Combination of Buffered Anesthetic to Treat Mandibular Molars

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Sodium bicarbonate

Lidocaine w/ epi

Articaine w/ epi

Mepivacaine plain

About this trial

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

Eligibility Criteria

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

Inclusion Criteria: 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: 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

ndiana University School of Dentistry Graduate Endodontics Dept.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Buffered

Unbuffered

Arm Description

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)

Unbuffered 2% lidocaine with 1:100,000 epinephrine Unbuffered 4% articaine with 1:100,000 epinephrine Unbuffered 3% mepivacaine Standard local anesthetics

Outcomes

Primary Outcome Measures

Visual analogue scale (VAS) Scores as Measures of Profoundness of Pulpal Anesthesia

Patient will report their comfort during treatment based on a VAS graphic. Visual analog scale (VAS) is based on a scale of 1-10 related to patient comfort. A VAS score of 10 would mean the patient was extremely uncomfortable during treatment meaning there was inadequate anesthesia.

Secondary Outcome Measures

Onset of Pulpal Anesthesia

An electronic pulp tester will be used to assess anesthesia after anesthetic is administered

Full Information

NCT ID

NCT06047366

First Posted

September 14, 2023

Last Updated

October 11, 2023

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT06047366

Brief Title

Combination of Buffered Anesthetic to Treat Mandibular Molars

Official Title

Buffered vs Unbuffered Local Anesthesia Using Lidocaine, Carbocaine, and Articaine in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2023 (Anticipated)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (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

No

Product Manufactured in and Exported from the U.S.

No

5. Study Description

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.

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.

6. Conditions and Keywords

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

Symptomatic Irreversible Pulpitis

Keywords

lidocaine, articaine, mepivacaine, 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 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.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Buffered

Arm Type

Experimental

Arm Description

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)

Arm Title

Unbuffered

Arm Type

Active Comparator

Arm Description

Unbuffered 2% lidocaine with 1:100,000 epinephrine Unbuffered 4% articaine with 1:100,000 epinephrine Unbuffered 3% mepivacaine Standard local anesthetics

Intervention Type

Drug

Intervention Name(s)

Sodium bicarbonate

Other Intervention Name(s)

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

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)

Lidocaine w/ epi

Other Intervention Name(s)

2% lidocaine with 1:100,000 epinephrine

Intervention Description

Septodont's standard formulation of 2% lidocaine with epinephrine

Intervention Type

Drug

Intervention Name(s)

Articaine w/ epi

Other Intervention Name(s)

4% articaine with 1:100,000 epinephrine

Intervention Description

Septodont's standard formulation of 4% articaine with epinephrine

Intervention Type

Drug

Intervention Name(s)

Mepivacaine plain

Other Intervention Name(s)

3% Mepivacaine

Intervention Description

Septodont's standard formulation of 3% mepivacaine

Primary Outcome Measure Information:

Title

Visual analogue scale (VAS) Scores as Measures of Profoundness of Pulpal Anesthesia

Description

Patient will report their comfort during treatment based on a VAS graphic. Visual analog scale (VAS) is based on a scale of 1-10 related to patient comfort. A VAS score of 10 would mean the patient was extremely uncomfortable during treatment meaning there was inadequate anesthesia.

Time Frame

Up to 20 minutes post-drug administration

Secondary Outcome Measure Information:

Title

Onset of Pulpal Anesthesia

Description

An electronic pulp tester will be used to assess anesthesia after anesthetic is administered

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: 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: 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

Email

kspolnik@iu.edu

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

Steven Magura, DDS

Phone

2199297735

Email

sdmagura@iu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth Spolnik, DDS

Organizational Affiliation

Program Director

Official's Role

Study Chair

Facility Information:

Facility Name

ndiana University School of Dentistry Graduate Endodontics Dept.

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kenneth Spolnik, DDS

Phone

317-274-7280

Email

kspolnik@iu.edu

First Name & Middle Initial & Last Name & Degree

Steven Magura, DDS

Phone

2199297735

Email

sdmagura@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

No

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

background

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

background

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

background

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

background

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

background

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

background

Symptomatic Irreversible Pulpitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial