Effect of Buffered Numbing Solution on Patients With Toothaches

The Ohio State University

Status: Completed

Conditions: Irreversible Pulpitis (Toothache)

Treatments: Drug: nonbuffered lidocaine; Drug: buffered lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01868776

buffered anesthetic toothache

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

buffered lidocaine

Experimental group

Description:

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

Treatment:

Drug: buffered lidocaine

nonbuffered lidocaine

Active Comparator group

Description:

4% lidocaine with 1:100,000 epinephrine

Treatment:

Drug: nonbuffered lidocaine