Symptomatic Irreversible PulpitisPhase 4NCT05227300

Buffered vs. Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis

A Phase 4 study testing Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution and 2% lidocaine with 1:100,000 epinephrine in people with Symptomatic Irreversible Pulpitis, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether one type of anesthetic (numbing medicine) will work better at numbing the nerve in a tooth than using a different type of anesthetic. A second purpose is to see if the time needed to numb the nerve in a tooth is different between the two anesthetics. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Symptomatic Irreversible Pulpitis
What is being tested?: Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution and 2% lidocaine with 1:100,000 epinephrine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 14 Feb 2022to 30 Jun 2022
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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

A negative response to cold in the proposed treatment tooth
A radiographic periradicular pathosis more advanced than a widened periodontal ligament or have an intraoral swelling

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University School of Dentistry Graduate Endodontics Dept.
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Buffered vs. Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis: A Controlled, Randomized Double-blind Study

Read the detailed description

40 subjects with a mandibular molar diagnosed with symptomatic irreversible pulpitis will be randomly allocated into 2 groups. One group will receive a total of 3 cartridges of a standard, unbuffered 2% lidocaine with 1:100,000 epinephrine via inferior alveolar nerve block (IANB) followed by supplemental buccal and lingual infiltrations, while the other will receive the equivalent yet buffered formulation. An electronic pulp tester (EPT) will be used to objectively determine baseline pulpal status of the affected tooth, followed by 2-minute interval testing following the administration of all local anesthesia. The onset of pulpal anesthesia is defined by the first of 2 consecutive EPT=80 readings, and the endodontic treatment may begin. Profound pulpal anesthesia is ultimately determined if the patients report a comfortable pulpotomy as reflected on the Wong-Baker FACES Visual Analog Scale.

Conditions: Symptomatic Irreversible Pulpitis
Being tested: Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution, 2% lidocaine with 1:100,000 epinephrine
Keywords: lidocaine, buffered, local anesthetic, irreversible pulpitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive SolutionDrug
Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic
2% lidocaine with 1:100,000 epinephrineDrug
Septodont's standard formulation of 2% lidocaine with epinephrine

Study groups in NCT05227300
Study group	Role	What they receive
Buffered 2% lidocaine with 1:100,000 epinephrine	Experimental	Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution) Receives: Drug: Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution; Drug: 2% lidocaine with 1:100,000 epinephrine
Unbuffered 2% lidocaine with 1:100,000 epinephrine	Active comparator	Standard local anesthetic Receives: 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.

VAS Scores as Measures of Profoundness of Pulpal Anesthesia
The mean Visual Analog Scale (VAS) score, which ranges from a min of 1 to a max of 10. In other words, inadequate anesthesia is considered to be a VAS score that is between 4 and 10 because that is not considered to be "comfortable and profound".
Measured: Up to 20 minutes post-drug administration

Secondary outcomes (1)

Onset of Pulpal Anesthesia
Duration of time in minutes required to achieve pulpal anesthesia, defined as an electrical pulp test score of 80 (which is the maximum stimulation). Any EPT score between 1-79 after 20 minutes post-anesthesia is considered a failure of pulpal anesthesia.
Measured: Up to 20 minutes post-drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 202230 Jun 2022

First posted7 Feb 2022
Study start14 Feb 2022
Primary completion23 May 2022
Study completion30 Jun 2022

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 (7)Papers the sponsor has linked to this study.
Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
More trials run by Indiana 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: Parallel groups
Model description: This study will be a single-center, controlled, randomized, double-blind (provider and subject), 2 treatment, 1 period, parallel study
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05227300
Sponsor's protocol ID: 11447
Status last verified: Apr 2024
First submitted: 7 Jan 2022
Last updated: 14 May 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Rosenberg PA, Amin KG, Zibari Y, Lin LM. Comparison of 4% articaine with 1:100,000 epinephrine and 2% lidocaine with 1:100,000 epinephrine when used as a supplemental anesthetic. J Endod. 2007 Apr;33(4):403-5. doi: 10.1016/j.joen.2006.11.019. Epub 2007 Feb 20.
PubMed 17368327
Goodis HE, Poon A, Hargreaves KM. Tissue pH and temperature regulate pulpal nociceptors. J Dent Res. 2006 Nov;85(11):1046-9. doi: 10.1177/154405910608501114.
PubMed 17062748
Christoph RA, Buchanan L, Begalla K, Schwartz S. Pain reduction in local anesthetic administration through pH buffering. Ann Emerg Med. 1988 Feb;17(2):117-20. doi: 10.1016/s0196-0644(88)80293-2.
PubMed 2827545
Schellenberg J, Drum M, Reader A, Nusstein J, Fowler S, Beck M. Effect of Buffered 4% Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind Study. J Endod. 2015 Jun;41(6):791-6. doi: 10.1016/j.joen.2015.02.022. Epub 2015 Apr 1.
PubMed 25841959
Saatchi M, Farhad AR, Shenasa N, Haghighi SK. Effect of Sodium Bicarbonate Buccal Infiltration on the Success of Inferior Alveolar Nerve Block in Mandibular First Molars with Symptomatic Irreversible Pulpitis: A Prospective, Randomized Double-blind Study. J Endod. 2016 Oct;42(10):1458-61. doi: 10.1016/j.joen.2016.07.004. Epub 2016 Aug 6.
PubMed 27507627
Fowler S, Reader A. Is a volume of 3.6 mL better than 1.8 mL for inferior alveolar nerve blocks in patients with symptomatic irreversible pulpitis? J Endod. 2013 Aug;39(8):970-2. doi: 10.1016/j.joen.2013.04.007. Epub 2013 May 16.
PubMed 23880260
Kanaa MD, Whitworth JM, Meechan JG. A prospective randomized trial of different supplementary local anesthetic techniques after failure of inferior alveolar nerve block in patients with irreversible pulpitis in mandibular teeth. J Endod. 2012 Apr;38(4):421-5. doi: 10.1016/j.joen.2011.12.006. Epub 2012 Feb 2.
PubMed 22414822

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
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Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
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Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
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All Symptomatic Irreversible Pulpitis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Buffered vs. Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis: A Controlled, Randomized Double-blind Study
ClinicalTrials.gov ID: NCT05227300
Acronym / sponsor ID: 11447
Conditions: Symptomatic Irreversible Pulpitis
Keywords: lidocaine, buffered, local anesthetic, irreversible pulpitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Study start: 14 Feb 2022 (actual)
Primary completion: 23 May 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 7 Feb 2022 (actual)
Results: Posted 14 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: This study will be a single-center, controlled, randomized, double-blind (provider and subject), 2 treatment, 1 period, parallel study

Arm	Type	Receives
Buffered 2% lidocaine with 1:100,000 epinephrine	Experimental	Drug: Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution, Drug: 2% lidocaine with 1:100,000 epinephrineBuffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution)
Unbuffered 2% lidocaine with 1:100,000 epinephrine	Active comparator	Drug: 2% lidocaine with 1:100,000 epinephrineStandard local anesthetic

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (2 listed)

A negative response to cold in the proposed treatment tooth
A radiographic periradicular pathosis more advanced than a widened periodontal ligament or have an intraoral swelling

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
Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive SolutionOnpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic	Drug	Buffered 2% lidocaine with 1:100,000 epinephrine
2% lidocaine with 1:100,000 epinephrineSeptodont's standard formulation of 2% lidocaine with epinephrine	Drug	Buffered 2% lidocaine with 1:100,000 epinephrine, Unbuffered 2% lidocaine with 1:100,000 epinephrine

Primary outcome

VAS Scores as Measures of Profoundness of Pulpal Anesthesia
Time frame: Up to 20 minutes post-drug administration
The mean Visual Analog Scale (VAS) score, which ranges from a min of 1 to a max of 10. In other words, inadequate anesthesia is considered to be a VAS score that is between 4 and 10 because that is not considered to be "comfortable and profound".

1 secondary outcome

Onset of Pulpal Anesthesia
Time frame: Up to 20 minutes post-drug administration

Results and safety

Results posted to the registry on 14 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Buffered 2% Lidocaine With 1:100,000 Epinephrine	20	20
Unbuffered 2% Lidocaine With 1:100,000 Epinephrine	20	20

Primary outcome: VAS Scores as Measures of Profoundness of Pulpal Anesthesia

Time frame: Up to 20 minutes post-drug administration. Mean (Full Range). Unit: Score on a scale

Measure	Buffered 2% Lidocaine With 1:100,000 Epinephrine n = 20	Unbuffered 2% Lidocaine With 1:100,000 Epinephrine n = 20
Value	3.1 (0 to 8)	1.2 (0.0 to 7)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3.5 month enrollment period; each patient's data was collected at a single treatment appointment within the specified enrollment period; each of these appointments last on average 3 hours.. Other adverse events reported at 0.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Buffered 2% Lidocaine With 1:100,000 Epinephrine	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Unbuffered 2% Lidocaine With 1:100,000 Epinephrine	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): With a total sample size of 40 (20 subjects per group), this study has an 80% power to detect a difference between 90% and 50% of subjects who achieve profound pulpal anesthesia. Increasing the sample size to include a larger number of subjects per group would also increase the power and ultimately the level of statistical significance between those groups.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17368327Rosenberg PA, Amin KG, Zibari Y, Lin LM. Comparison of 4% articaine with 1:100,000 epinephrine and 2% lidocaine with 1:100,000 epinephrine when used as a supplemental anesthetic. J Endod. 2007 Apr;33(4):403-5. doi: 10.1016/j.joen.2006.11.019. Epub 2007 Feb 20.
Background: PubMed 17062748Goodis HE, Poon A, Hargreaves KM. Tissue pH and temperature regulate pulpal nociceptors. J Dent Res. 2006 Nov;85(11):1046-9. doi: 10.1177/154405910608501114.
Background: PubMed 2827545Christoph RA, Buchanan L, Begalla K, Schwartz S. Pain reduction in local anesthetic administration through pH buffering. Ann Emerg Med. 1988 Feb;17(2):117-20. doi: 10.1016/s0196-0644(88)80293-2.
Background: PubMed 25841959Schellenberg J, Drum M, Reader A, Nusstein J, Fowler S, Beck M. Effect of Buffered 4% Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind Study. J Endod. 2015 Jun;41(6):791-6. doi: 10.1016/j.joen.2015.02.022. Epub 2015 Apr 1.
Background: PubMed 27507627Saatchi M, Farhad AR, Shenasa N, Haghighi SK. Effect of Sodium Bicarbonate Buccal Infiltration on the Success of Inferior Alveolar Nerve Block in Mandibular First Molars with Symptomatic Irreversible Pulpitis: A Prospective, Randomized Double-blind Study. J Endod. 2016 Oct;42(10):1458-61. doi: 10.1016/j.joen.2016.07.004. Epub 2016 Aug 6.
Background: PubMed 23880260Fowler S, Reader A. Is a volume of 3.6 mL better than 1.8 mL for inferior alveolar nerve blocks in patients with symptomatic irreversible pulpitis? J Endod. 2013 Aug;39(8):970-2. doi: 10.1016/j.joen.2013.04.007. Epub 2013 May 16.
Background: PubMed 22414822Kanaa MD, Whitworth JM, Meechan JG. A prospective randomized trial of different supplementary local anesthetic techniques after failure of inferior alveolar nerve block in patients with irreversible pulpitis in mandibular teeth. J Endod. 2012 Apr;38(4):421-5. doi: 10.1016/j.joen.2011.12.006. Epub 2012 Feb 2.
Individual participant dataSharing planned: No

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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?

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 0 inclusion and 2 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 14 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 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 14 May 2024). 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?

VAS Scores as Measures of Profoundness of Pulpal Anesthesia (time frame: Up to 20 minutes post-drug administration). 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 NCT05227300, which also lists 7 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 14 May 2024.