AnesthesiaPhase 4NCT02054767
Anesthetic Efficacy in Irreversible Pulpitis
A Phase 4 study testing Intervention: inferior alveolar nerve block injection in people with Anesthesia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study was to compare the anesthetic efficacy of articaine, lidocaine and mepivacaine in patients with irreversible pulpitis of mandibular molar. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Intervention: inferior alveolar nerve block injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Jul 2013
- 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
- clinical diagnosis of irreversible pulpitis
- good health
- had at least 1 adjacent tooth plus a healthy canine
Who cannot join
- took medication could be interacting with any of the anesthetics used
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Emergency Center of the School of Dentistry at the University of São Paulo
São Paulo, São Paulo, 05508-900
About this study
Official title: Anesthetic Efficacy of Articaine, Lidocaine and Mepivacaine in Patients With Irreversible Pulpitis of Mandibular Molar
The purpose of this study was to compare the anesthetic efficacy of articaine, lidocaine and mepivacaine in patients with irreversible pulpitis of mandibular molar.
Read the detailed description
Conventional inferior alveolar nerve block (IANB) is the most commonly used technique for achieving pulpal anesthesia in posterior mandibular endodontic procedures. However, IANB has a high failure rate and success rates are even lower when applied for the treatment of mandibular posterior teeth with irreversible pulpitis.
- Conditions
- Anesthesia
- Being tested
- Intervention: inferior alveolar nerve block injection
- Keywords
- articaine, lidocaine, mepivacaine, inferior alveolar nerve block, irreversible pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: inferior alveolar nerve block injectionDrug
-22 patients received inferior alveolar nerve block injections of 3.6 mL (equivalent to 2 cartridges)
| Study group | Role | What they receive |
|---|---|---|
| lidocaine | Experimental | injections of 3.6 mL of 2% lidocaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection Receives: Drug: Intervention: inferior alveolar nerve block injection |
| mepivacaine | Experimental | injections of 3.6 mL of 2% mepivacaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection Receives: Drug: Intervention: inferior alveolar nerve block injection |
| articaine | Experimental | injections of 3.6 mL of 4% articaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection Receives: Drug: Intervention: inferior alveolar nerve block injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulpal anesthesia
pulpal anesthesia was tested with an electric pulp stimulator
Measured: Ten minutes after the inferior alveolar nerve block
Secondary outcomes (1)
analgesia
To evaluate the intensity of pain during the pulpectomy a verbal analogic scale was adopted
Measured: the patients were instructed to report any painful sensation at three phases: 1) dentin 2) pulp chamber 3) root canal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startAug 2010
- Primary completionNov 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Peixoto Tortamano, University of Sao Paulo
- Investigators
- Isabel P Tortamano, PhD, Principal investigator, USão Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054767
- Sponsor's protocol ID
- FDAAA
- Status last verified
- Sep 2013
- First submitted
- 3 Sep 2013
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Efficacy of Articaine, Lidocaine and Mepivacaine in Patients With Irreversible Pulpitis of Mandibular Molar
- ClinicalTrials.gov ID
- NCT02054767
- Acronym / sponsor ID
- FDAAA
- Conditions
- Anesthesia
- Keywords
- articaine, lidocaine, mepivacaine, inferior alveolar nerve block, irreversible pulpitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Feb 2014 (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 purpose of this study was to compare the anesthetic efficacy of articaine, lidocaine and mepivacaine in patients with irreversible pulpitis of mandibular molar.
Detailed description
Conventional inferior alveolar nerve block (IANB) is the most commonly used technique for achieving pulpal anesthesia in posterior mandibular endodontic procedures. However, IANB has a high failure rate and success rates are even lower when applied for the treatment of mandibular posterior teeth with irreversible pulpitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lidocaine | Experimental | Drug: Intervention: inferior alveolar nerve block injectioninjections of 3.6 mL of 2% lidocaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection |
| mepivacaine | Experimental | Drug: Intervention: inferior alveolar nerve block injectioninjections of 3.6 mL of 2% mepivacaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection |
| articaine | Experimental | Drug: Intervention: inferior alveolar nerve block injectioninjections of 3.6 mL of 4% articaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- clinical diagnosis of irreversible pulpitis
- good health
- had at least 1 adjacent tooth plus a healthy canine
Key exclusion criteria (1 listed)
- took medication could be interacting with any of the anesthetics used
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 |
|---|---|---|
| Intervention: inferior alveolar nerve block injection-22 patients received inferior alveolar nerve block injections of 3.6 mL (equivalent to 2 cartridges) | Drug | articaine, lidocaine, mepivacaine |
Primary outcome
pulpal anesthesia
Time frame: Ten minutes after the inferior alveolar nerve block
pulpal anesthesia was tested with an electric pulp stimulator
1 secondary outcome
analgesia
Time frame: the patients were instructed to report any painful sensation at three phases: 1) dentin 2) pulp chamber 3) root canal
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 4 Feb 2014.
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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.
Isabel P Tortamano, PhD principal investigator
USão Paulo
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 Intervention: inferior alveolar nerve block injection in people with Anesthesia, run by University of Sao Paulo 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 1 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 4 Feb 2014. 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?
pulpal anesthesia (time frame: Ten minutes after the inferior alveolar nerve block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2014.