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Effect of Buffered Numbing Solution on Patients With Toothaches

The Ohio State University logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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