Symptomatic Irreversible PulpitisPhase 4NCT06047366
Combination of Buffered Anesthetic to Treat Mandibular Molars
A Phase 4 study testing Sodium bicarbonate, Lidocaine w/ epi and Articaine w/ epi in people with Symptomatic Irreversible Pulpitis, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a combination of anesthetics (numbing medicine) will adequately anesthetize teeth over a different combination. 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?
- Sodium bicarbonate, Lidocaine w/ epi and Articaine w/ epi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2023to 15 May 2024
- Phase
- Phase 4
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
- Be between the ages of 18 and 80 years old
- Have the ability and willingness to independently consent to treatment and study participation
- Have an uncomplicated medical history (ASA I and II)
- Not be pregnant
- Have no allergies local anesthetics/sulfites (confirmed or self-reported)
- Not be taking any medications that may affect the proper assessment of the anesthetic (no acetaminophen or short-acting NSAIDs such as ibuprofen within the previous 6 hours; no long-acting NSAIDs such as naproxen within the previous 16 hours)
- Not require nitrous oxide during treatment, and the injection area should appear healthy with no other pre-existing conditions or infections that may compromise an accurate collection of data
- Be experiencing signs of irreversible pulpitis (an exaggerated response to cold that lingers longer than 10 seconds) in a mandibular molar at the time of conducting the study
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
ndiana University School of Dentistry Graduate Endodontics Dept.
Indianapolis, Indiana, 46202
About this study
Official title: Buffered vs Unbuffered Local Anesthesia Using Lidocaine, Carbocaine, and Articaine in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis
The purpose of this study is to determine whether a combination of anesthetics (numbing medicine) will adequately anesthetize teeth over a different combination. A second purpose is to see if the time needed to numb the nerve in a tooth is different between the two anesthetics.
Read the detailed description
60 human subjects with Symptomatic Irreversible Pulpitis (SIP) in mandibular molars will be randomly allocated into 2 groups. One group will receive a combination of: 1 cartridge of buffered 2% lidocaine w/ 1:100k epi via inferior alveolar nerve block (IANB) followed by 1 cartridge of 3% mepivacaine via IANB. This will be followed by 0.5 cartridges (0.9mL) of buffered 4% articaine with 1:100k epi via buccal infiltration and 0.5 cartridges of buffered 4% articaine with 1:100k epi via lingual infiltration. All IANB injections will include a lingual block. The second group will be provided an unbuffered version of the same combination. An electronic pulp tester (EPT) will be used to determine the vitality of the treated tooth. Endodontic treatment will be initiated after two consecutive EPT readings of 80, displaying pulpal anesthesia. Profound pulpal anesthesia is described by the patient's report on the visual analog scale after the pulpotomy.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Sodium bicarbonate, Lidocaine w/ epi, Articaine w/ epi, Mepivacaine plain
- Keywords
- lidocaine, articaine, mepivacaine, buffered local anesthetic, irreversible pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDrug
Also called Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solutio
Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic
Lidocaine w/ epiDrug
Also called 2% lidocaine with 1:100,000 epinephrine
Septodont's standard formulation of 2% lidocaine with epinephrine
Articaine w/ epiDrug
Also called 4% articaine with 1:100,000 epinephrine
Septodont's standard formulation of 4% articaine with epinephrine
Mepivacaine plainDrug
Also called 3% Mepivacaine
Septodont's standard formulation of 3% mepivacaine
| Study group | Role | What they receive |
|---|---|---|
| Buffered | Experimental | Buffered 2% lidocaine with 1:100,000 epinephrine Buffered 4% articaine with 1:100,000 epinephrine Buffered 3% mepivacaine Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution) Receives: Drug: Sodium bicarbonate; Drug: Lidocaine w/ epi; Drug: Articaine w/ epi; Drug: Mepivacaine plain |
| Unbuffered | Active comparator | Unbuffered 2% lidocaine with 1:100,000 epinephrine Unbuffered 4% articaine with 1:100,000 epinephrine Unbuffered 3% mepivacaine Standard local anesthetics Receives: Drug: Lidocaine w/ epi; Drug: Articaine w/ epi; Drug: Mepivacaine plain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Visual Analogue Scale (VAS) Score as a Measure of Profoundness of Pulpal Anesthesia
Patient will report their comfort during treatment based on a visual analogue scale (VAS) graphic. Visual analog scale (VAS) is based on a scale of 0-10 related to patient comfort. A VAS score of 10 would mean the patient was extremely uncomfortable during treatment indicating there was inadequate anesthesia. A VAS score of 0 indicates no pain.
Measured: Up to 20 minutes post-drug administration
Secondary outcomes (1)
Median Time to Profound Pulpal Anesthesia
An electronic pulp tester will be used to assess anesthesia after anesthetic is administered. The median time needed to achieve profound pulpal anesthesia for the two groups will be calculated using the Kaplan-Meier method and compared with a log-rank test, with patients who failed to achieve profound pulpal anesthesia censored at 15 minutes.
Measured: Up to 15 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.
- First posted21 Sep 2023
- Study start5 Dec 2023
- Primary completion15 May 2024
- Study completion15 May 2024
Why it stopped: Student PI is preparing for graduation and cannot complete the study as planned.
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.
- 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)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth J. Spolnik DDS, Indiana University
- Investigators
- Kenneth Spolnik, DDS, Study chair, Program Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047366
- Sponsor's protocol ID
- 17799
- Status last verified
- May 2025
- First submitted
- 14 Sep 2023
- Last updated
- 13 May 2025
- 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 17368327Goodis 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 17062748Christoph 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 2827545Schellenberg 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 25841959Saatchi 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 27507627Fowler 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 23880260Kanaa 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