Effect of Buffered Numbing Solution on Patients With Toothaches

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to determine the effect of buffered lidocaine (a numbing solution) on the ability to numb patients with toothaches. Buffered anesthetic (numbing) solutions have shown promise in some medical and dental research. Patients presenting with toothaches will be given either a buffered numbing solution or a nonbuffered numbing solution. Neither the patient nor the operator will know which solution they will receive. Root canal treatment will be performed on the tooth and the ability of the buffered versus non-buffered numbing solutions will be compared.

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Detailed Description

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Conditions

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Irreversible Pulpitis (Toothache)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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buffered lidocaine

4% lidocaine with 1:100,000 epinephrine/0.18 mEq/mL sodium bicarbonate.

Group Type EXPERIMENTAL

buffered lidocaine

Intervention Type DRUG

nonbuffered lidocaine

4% lidocaine with 1:100,000 epinephrine

Group Type ACTIVE_COMPARATOR

nonbuffered lidocaine

Intervention Type DRUG

Interventions

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buffered lidocaine

Intervention Type DRUG

nonbuffered lidocaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with a diagnosis of irreversible pulpitis (toothache) in a mandibular posterior tooth (back/bottom tooth) with moderate to severe pain
* ages 18 -65 years of age
* in good health (ASA I or II)
* able to grant informed consent.

Exclusion Criteria

* allergy to lidocaine (numbing solution
* significant medical problem (ASA III or IV)
* have taken CNS depressants or analgesic medications within the last 24 hours
* pregnancy or lactating
* non-English speaking
* inability to give informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No