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



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 30
Updated:9/5/2018
Start Date:March 2016
End Date:September 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

Anecdotal data suggest that the buffered form of the local anesthetic is more potent at equal
dosages, and a lower dosage of the drug might be used with an effect equal to higher dosage
not buffered. Clinical data are needed to confirm these anecdotal data. No 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 (cold, Electronic Pulp Test) for mandibular
molar, and canine teeth at 30 minute intervals post injection for mandibular 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
mandibular 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 data Month Six: Prepare
Abstracts, Papers Methods: Blinded, Randomized Clinical Design Recruit subjects with
Institutional Review Board approved consent at UNC 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 mandibular block (inferior
alveolar, lingual, buccal 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: Mandibular molar, canine at 30 minute intervals Inclusion Criteria: Age
18-30 years, American Society Anesthesiologists (ASA) I Exclusion Criteria Allergy to
lidocaine class of anesthetic drugs, Local anesthetic drug past week Current symptoms teeth
or oral mucosa. SAS will be used for database management and statistical analysis.

Inclusion Criteria:

- Age 18-30 years, ASA I

Exclusion Criteria:

- Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week
Current symptoms teeth or oral mucosa
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Chapel Hill, North Carolina 27599
Phone: 919-537-3944
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