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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-14

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Symptomatic Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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Buffered 2% lidocaine with 1:100,000 epinephrine

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

2% lidocaine with 1:100,000 epinephrine

Intervention Type DRUG

Septodont's standard formulation of 2% lidocaine with epinephrine

Unbuffered 2% lidocaine with 1:100,000 epinephrine

Standard local anesthetic

Group Type ACTIVE_COMPARATOR

2% lidocaine with 1:100,000 epinephrine

Intervention Type DRUG

Septodont's standard formulation of 2% lidocaine with epinephrine

Interventions

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

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

Intervention Type DRUG

2% lidocaine with 1:100,000 epinephrine

Septodont's standard formulation of 2% lidocaine with epinephrine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes