Clinical Outcomes Maxilla: Buffered 1% Lidocaine vs. Non-buffered 2% Lidocaine



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 30
Updated:12/21/2018
Start Date:May 2016
End Date:December 31, 2017

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Pilot Study: Comparison of Buffered 1% vs. Non-Buffered 2% Lidocaine Used in Dental and Oral Surgical Procedures: Clinical Outcomes Maxilla

Anecdotal data suggest that the buffered form of the local anesthetic is more potent at equal
dosages, and a lower dosage of the buffered drug might be used with an effect equal to higher
dosage not buffered. Clinical data are needed to confirm these anecdotal data. No published
data exist comparing buffered local anesthetics at lower drug concentrations to current
dosages commonly used in dental and oral surgical procedures

Specific Aims:

Compare clinical depths of pulpal anesthesia for maxillary molar and canine teeth at 30min
intervals post injection after maxillary field block anesthesia with buffered 1% lidocaine
with 1/100,000 epinephrine as compared to non-buffered 2% lidocaine with 1/100,000
epinephrine.

Hypotheses:

No differences exist in anesthetic depth for pulpal anesthesia after intraoral injection for
maxillary field block anesthesia between buffered 1% lidocaine with 1/100,000 epinephrine as
compared to non-buffered 2% lidocaine with 1/100,000 epinephrine.

Study Time Frame: 6 months: Month One Recruit 24 volunteers as subjects, Prepare case-books.
Months Two-Three Clinical Study. Months Four-Five Analyze Lab data. Month Six Prepare
Abstracts, Papers Methods: Blinded, Randomized Clinical Design, Recruit subjects with
Institutional Review Board approved consent at University of North Carolina. Subjects will
serve as their own controls in a cross-over AB/BA study design which is uniform within
sequences, uniform within periods, and balanced. Randomized subjects to be injected orally
for maxillary field block (Posterior alveolar, Anterior alveolar, Palatal sensory nerves)
alternatively with 4cc of buffered 1% lidocaine with 1/100,000 epinephrine and 4cc
non-buffered of 2% lidocaine with 1/100,000 epinephrine.

Assessment: pre, and post-anesthetic administration for pulpal anesthesia with cold,
electronic pulp test at maxillary molar and canine at 30 minute intervals.

Inclusion Criteria:

- American Society of Anesthesiologists Risk Classification I Willingness to participate
in two sessions

Exclusion Criteria:

- Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week
Current symptoms teeth or oral mucosa
We found this trial at
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Chapel Hill, North Carolina 27599
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