Dental PainPhase 4NCT07231614
Anesthetic Effectiveness of Lidocaine Versus Articaine in Dentistry
A Phase 4 study testing lidocaine + epinephrine 1:100,000 and Articaine 4% with epinephrine 1:100,000 in people with Dental Pain, run by Universidad Austral de Chile at 1 site in Chile.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pain
- What is being tested?
- lidocaine + epinephrine 1:100,000 and Articaine 4% with epinephrine 1:100,000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChile
- Study dates
- 20 Dec 2025to 25 Jan 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Conditions
- Dental Pain
- Being tested
- lidocaine + epinephrine 1:100,000, Articaine 4% with epinephrine 1:100,000
- Keywords
- nerve block, comparative study, exodontics, pain measurement, anesthesia infiltration
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine + epinephrine 1:100,000Drug
Administration of lidocaine as a local anesthetic during dental extraction.
Articaine 4% with epinephrine 1:100,000Drug
Administration of articaine as a local anesthetic during dental extraction.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Participant in this group will receive lidocaine as a local anesthetic during dental procedures. Receives: Drug: lidocaine + epinephrine 1:100,000 |
| Articaine | Experimental | Participant in this group will receive articaine as a local anesthetic during dental procedures. Receives: Drug: Articaine 4% with epinephrine 1:100,000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of tubes
continuous quantitative variable
Measured: 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.
Continuous quantitative variable
Measured: After the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start20 Dec 2025 (estimated)
- Primary completion25 Dec 2025 (estimated)
- Study completion25 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Austral de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan E Kunstmann, Dr. Dental Surgeon Dentistry, Study director, Universidad Austral de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231614
- Sponsor's protocol ID
- ArtiVsLido
- Status last verified
- Nov 2025
- First submitted
- 27 Aug 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 29742264
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Effectiveness of Lidocaine Versus Articaine in Dentistry. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07231614
- Acronym / sponsor ID
- ArtiVsLido
- Conditions
- Dental Pain
- Keywords
- nerve block, comparative study, exodontics, pain measurement, anesthesia infiltration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Austral de ChileUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 25 Jan 2026 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: lidocaine + epinephrine 1:100,000Participant in this group will receive lidocaine as a local anesthetic during dental procedures. |
| Articaine | Experimental | Drug: Articaine 4% with epinephrine 1:100,000Participant in this group will receive articaine as a local anesthetic during dental procedures. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine + epinephrine 1:100,000Administration of lidocaine as a local anesthetic during dental extraction. | Drug | Lidocaine |
| Articaine 4% with epinephrine 1:100,000Administration of articaine as a local anesthetic during dental extraction. | Drug | Articaine |
Primary outcome
Number of tubes
Time frame: immediately after the procedure
continuous quantitative variable
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 29742264Halabi 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.
- Document that describes in detail the objectives, methodology, and procedures of the clinical trial.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan E Kunstmann, Dr. Dental Surgeon Dentistry study director
Universidad Austral de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lidocaine + epinephrine 1:100,000 and Articaine 4% with epinephrine 1:100,000 in people with Dental Pain, run by Universidad Austral de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia A Curín, Student (+56947029930, natalia.curin@alumnos.uach.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of tubes (time frame: immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07231614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.