Irreversible PulpitisPhase 4NCT01912755
Anesthetic Efficacy of Articaine and Lidocaine in Lower Molars With Irreversible Pulpits
A Phase 4 study testing 4% articaine with 1:100,000 epinephrine and 2% lidocaine with 1:100,000 epinephrine in people with Irreversible Pulpitis and Pain, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The aim of this study was to verify the effectiveness of an anesthetic called articaine for dental treatment, comparing it with an anesthetic commonly used in dental clinic: lidocaine. Two types of local anesthesia (oral injection) in accordance with the solution used were performed. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis, Pain
- What is being tested?
- 4% articaine with 1:100,000 epinephrine and 2% lidocaine with 1:100,000 epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2010to Jan 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- long-lasting moderate to severe pain during cold test
- absence of periapical radiolucency except for a widened periodontal ligament (evaluated in periapical radiographs)
- vital coronal pulp on access opening
Who cannot join
- Previous history of allergy to local anesthetics
- Subjects with systemic diseases
- Pregnancy and lactation
- Subjects taking any kind of medication that could change or influence the outcome of this research
- Subjects without painful symptoms
- Negative thermal testing, periapical lesion, incomplete root formation, presence of fistula or abscess, cracks or fractures
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Piracicaba Dental School - UNICAMP
Piracicaba, São Paulo, 13414-903
About this study
Official title: Anesthetic Efficacy of 4% Articaine (Mandibular Infiltration) and 2% Lidocaine (Alveolar Nerve Block), Associated With 1:100.000 Epinephrine, in Lower Molars With Irreversible Pulpits
The aim of this study was to verify the effectiveness of an anesthetic called articaine for dental treatment, comparing it with an anesthetic commonly used in dental clinic: lidocaine. Two types of local anesthesia (oral injection) in accordance with the solution used were performed. For patients anesthetized with articaine, an injection of anesthesia close to the tooth to be treated was used. For the anesthetic lidocaine an injection on the cheek at the bottom of the mouth was made. Differences between both techniques are mainly regarding the area of numbness. In the injection with articaine only a small part of the lip and the tooth was anesthetized. With lidocaine injection, the lower region of the entire side of the tooth and half of the tongue on the same side was numbed. The treatment was electronic randomized and there was equal chance to one or another treatment. The investigators are studying this new form of anesthesia (near the tooth that was treated) to see if it can numb the tooth to an emergency treatment, if it really decreases the feeling of numbness and discomfort during the service. Patients receiving articaine were submitted to cone beam exam at no cost.
Read the detailed description
Aim: This randomized clinical trial compared the anesthetic efficacy of buccal infiltration (BI) with 4% articaine (AR) and inferior alveolar nerve block (IANB) with 2% lidocaine (LI), both with 1:100,000 epinephrine, in symptomatic mandibular molars with irreversible pulpitis. Likewise, we compared the efficacy of the primary infiltration (BI or IANB) with one supplemental injection (intraligamentary infiltration with articaine for AR and BI with articaine for LI). The influences of buccal cortical bone thickness and root distances to buccal cortical bone on articaine performance (AR) were also evaluated using cone-beam tomography. methodology: Volunteers presenting symptomatic mandibular molars with irreversible pulpitis were randomly divided into two groups (30 for AR and 20 for LI). Success was recorded when complete pain-free treatment was achieved after primary injection or when one supplemental injection was needed for emergency endodontic procedures.
- Conditions
- Irreversible Pulpitis, Pain
- Being tested
- 4% articaine with 1:100,000 epinephrine, 2% lidocaine with 1:100,000 epinephrine
- Keywords
- Pulpitis, Hot tooth, Articaine, Lidocaine, Local anesthetics
- Medical subject headings
- Pain, Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% articaine with 1:100,000 epinephrineDrug
Also called articaine
If the primary anesthesia failed after ten minutes, an intraligamentary injection with 4% articaine with 1:100,000 epinephrine was performed and the procedure initiated. When access to the pulp chamber was available, intrapulpal anesthesia was given using 4% articaine with 1:100,000 epinephrine.
2% lidocaine with 1:100,000 epinephrineDrug
Also called Lidocaine
If the patient reported pain during treatment and access to the pulp chamber was not achieved, an IANB was performed with 2% lidocaine with 1:100,000 epinephrine.
| Study group | Role | What they receive |
|---|---|---|
| Articaine | Experimental | injection of 1.8 mL buccal infiltrations of 4% articaine with 1:100,000 epinephrine in one tooth with a clinical diagnosis of symptomatic irreversible pulpitis. Receives: Drug: 4% articaine with 1:100,000 epinephrine; Drug: 2% lidocaine with 1:100,000 epinephrine |
| Lidocaine | Active comparator | 1.8 mL 2% lidocaine with 1:100,000 epinephrine injected as inferior alveolar nerve block in the mandible side with one tooth with a clinical diagnosis of symptomatic irreversible pulpitis. Receives: Drug: 4% articaine with 1:100,000 epinephrine; Drug: 2% lidocaine with 1:100,000 epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception 3
Patients received visual analogue scales (VAS) to record their pain perception ten minutes after local anesthetic injection.
Measured: 10 minutes after injection
Secondary outcomes (4)
Buccal cortical bone thickness
Cone-beam computed tomography scans (iCat, Imaging Science, USA) were taken from patients submitted to articaine injection in order to measure the buccal cortical bone thickness.
Measured: one week after injection
Root distance to the bone
Cone-beam computed tomography scans (iCat, Imaging Science, USA) were taken from patients submitted to articaine injection in order to measure the the distance between the mesial and lingual roots to the buccal cortical bone.
Measured: one week after injection
Basal pain perception
Patients received visual analogue scales (VAS) to record their pain perception 10 min before the local anesthetic injection.
Measured: 10 minutes before injection
Pain perception 2
Patients received visual analogue scales (VAS) to record their pain perception 5 min before the local anesthetic injection (after the cold testing).
Measured: 5 minutes before injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startFeb 2010
- Primary completionNov 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Irreversible PulpitisStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Francisco Groppo, University of Campinas, Brazil
- Investigators
- José FA Almeida, DDS, PhD, Study chair, Endodontics Area - FOP-UNICAMPMaria RF Monteiro, DDS, MSc, Principal investigator, Endodontics Area - FOP-UNICAMP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912755
- Sponsor's protocol ID
- 2009-10834-4
- Other IDs
- 2009
- Status last verified
- May 2024
- First submitted
- 19 Jul 2013
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Aggarwal V, Jain A, Kabi D. Anesthetic efficacy of supplemental buccal and lingual infiltrations of articaine and lidocaine after an inferior alveolar nerve block in patients with irreversible pulpitis. J Endod. 2009 Jul;35(7):925-9. doi: 10.1016/j.joen.2009.04.012.
PubMed 19567309Ashraf H, Kazem M, Dianat O, Noghrehkar F. Efficacy of articaine versus lidocaine in block and infiltration anesthesia administered in teeth with irreversible pulpitis: a prospective, randomized, double-blind study. J Endod. 2013 Jan;39(1):6-10. doi: 10.1016/j.joen.2012.10.012. Epub 2012 Nov 13.
PubMed 23228249Berlin J, Nusstein J, Reader A, Beck M, Weaver J. Efficacy of articaine and lidocaine in a primary intraligamentary injection administered with a computer-controlled local anesthetic delivery system. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Mar;99(3):361-6. doi: 10.1016/j.tripleo.2004.11.009.
PubMed 15716846Monteiro MR, Groppo FC, Haiter-Neto F, Volpato MC, Almeida JF. 4% articaine buccal infiltration versus 2% lidocaine inferior alveolar nerve block for emergency root canal treatment in mandibular molars with irreversible pulpits: a randomized clinical study. Int Endod J. 2015 Feb;48(2):145-52. doi: 10.1111/iej.12293. Epub 2014 May 22.
PubMed 24702239
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Efficacy of 4% Articaine (Mandibular Infiltration) and 2% Lidocaine (Alveolar Nerve Block), Associated With 1:100.000 Epinephrine, in Lower Molars With Irreversible Pulpits
- ClinicalTrials.gov ID
- NCT01912755
- Acronym / sponsor ID
- 2009-10834-4
- Conditions
- Irreversible Pulpitis, Pain
- Keywords
- Pulpitis, Hot tooth, Articaine, Lidocaine, Local anesthetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 31 Jul 2013 (estimated)
- 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.
The aim of this study was to verify the effectiveness of an anesthetic called articaine for dental treatment, comparing it with an anesthetic commonly used in dental clinic: lidocaine. Two types of local anesthesia (oral injection) in accordance with the solution used were performed. For patients anesthetized with articaine, an injection of anesthesia close to the tooth to be treated was used. For the anesthetic lidocaine an injection on the cheek at the bottom of the mouth was made. Differences between both techniques are mainly regarding the area of numbness. In the injection with articaine only a small part of the lip and the tooth was anesthetized. With lidocaine injection, the lower region of the entire side of the tooth and half of the tongue on the same side was numbed. The treatment was electronic randomized and there was equal chance to one or another treatment. The investigators are studying this new form of anesthesia (near the tooth that was treated) to see if it can numb the tooth to an emergency treatment, if it really decreases the feeling of numbness and discomfort during the service. Patients receiving articaine were submitted to cone beam exam at no cost.
Detailed description
Aim: This randomized clinical trial compared the anesthetic efficacy of buccal infiltration (BI) with 4% articaine (AR) and inferior alveolar nerve block (IANB) with 2% lidocaine (LI), both with 1:100,000 epinephrine, in symptomatic mandibular molars with irreversible pulpitis. Likewise, we compared the efficacy of the primary infiltration (BI or IANB) with one supplemental injection (intraligamentary infiltration with articaine for AR and BI with articaine for LI). The influences of buccal cortical bone thickness and root distances to buccal cortical bone on articaine performance (AR) were also evaluated using cone-beam tomography. methodology: Volunteers presenting symptomatic mandibular molars with irreversible pulpitis were randomly divided into two groups (30 for AR and 20 for LI). Success was recorded when complete pain-free treatment was achieved after primary injection or when one supplemental injection was needed for emergency endodontic procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Articaine | Experimental | Drug: 4% articaine with 1:100,000 epinephrine, Drug: 2% lidocaine with 1:100,000 epinephrineinjection of 1.8 mL buccal infiltrations of 4% articaine with 1:100,000 epinephrine in one tooth with a clinical diagnosis of symptomatic irreversible pulpitis. |
| Lidocaine | Active comparator | Drug: 4% articaine with 1:100,000 epinephrine, Drug: 2% lidocaine with 1:100,000 epinephrine1.8 mL 2% lidocaine with 1:100,000 epinephrine injected as inferior alveolar nerve block in the mandible side with one tooth with a clinical diagnosis of symptomatic irreversible pulpitis. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- long-lasting moderate to severe pain during cold test
- absence of periapical radiolucency except for a widened periodontal ligament (evaluated in periapical radiographs)
- vital coronal pulp on access opening
Key exclusion criteria (6 listed)
- Previous history of allergy to local anesthetics
- Subjects with systemic diseases
- Pregnancy and lactation
- Subjects taking any kind of medication that could change or influence the outcome of this research
- Subjects without painful symptoms
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 |
|---|---|---|
| 4% articaine with 1:100,000 epinephrineAlso: articaineIf the primary anesthesia failed after ten minutes, an intraligamentary injection with 4% articaine with 1:100,000 epinephrine was performed and the procedure initiated. When access to the pulp chamber was available, intrapulpal anesthesia was given using 4% articaine with 1:100,000 epinephrine. | Drug | Articaine, Lidocaine |
| 2% lidocaine with 1:100,000 epinephrineAlso: LidocaineIf the patient reported pain during treatment and access to the pulp chamber was not achieved, an IANB was performed with 2% lidocaine with 1:100,000 epinephrine. | Drug | Articaine, Lidocaine |
Primary outcome
Pain perception 3
Time frame: 10 minutes after injection
Patients received visual analogue scales (VAS) to record their pain perception ten minutes after local anesthetic injection.
4 secondary outcomes
Buccal cortical bone thickness
Time frame: one week after injection
Root distance to the bone
Time frame: one week after injection
Basal pain perception
Time frame: 10 minutes before injection
Pain perception 2
Time frame: 5 minutes before injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 19567309Aggarwal V, Jain A, Kabi D. Anesthetic efficacy of supplemental buccal and lingual infiltrations of articaine and lidocaine after an inferior alveolar nerve block in patients with irreversible pulpitis. J Endod. 2009 Jul;35(7):925-9. doi: 10.1016/j.joen.2009.04.012.
- Background: PubMed 23228249Ashraf H, Kazem M, Dianat O, Noghrehkar F. Efficacy of articaine versus lidocaine in block and infiltration anesthesia administered in teeth with irreversible pulpitis: a prospective, randomized, double-blind study. J Endod. 2013 Jan;39(1):6-10. doi: 10.1016/j.joen.2012.10.012. Epub 2012 Nov 13.
- Background: PubMed 15716846Berlin J, Nusstein J, Reader A, Beck M, Weaver J. Efficacy of articaine and lidocaine in a primary intraligamentary injection administered with a computer-controlled local anesthetic delivery system. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Mar;99(3):361-6. doi: 10.1016/j.tripleo.2004.11.009.
- Derived from this study: PubMed 24702239Monteiro MR, Groppo FC, Haiter-Neto F, Volpato MC, Almeida JF. 4% articaine buccal infiltration versus 2% lidocaine inferior alveolar nerve block for emergency root canal treatment in mandibular molars with irreversible pulpits: a randomized clinical study. Int Endod J. 2015 Feb;48(2):145-52. doi: 10.1111/iej.12293. Epub 2014 May 22.
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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. This study is not recruiting at the moment.
José FA Almeida, DDS, PhD study chair
Endodontics Area - FOP-UNICAMP
Maria RF Monteiro, DDS, MSc principal investigator
Endodontics Area - FOP-UNICAMP
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 4% articaine with 1:100,000 epinephrine and 2% lidocaine with 1:100,000 epinephrine in people with Irreversible Pulpitis and Pain, run by University of Campinas, Brazil at 1 site in Brazil.
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 3 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: finished, as of the sponsor's last update on 8 May 2024. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception 3 (time frame: 10 minutes after injection). 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 NCT01912755, which also lists 4 linked publications.
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 8 May 2024.