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

NCT05227300 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 11447
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Symptomatic Irreversible Pulpitis

Keywords

lidocaine; buffered; local anesthetic; irreversible pulpitis

Outcome Measures

Primary Outcomes (1)

• 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".

  Up to 20 minutes post-drug administration

Secondary Outcomes (1)

• Onset of Pulpal Anesthesia

  Up to 20 minutes post-drug administration

Study Arms (2)

Buffered 2% lidocaine with 1:100,000 epinephrine

EXPERIMENTAL

Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution)

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

Drug: 2% lidocaine with 1:100,000 epinephrine

Interventions

Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution DRUG

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

Buffered 2% lidocaine with 1:100,000 epinephrine

2% lidocaine with 1:100,000 epinephrine DRUG

Septodont's standard formulation of 2% lidocaine with epinephrine

Buffered 2% lidocaine with 1:100,000 epinephrine; Unbuffered 2% lidocaine with 1:100,000 epinephrine

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)

Indiana 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

Lidocaine; Epinephrine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

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.

Results Point of Contact

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

kspolnik@iu.edu

317-274-7280

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 40 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: January 7, 2022
• First Posted: February 7, 2022
• Study Start: February 14, 2022
• Primary Completion: May 23, 2022
• Study Completion: June 30, 2022
• Last Updated: May 14, 2024
• Results First Posted: May 14, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)