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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Local Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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lidocaine & sodium bicarbonate

2% lidocaine with 1: 80,000 epinephrine buffered with 0.18 mL of 8.4% sodium bicarbonate

Group Type EXPERIMENTAL

2% lidocaine with 1:80,000 epinephrine

Intervention Type DRUG

2% lidocaine with 1:80,000 epinephrine

sodium bicarbonate

Intervention Type DRUG

8.4% sodium bicarbonate

lidocaine & placebo

2% lidocaine with 1:80,000 epinephrine with 0.18 mL of sterile distilled water

Group Type ACTIVE_COMPARATOR

2% lidocaine with 1:80,000 epinephrine

Intervention Type DRUG

2% lidocaine with 1:80,000 epinephrine

placebo

Intervention Type DRUG

sterile distilled water (Samen Pharmaceutical Co, Iran)

Interventions

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2% lidocaine with 1:80,000 epinephrine

Intervention Type DRUG

sodium bicarbonate

8.4% sodium bicarbonate

Intervention Type DRUG

placebo

sterile distilled water (Samen Pharmaceutical Co, Iran)

Intervention Type DRUG

Other Intervention Names

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Lignospan; Septodont, Saint Maur des Fosses, France Samen Laboratories (Mashhad, Iran) sterile distilled water (Samen Pharmaceutical Co, Iran)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes