Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of IAN Block of Teeth With Irreversible Pulpitis

Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of Inferior Alveolar Nerve Block for Teeth With Symptomatic Irreversible Pulpitis: A Prospective, Randomized Double-blind Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02226913

Enrollment

Registered

2014-08-27

Start date

2013-02-28

Completion date

2013-09-30

Last updated

2016-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Anesthesia

Keywords

Buffered, inferior alveolar nerve block, irreversible pulpitis, local anesthesia, sodium bicarbonate

Brief summary

Buffering of local anesthetics (alkalinization) has been suggested in achieving pain control. The purpose of this prospective, randomized, double-blind study was to evaluate the effect of adding 0.6 mL 8.4% sodium bicarbonate to 3.0 mL 2% lidocaine with 1: 80,000 epinephrine on the success rate of IAN block for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.

Detailed description

Some studies have been shown buffering of local anesthetics reduce pain of injection, hasten the onset of anesthesia, and improved success rate of anesthesia. Others reported buffering of local anesthetics cannot reduce pain of injection, hasten the onset of anesthesia, and improve success rate of anesthesia. There are no studies evaluating a sodium bicarbonate-buffered lidocaine formulation for IAN block for teeth with irreversible pulpitis.

Interventions

DRUG2% lidocaine with 1:80,000 epinephrine

2% lidocaine with 1:80,000 epinephrine

DRUGsodium bicarbonate

8.4% sodium bicarbonate

DRUGplacebo

sterile distilled water (Samen Pharmaceutical Co, Iran)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* vital mandibular molar tooth * diagnosis of symptomatic irreversible pulpitis

Exclusion criteria

* younger than 18 years old * history of significant medical conditions * allergies to local anesthetics or sulfites * pregnancy * taking any medications that might influence anesthetic assessment * active sites of pathosis in area of injection * inability to give informed consent

Design outcomes

Primary

Measure	Time frame
Percentage of the success of IAN Block anesthesia with a buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block	Baseline

Secondary

Measure	Time frame
Heft-Parker visual analog scale recording of a non-buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block	Baseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026