorge Sabat
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Lidocaine
Participant in this group will receive lidocaine as a local anesthetic during dental procedures.
|
Administration of lidocaine as a local anesthetic during dental extraction.
|
|
Experimental: Articaine
Participant in this group will receive articaine as a local anesthetic during dental procedures.
|
Administration of articaine as a local anesthetic during dental extraction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of tubes
Time Frame: immediately after the procedure
|
continuous quantitative variable
|
immediately after the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: After the procedure
|
Continuous quantitative variable
|
After the procedure
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age
Time Frame: immediately after the procedure
|
Continuous quantitative variable.
|
immediately after the procedure
|
|
Sex
Time Frame: Immediately after the procedure.
|
Nominal qualitative variable.
|
Immediately after the procedure.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Juan E Kunstmann, Dr. Dental Surgeon Dentistry, Universidad Austral de Chile
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Stomatognathic Diseases
- Tooth Diseases
- Facial Pain
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Toothache
- Sulfur Compounds
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Hydrocarbons
- Hydrocarbons, Cyclic
- Hydrocarbons, Aromatic
- Anilides
- Amides
- Aniline Compounds
- Amines
- Acetanilides
- Catechols
- Phenols
- Benzene Derivatives
- Alcohols
- Amino Alcohols
- Ethanolamines
- Thiophenes
- Biogenic Monoamines
- Biogenic Amines
- Catecholamines
- Lidocaine
- Epinephrine
- Carticaine
Other Study ID Numbers
- ArtiVsLido
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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