Combination of Buffered Anesthetic to Treat Mandibular Molars

Indiana University

Status and phase: Terminated; Phase 4

Conditions: Symptomatic Irreversible Pulpitis

Treatments: Drug: Lidocaine w/ epi; Drug: Mepivacaine plain; Drug: Sodium bicarbonate; Drug: Articaine w/ epi

Study type: Interventional

Funder types: Other

Identifiers

NCT06047366

17799

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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

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

Experimental group

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)

Treatment:

Drug: Articaine w/ epi

Drug: Mepivacaine plain

Drug: Sodium bicarbonate

Drug: Lidocaine w/ epi

Unbuffered

Active Comparator group

Description:

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

Treatment:

Drug: Articaine w/ epi

Drug: Mepivacaine plain

Drug: Lidocaine w/ epi