NCT06047366

Combination of Buffered Anesthetic to Treat Mandibular Molars

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Symptomatic Irreversible Pulpitis

Interventions

Type	Name	Description
DRUG	Sodium bicarbonate	Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic
DRUG	Lidocaine w/ epi	Septodont's standard formulation of 2% lidocaine with epinephrine
DRUG	Articaine w/ epi	Septodont's standard formulation of 4% articaine with epinephrine
DRUG	Mepivacaine plain	Septodont's standard formulation of 3% mepivacaine

Timeline

• Start date: 2023-12-05
• Primary completion: 2024-05-15
• Completion: 2024-05-15
• First posted: 2023-09-21
• Last updated: 2025-05-13
• Results posted: 2025-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study