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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Active Comparator | Participant in this group will receive lidocaine as a local anesthetic during dental procedures. |
|
| Articaine | Experimental | Participant in this group will receive articaine as a local anesthetic during dental procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine + epinephrine 1:100,000 | Drug | Administration of lidocaine as a local anesthetic during dental extraction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of tubes | continuous quantitative variable | immediately after the procedure |
| 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. | Continuous quantitative variable | After the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Continuous quantitative variable. | immediately after the procedure |
| Sex | Nominal qualitative variable. | Immediately after the procedure. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalia A CurÃn, Student | Contact | +56947029930 | natalia.curin@alumnos.uach.cl | |
| Camila A Henriquez, Student | Contact | +56954911248 | camilantonia.12345@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Juan E Kunstmann, Dr. Dental Surgeon Dentistry | Universidad Austral de Chile | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CESFAM Dr. Jorge Sabat | Valdivia | Los RÃos Region | 5090000 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29742264 | Result | 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. |
| Label | URL |
|---|---|
| Document that describes in detail the objectives, methodology, and procedures of the clinical trial. | View source |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 17, 2025 | Aug 19, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014098 | Toothache |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D004837 | Epinephrine |
| D002355 | Carticaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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.
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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.
| Articaine 4% with epinephrine 1:100,000 | Drug | Administration of articaine as a local anesthetic during dental extraction. |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |