NCT05227300

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

Buffered vs. Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis: A Controlled, Randomized Double-blind Study

• Status: Completed
• 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 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.

Detailed 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.

Conditions

• Symptomatic Irreversible Pulpitis

Interventions

Type	Name	Description
DRUG	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
DRUG	2% lidocaine with 1:100,000 epinephrine	Septodont's standard formulation of 2% lidocaine with epinephrine

Timeline

• Start date: 2022-02-14
• Primary completion: 2022-05-23
• Completion: 2022-06-30
• First posted: 2022-02-07
• Last updated: 2024-05-14
• Results posted: 2024-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study