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

Indiana University

Status and phase: Completed; Phase 4

Conditions: Symptomatic Irreversible Pulpitis

Treatments: Drug: 2% lidocaine with 1:100,000 epinephrine; Drug: Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05227300

11447

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Buffered 2% lidocaine with 1:100,000 epinephrine

Experimental group

Description:

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

Treatment:

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 group

Description:

Standard local anesthetic

Treatment:

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