Clinical Outcomes of Buffered vs. Non-Buffered Lidocaine

NCT02620683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2018-01-23

Study results available
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Summary

Anecdotal reports suggest buffering lidocaine with epinephrine just before intraoral injection reduces time of onset, results in a deeper anesthetic effect, without the "sting" with injection from a low pH. Additional data are needed to establish clinical important outcomes such as the peak blood level of lidocaine as compared to the non-buffered drug combination.

Clinical pilot studies are proposed as the start of a series of investigations to support or modify the use of the buffered anesthetic for intraoral procedures.

Conditions

  • Blood Levels of Buffered vs Non-buffered Lidocaine
  • Anesthetics, Local

Interventions

DRUG

Lidocaine

See above

Sponsors & Collaborators

  • Dental Foundation of North Carolina, Inc.

    collaborator OTHER
  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Raymond P White, Jr, DDS, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-08-31
Completion
2017-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02620683 on ClinicalTrials.gov