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

Primary Purpose

Symptomatic Irreversible Pulpitis

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

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

2% lidocaine with 1:100,000 epinephrine

About this trial

This is an interventional treatment trial for Symptomatic Irreversible Pulpitis focused on measuring lidocaine, buffered, local anesthetic, irreversible pulpitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria - In order to participate, subjects must:

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

Exclusion Criteria - No subjects will have:

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

Sites / Locations

Indiana University School of Dentistry Graduate Endodontics Dept.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Buffered 2% lidocaine with 1:100,000 epinephrine

Unbuffered 2% lidocaine with 1:100,000 epinephrine

Arm Description

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

Standard local anesthetic

Outcomes

Primary Outcome Measures

Profoundness of pulpal anesthesia

Number of Participants who demonstrate profound pulpal anesthesia, defined as an electrical pulp test score of 80 (maximum stimulation)

Secondary Outcome Measures

Onset of pulpal anesthesia

Duration of time required to achieve pulpal anesthesia, defined as an electrical pulp test score of 80 (maximum stimulation)

Full Information

NCT ID

NCT05227300

First Posted

January 7, 2022

Last Updated

March 28, 2022

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT05227300

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 14, 2022 (Actual)

Primary Completion Date

May 31, 2022 (Anticipated)

Study Completion Date

May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Symptomatic Irreversible Pulpitis

Keywords

lidocaine, buffered, local anesthetic, irreversible pulpitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Buffered 2% lidocaine with 1:100,000 epinephrine

Arm Type

Experimental

Arm Description

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

Arm Title

Unbuffered 2% lidocaine with 1:100,000 epinephrine

Arm Type

Active Comparator

Arm Description

Standard local anesthetic

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

2% lidocaine with 1:100,000 epinephrine

Intervention Description

Septodont's standard formulation of 2% lidocaine with epinephrine

Primary Outcome Measure Information:

Title

Profoundness of pulpal anesthesia

Description

Number of Participants who demonstrate profound pulpal anesthesia, defined as an electrical pulp test score of 80 (maximum stimulation)

Time Frame

Up to 20 minutes post-drug administration

Secondary Outcome Measure Information:

Title

Onset of pulpal anesthesia

Description

Duration of time required to achieve pulpal anesthesia, defined as an electrical pulp test score of 80 (maximum stimulation)

Time Frame

Up to 20 minutes post-drug administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria - In order to participate, subjects must: 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 Exclusion Criteria - No subjects will have: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kenneth Spolnik, DDS

Phone

317-274-7280

kspolnik@iu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Peter Alena, DMD

Phone

317-274-5311

palena@iu.edu

Facility Information:

Facility Name

Indiana University School of Dentistry Graduate Endodontics Dept.

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kenneth Spolnik, DDS

Phone

317-274-7280

kspolnik@iu.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17368327

Citation

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.

Results Reference

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PubMed Identifier

17062748

Citation

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.

Results Reference

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PubMed Identifier

2827545

Citation

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.

Results Reference

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PubMed Identifier

25841959

Citation

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.

Results Reference

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PubMed Identifier

27507627

Citation

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.

Results Reference

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PubMed Identifier

23880260

Citation

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.

Results Reference

background

PubMed Identifier

22414822

Citation

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.

Results Reference

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

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