Combination of Buffered Anesthetic to Treat Mandibular Molars

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-05

Study Completion Date

2024-05-15

Brief Summary

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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.

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Detailed Description

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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.

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 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.

Study Groups

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Buffered

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)

Group Type EXPERIMENTAL

Sodium bicarbonate

Intervention Type DRUG

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

Lidocaine w/ epi

Intervention Type DRUG

Septodont's standard formulation of 2% lidocaine with epinephrine

Articaine w/ epi

Intervention Type DRUG

Septodont's standard formulation of 4% articaine with epinephrine

Mepivacaine plain

Intervention Type DRUG

Septodont's standard formulation of 3% mepivacaine

Unbuffered

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

Group Type ACTIVE_COMPARATOR

Lidocaine w/ epi

Intervention Type DRUG

Septodont's standard formulation of 2% lidocaine with epinephrine

Articaine w/ epi

Intervention Type DRUG

Septodont's standard formulation of 4% articaine with epinephrine

Mepivacaine plain

Intervention Type DRUG

Septodont's standard formulation of 3% mepivacaine

Interventions

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Sodium bicarbonate

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

Intervention Type DRUG

Lidocaine w/ epi

Septodont's standard formulation of 2% lidocaine with epinephrine

Intervention Type DRUG

Articaine w/ epi

Septodont's standard formulation of 4% articaine with epinephrine

Intervention Type DRUG

Mepivacaine plain

Septodont's standard formulation of 3% mepivacaine

Intervention Type DRUG

Other Intervention Names

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Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solutio 2% lidocaine with 1:100,000 epinephrine 4% articaine with 1:100,000 epinephrine 3% Mepivacaine

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