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

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Anesthesia

Treatments

Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02708433
16-0068a

Details and patient eligibility

About

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

Full description

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.

Enrollment

23 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

23 participants in 2 patient groups

Buffered 1% lidocaine
Active Comparator group
Description:
In week one each subject would receive either anesthetic (Buffered 1% lidocaine with 1/100,000 Epinephrine) or (Non-Buffered 2% lidocaine with 1/100,000 Epinephrine) to block the inferior alveolar, lingual, buccal nerves. In week two the alternate anesthetic would be administered. Mandibular molar and canine tested for pulpal anesthesia
Treatment:
Drug: Lidocaine
Non-Buffered lidocaine
Active Comparator group
Description:
In week two each subject would receive the alternate anesthetic (Buffered 1% lidocaine with 1/100,000 Epinephrine) or (Non-Buffered 2% lidocaine with 1/100,000 Epinephrine) to block the inferior alveolar, lingual, buccal nerves. Mandibular molar and canine tested for pulpal anesthesia
Treatment:
Drug: Lidocaine

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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