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N/A N=100 Randomized Double-blind Treatment

Effect of Buffered Numbing Solution on Patients With Toothaches

Irreversible Pulpitis (Toothache)

Enrolled (actual)
100
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Percent of Patients With Successful Anesthesia (% of Patients Able to Have Treatment Without Additional Anesthesia) — 16; 20 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
buffered lidocaine (Drug); nonbuffered lidocaine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Ohio State University
Primary completion
Dec 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent of Patients With Successful Anesthesia (% of Patients Able to Have Treatment Without Additional Anesthesia)
16; 20
PRIMARY
Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis.
32; 40

Summary

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01868776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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