Anesthetic EffectivenessPhase 4NCT01862614
Testing the Anesthetic Effectiveness of Buffered Articaine Injected Next to a Lower First Molar.
A Phase 4 study testing Articaine Hydrochloride + Epinephrine and Buffered Articaine Hydrochloride + Epinephrine 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 a lower molar, is more effective than a local anesthetic injection of lidocaine. However success rates have not been as high as hoped for. 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?
- Articaine Hydrochloride + Epinephrine and Buffered Articaine Hydrochloride + Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to May 2014
- 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 age of 18-65 years.
- in good health (ASA classification II or higher).
- able to provide informed consent.
Who cannot join
- allergy to articaine.
- history of significant medical problems (ASA classification of III or worse).
- diagnosed depression (taking tri-cyclic antidepressant medications to control).
- have taken central nervous system (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: A Prospective Randomized, Double-blind Study of the Anesthetic Efficacy of Buffered Articaine as a Primary Buccal Infiltration of 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 a lower molar, is more effective than a local anesthetic injection of lidocaine. However success rates have not been as high as hoped for. No objective study has addressed the success rate of buffering articaine in a mandibular primary buccal infiltration of the first molar. Therefore, the purpose of this prospective, randomized, double-blind, crossover study is to compare the degree of pulpal anesthesia obtained with a buffered 4% articaine with 1:100,000 epinephrine solution versus a non-buffered 4% articaine with 1:100,000 epinephrine solution as a primary infiltration in the mandibular first molar. The investigators will also record the pain of injection and postoperative pain.
Read the detailed description
Using a crossover design, 80 adult subjects will receive two injections consisting of a primary mandibular first molar infiltration of 1.8 mL of non-buffered 4% articaine with 1:100,000 epinephrine, and 1.8 mL of buffered 4% articaine with 1:100,000 in two separate appointments spaced at least one week apart. With the crossover design, 160 infiltrations will be given for the first molar and each subject will serve as his or her own control. Eighty infiltrations will be administered on the mandibular left side and 80 administered on the mandibular right side. The order of the two 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 (EPT) will be used to test the lower first molar for anesthesia starting 30 seconds after the injection; and testing every 30 seconds for the first five minutes. After five minutes the EPT will be used to test the lower first molar every minute and the contralateral control canine every 5 minutes for a grand total of sixty minutes. The pain of injection and postoperative pain will be recorded in a survey. Patients will report any postoperative pain or discomfort on a Visual Analog Scale (VAS) for three days following each appointment. The data will be statistically analyzed.
- Conditions
- Anesthetic Effectiveness
- Being tested
- Articaine Hydrochloride + Epinephrine, Buffered Articaine Hydrochloride + Epinephrine
- Keywords
- Degree of pulpal anesthesia obtained., Primary infiltration in the lower first molar., Buffered local anesthetic.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articaine Hydrochloride + EpinephrineDrug
Buffered Articaine Hydrochloride + EpinephrineDrug
| Study group | Role | What they receive |
|---|---|---|
| Buffered Articaine at 1st Appointment | Experimental | Subjects received an infiltration injection of 1.8cc buffered 4% articaine. Receives: Drug: Buffered Articaine Hydrochloride + Epinephrine |
| Articaine at 1st Appointment | Active comparator | Subjects received an infiltration injection of 1.8cc 4% articaine (unbuffered). Receives: Drug: Articaine Hydrochloride + Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Pulpal Anesthesia.
An electric pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success.
Measured: 60 minutes per injection sequence.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2014
- Study completionMay 2014
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 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
- NCT01862614
- Sponsor's protocol ID
- Buffered Articaine
- Status last verified
- May 2021
- First submitted
- 22 May 2013
- Last updated
- 26 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kanaa 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 17670879Corbett 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 19654255Sinnott CJ, Garfield JM, Thalhammer JG, Strichartz GR. Addition of sodium bicarbonate to lidocaine decreases the duration of peripheral nerve block in the rat. Anesthesiology. 2000 Oct;93(4):1045-52. doi: 10.1097/00000542-200010000-00028.
PubMed 11020760Burmeister CH. A practical method for the extemporaneous preparations of a buffered anesthetic solution. J Am Dent Assoc 22:1514, 1935.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized, Double-blind Study of the Anesthetic Efficacy of Buffered Articaine as a Primary Buccal Infiltration of the Mandibular First Molar.
- ClinicalTrials.gov ID
- NCT01862614
- Acronym / sponsor ID
- Buffered Articaine
- Conditions
- Anesthetic Effectiveness
- Keywords
- Degree of pulpal anesthesia obtained., Primary infiltration in the lower first molar., Buffered local anesthetic.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Posted 2 Dec 2020
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 a lower molar, is more effective than a local anesthetic injection of lidocaine. However success rates have not been as high as hoped for. No objective study has addressed the success rate of buffering articaine in a mandibular primary buccal infiltration of the first molar. Therefore, the purpose of this prospective, randomized, double-blind, crossover study is to compare the degree of pulpal anesthesia obtained with a buffered 4% articaine with 1:100,000 epinephrine solution versus a non-buffered 4% articaine with 1:100,000 epinephrine solution as a primary infiltration in the mandibular first molar. The investigators will also record the pain of injection and postoperative pain.
Detailed description
Using a crossover design, 80 adult subjects will receive two injections consisting of a primary mandibular first molar infiltration of 1.8 mL of non-buffered 4% articaine with 1:100,000 epinephrine, and 1.8 mL of buffered 4% articaine with 1:100,000 in two separate appointments spaced at least one week apart. With the crossover design, 160 infiltrations will be given for the first molar and each subject will serve as his or her own control. Eighty infiltrations will be administered on the mandibular left side and 80 administered on the mandibular right side. The order of the two 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 (EPT) will be used to test the lower first molar for anesthesia starting 30 seconds after the injection; and testing every 30 seconds for the first five minutes. After five minutes the EPT will be used to test the lower first molar every minute and the contralateral control canine every 5 minutes for a grand total of sixty minutes. The pain of injection and postoperative pain will be recorded in a survey. Patients will report any postoperative pain or discomfort on a Visual Analog Scale (VAS) for three days following each appointment. The data will be statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buffered Articaine at 1st Appointment | Experimental | Drug: Buffered Articaine Hydrochloride + EpinephrineSubjects received an infiltration injection of 1.8cc buffered 4% articaine. |
| Articaine at 1st Appointment | Active comparator | Drug: Articaine Hydrochloride + EpinephrineSubjects received an infiltration injection of 1.8cc 4% articaine (unbuffered). |
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 age of 18-65 years.
- in good health (ASA classification II or higher).
- able to provide informed consent.
Key exclusion criteria (6 listed)
- allergy to articaine.
- history of significant medical problems (ASA classification of III or worse).
- diagnosed depression (taking tri-cyclic antidepressant medications to control).
- have taken central nervous system (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 |
|---|---|---|
| Articaine Hydrochloride + Epinephrine | Drug | Articaine at 1st Appointment |
| Buffered Articaine Hydrochloride + Epinephrine | Drug | Buffered Articaine at 1st Appointment |
Primary outcome
Number of Participants Achieving Pulpal Anesthesia.
Time frame: 60 minutes per injection sequence.
An electric pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 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.
- Background: PubMed 11020760Sinnott CJ, Garfield JM, Thalhammer JG, Strichartz GR. Addition of sodium bicarbonate to lidocaine decreases the duration of peripheral nerve block in the rat. Anesthesiology. 2000 Oct;93(4):1045-52. doi: 10.1097/00000542-200010000-00028.
- BackgroundBurmeister CH. A practical method for the extemporaneous preparations of a buffered anesthetic solution. J Am Dent Assoc 22:1514, 1935.
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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 Articaine Hydrochloride + Epinephrine and Buffered Articaine Hydrochloride + Epinephrine 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 26 May 2021. 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 2 Dec 2020). 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?
Number of Participants Achieving Pulpal Anesthesia. (time frame: 60 minutes per injection sequence.). 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 NCT01862614, 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 26 May 2021.