Anesthetic EffectivenessPhase 4NCT01567839
Testing the Anesthetic Effectiveness of Three Different Dental Local Anesthetics Injected Next to a Lower First Molar
A Phase 4 study testing Mandibular buccal Infiltration injection in people with Anesthetic Effectiveness, run by Ohio State University at 1 site in United States.
Trial summary
Infiltration (injecting next to the tooth) injections are common in dentistry and a number of studies have shown that articaine anesthetic, when injected next to the tooth as a supplemental injection, works very well following a typical inferior alveolar (lower jaw) nerve block. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthetic Effectiveness
- What is being tested?
- Mandibular buccal Infiltration injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to May 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- between the ages of 18 and 65 years.
- in good health (ASA classification II or lower).
- able to provide informed consent.
Who cannot join
- allergy to articaine, lidocaine or prilocaine.
- history of significant medical problems (ASA classification III or greater).
- depression (taking tri-cyclic antidepressant medications to control).
- have taken CNS depressants (including alcohol or any analgesic medications) within the last 48 hours prior to testing.
- lactating or pregnant.
- inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Dentistry, Postle Hall
Columbus, Ohio, 43210
About this study
Official title: Anesthetic Efficacy of 4% Articaine With 1:100,000 Epinephrine, 4% Prilocaine With 1:200,000 Epinephrine, and 4% Lidocaine With 1:100,000 Epinephrine as a Primary Buccal Infiltration in the Mandibular First Molar.
Infiltration (injecting next to the tooth) injections are common in dentistry and a number of studies have shown that articaine anesthetic, when injected next to the tooth as a supplemental injection, works very well following a typical inferior alveolar (lower jaw) nerve block. No study has compared 4% articaine with 1:100,000 epinephrine, 4% prilocaine with 1:200,000 epinephrine, and 4% lidocaine with 1:100,000 epinephrine in mandibular (lower jaw) infiltration injections of the first molar. The purpose of this prospective, randomized, double-blind, crossover study is to compare the degree of anesthesia obtained from the three solutions as a primary infiltration injection next to the mandibular first molar. The investigators also will record the pain of injection and postoperative pain.
Read the detailed description
Using a crossover design, 60 adult subjects will receive three injections consisting of a primary mandibular first molar infiltration of 1.8 mL of 4% articaine with 1:100,000 epinephrine, 1.8 mL of 4% prilocaine with 1:200,000 epinephrine, and 1.8 mL of 4% lidocaine with 1:100,000 epinephrine in three separate appointments spaced at least one week apart. With the crossover design, 180 infiltrations will be given for the first molar and each subject will serve as his or her own control. Ninety infiltrations will be administered on the mandibular left side and ninety administered on the mandibular right side. The order of the three injections will be assigned randomly and the dentist and subject will be blinded about which anesthetic the subject is given. The anesthetics used in this study are not experimental. An electric pulp tester will be used to test the lower back teeth (molars and premolars) for anesthesia in 3-minute time intervals for a total of 60 minutes. The pain of injection and postoperative pain will be recorded in a survey. The data will be statistically analyzed.
- Conditions
- Anesthetic Effectiveness
- Being tested
- Mandibular buccal Infiltration injection
- Keywords
- degree of pulpal anesthesia obtained, primary infiltration in the lower first molar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular buccal Infiltration injectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 4% Lidocaine | Experimental | 1.8 mL of 4% lidocaine with 1:100,000 epinephrine Receives: Procedure: Mandibular buccal Infiltration injection |
| 4% Articaine | Experimental | 1.8 mL of 4% articaine with 1:100,000 epinephrine Receives: Procedure: Mandibular buccal Infiltration injection |
| 4% Prilocaine | Experimental | 1.8 mL of 4% prilocaine with 1:200,000 epinephrine Receives: Procedure: Mandibular buccal Infiltration injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Pulpal Anesthesia.
Two consecutive 80/80 readings (no patient response) during 60 minutes of testing with an electric pulp tester.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anesthetic EffectivenessStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Nusstein, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567839
- Sponsor's protocol ID
- 4% dental local anesthetics
- Status last verified
- Nov 2013
- First submitted
- 28 Mar 2012
- Last updated
- 1 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine buccal infiltration enhances the effectiveness of lidocaine inferior alveolar nerve block. Int Endod J. 2009 Mar;42(3):238-46. doi: 10.1111/j.1365-2591.2008.01507.x.
PubMed 19228214Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine and lidocaine mandibular buccal infiltration anesthesia: a prospective randomized double-blind cross-over study. J Endod. 2006 Apr;32(4):296-8. doi: 10.1016/j.joen.2005.09.016. Epub 2006 Feb 17.
PubMed 16554198Robertson D, Nusstein J, Reader A, Beck M, McCartney M. The anesthetic efficacy of articaine in buccal infiltration of mandibular posterior teeth. J Am Dent Assoc. 2007 Aug;138(8):1104-12. doi: 10.14219/jada.archive.2007.0324.
PubMed 17670879Haase A, Reader A, Nusstein J, Beck M, Drum M. Comparing anesthetic efficacy of articaine versus lidocaine as a supplemental buccal infiltration of the mandibular first molar after an inferior alveolar nerve block. J Am Dent Assoc. 2008 Sep;139(9):1228-35. doi: 10.14219/jada.archive.2008.0338.
PubMed 18762633Corbett IP, Kanaa MD, Whitworth JM, Meechan JG. Articaine infiltration for anesthesia of mandibular first molars. J Endod. 2008 May;34(5):514-8. doi: 10.1016/j.joen.2008.02.042.
PubMed 18436027Abdulwahab M, Boynes S, Moore P, Seifikar S, Al-Jazzaf A, Alshuraidah A, Zovko J, Close J. The efficacy of six local anesthetic formulations used for posterior mandibular buccal infiltration anesthesia. J Am Dent Assoc. 2009 Aug;140(8):1018-24. doi: 10.14219/jada.archive.2009.0313.
PubMed 19654255
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Efficacy of 4% Articaine With 1:100,000 Epinephrine, 4% Prilocaine With 1:200,000 Epinephrine, and 4% Lidocaine With 1:100,000 Epinephrine as a Primary Buccal Infiltration in the Mandibular First Molar.
- ClinicalTrials.gov ID
- NCT01567839
- Acronym / sponsor ID
- 4% dental local anesthetics
- Conditions
- Anesthetic Effectiveness
- Keywords
- degree of pulpal anesthesia obtained, primary infiltration in the lower first molar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Posted 1 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infiltration (injecting next to the tooth) injections are common in dentistry and a number of studies have shown that articaine anesthetic, when injected next to the tooth as a supplemental injection, works very well following a typical inferior alveolar (lower jaw) nerve block. No study has compared 4% articaine with 1:100,000 epinephrine, 4% prilocaine with 1:200,000 epinephrine, and 4% lidocaine with 1:100,000 epinephrine in mandibular (lower jaw) infiltration injections of the first molar. The purpose of this prospective, randomized, double-blind, crossover study is to compare the degree of anesthesia obtained from the three solutions as a primary infiltration injection next to the mandibular first molar. The investigators also will record the pain of injection and postoperative pain.
Detailed description
Using a crossover design, 60 adult subjects will receive three injections consisting of a primary mandibular first molar infiltration of 1.8 mL of 4% articaine with 1:100,000 epinephrine, 1.8 mL of 4% prilocaine with 1:200,000 epinephrine, and 1.8 mL of 4% lidocaine with 1:100,000 epinephrine in three separate appointments spaced at least one week apart. With the crossover design, 180 infiltrations will be given for the first molar and each subject will serve as his or her own control. Ninety infiltrations will be administered on the mandibular left side and ninety administered on the mandibular right side. The order of the three injections will be assigned randomly and the dentist and subject will be blinded about which anesthetic the subject is given. The anesthetics used in this study are not experimental. An electric pulp tester will be used to test the lower back teeth (molars and premolars) for anesthesia in 3-minute time intervals for a total of 60 minutes. The pain of injection and postoperative pain will be recorded in a survey. The data will be statistically analyzed.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4% Lidocaine | Experimental | Procedure: Mandibular buccal Infiltration injection1.8 mL of 4% lidocaine with 1:100,000 epinephrine |
| 4% Articaine | Experimental | Procedure: Mandibular buccal Infiltration injection1.8 mL of 4% articaine with 1:100,000 epinephrine |
| 4% Prilocaine | Experimental | Procedure: Mandibular buccal Infiltration injection1.8 mL of 4% prilocaine with 1:200,000 epinephrine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between the ages of 18 and 65 years.
- in good health (ASA classification II or lower).
- able to provide informed consent.
Key exclusion criteria (6 listed)
- allergy to articaine, lidocaine or prilocaine.
- history of significant medical problems (ASA classification III or greater).
- depression (taking tri-cyclic antidepressant medications to control).
- have taken CNS depressants (including alcohol or any analgesic medications) within the last 48 hours prior to testing.
- lactating or pregnant.
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 |
|---|---|---|
| Mandibular buccal Infiltration injection | Procedure or surgery | 4% Articaine, 4% Lidocaine, 4% Prilocaine |
Primary outcome
Successful Pulpal Anesthesia.
Time frame: 60 minutes
Two consecutive 80/80 readings (no patient response) during 60 minutes of testing with an electric pulp tester.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19228214Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine buccal infiltration enhances the effectiveness of lidocaine inferior alveolar nerve block. Int Endod J. 2009 Mar;42(3):238-46. doi: 10.1111/j.1365-2591.2008.01507.x.
- Background: PubMed 16554198Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine and lidocaine mandibular buccal infiltration anesthesia: a prospective randomized double-blind cross-over study. J Endod. 2006 Apr;32(4):296-8. doi: 10.1016/j.joen.2005.09.016. Epub 2006 Feb 17.
- Background: PubMed 17670879Robertson D, Nusstein J, Reader A, Beck M, McCartney M. The anesthetic efficacy of articaine in buccal infiltration of mandibular posterior teeth. J Am Dent Assoc. 2007 Aug;138(8):1104-12. doi: 10.14219/jada.archive.2007.0324.
- Background: PubMed 18762633Haase A, Reader A, Nusstein J, Beck M, Drum M. Comparing anesthetic efficacy of articaine versus lidocaine as a supplemental buccal infiltration of the mandibular first molar after an inferior alveolar nerve block. J Am Dent Assoc. 2008 Sep;139(9):1228-35. doi: 10.14219/jada.archive.2008.0338.
- Background: PubMed 18436027Corbett IP, Kanaa MD, Whitworth JM, Meechan JG. Articaine infiltration for anesthesia of mandibular first molars. J Endod. 2008 May;34(5):514-8. doi: 10.1016/j.joen.2008.02.042.
- Background: PubMed 19654255Abdulwahab M, Boynes S, Moore P, Seifikar S, Al-Jazzaf A, Alshuraidah A, Zovko J, Close J. The efficacy of six local anesthetic formulations used for posterior mandibular buccal infiltration anesthesia. J Am Dent Assoc. 2009 Aug;140(8):1018-24. doi: 10.14219/jada.archive.2009.0313.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mandibular buccal Infiltration injection in people with Anesthetic Effectiveness, run by Ohio State University at 1 site in United States.
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 1 Jan 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 United States. 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?
Yes. Results are posted in the registry (first posted 1 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Successful Pulpal Anesthesia. (time frame: 60 minutes). 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 NCT01567839, which also lists 6 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 1 Jan 2014.