Combination of Buffered Anesthetic to Treat Mandibular Molars

NCT06047366 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 17799
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Symptomatic Irreversible Pulpitis

Keywords

lidocaine; articaine; mepivacaine; buffered local anesthetic; irreversible pulpitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 20 minutes post-drug administration

Secondary Outcomes (1)

• Median Time to Profound Pulpal Anesthesia

  Up to 15 minutes post-drug administration

Study Arms (2)

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)

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

Drug: Lidocaine w/ epi; Drug: Articaine w/ epi; Drug: Mepivacaine plain

Interventions

Sodium bicarbonate DRUG

Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic

Also known as: Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solutio

Buffered

Lidocaine w/ epi DRUG

Septodont's standard formulation of 2% lidocaine with epinephrine

Also known as: 2% lidocaine with 1:100,000 epinephrine

Buffered; Unbuffered

Articaine w/ epi DRUG

Septodont's standard formulation of 4% articaine with epinephrine

Also known as: 4% articaine with 1:100,000 epinephrine

Buffered; Unbuffered

Mepivacaine plain DRUG

Septodont's standard formulation of 3% mepivacaine

Also known as: 3% Mepivacaine

Buffered; Unbuffered

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

ndiana University School of Dentistry Graduate Endodontics Dept.

Indianapolis, Indiana, 46202, United States

Location

Related Publications (7)

• 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.

  PMID: 17368327 BACKGROUND

• 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.

  PMID: 17062748 BACKGROUND

• 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.

  PMID: 2827545 BACKGROUND

• 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.

  PMID: 25841959 BACKGROUND

• 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.

  PMID: 27507627 BACKGROUND

• 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.

  PMID: 23880260 BACKGROUND

• 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.

  PMID: 22414822 BACKGROUND

MeSH Terms

Interventions

Sodium Bicarbonate; Epinephrine; Lidocaine; Carticaine; Mepivacaine

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Results Point of Contact

• Title: Dr. Ken Spolnik
• Organization: Indiana University School of Dentistry

kspolnik@iu.edu

317-274-7280

Study Officials

• Kenneth Spolnik, DDS

  Program Director

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: A statistician will provide a two-product randomization scheme which will randomize each of the 60 subjects on the order of their entry into the study. The research assistants will be aware of and document this scheme, but the student researcher/PI will not know what type of anesthetic will be administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Endodontics Chair

Model Details: This study will be a single-center, controlled, randomized, double-blind (provider and subject), 2 treatment, 1 period, parallel study

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: December 5, 2023
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)