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

NCT ID: NCT02747186

Last Updated: 2018-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Anesthesia

Keywords

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lidocaine, jaw

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Buffered 1% lidocaine

In week One each subject would receive the anesthetic, 5cc, to block the Posterior alveolar, Anterior alveolar, Palatal nerves.Maxillary molar and canine tested for pulpal anesthesia.

At least a week later, injections for the maxillary field block would involve the alternate local anesthetic combination. Maxillary molar and canine tested for pulpal anesthesia.

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Intraoral maxillary field block

Non-Buffered lidocaine

In week One each subject would receive the anesthetic, 5cc, to block the Posterior alveolar, Anterior alveolar, Palatal nerves. Maxillary molar and canine tested for pulpal anesthesia.

At least a week later, injections for the maxillary field block would involve the alternate local anesthetic combination. Maxillary molar and canine tested for pulpal anesthesia.

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Intraoral maxillary field block

Interventions

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Lidocaine

Intraoral maxillary field block

Intervention Type DRUG

Other Intervention Names

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xylocaine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raymond P White, Jr., DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Department Oral and Maxillofacial Surgery

Locations

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University of North Carolina School of Dentistry

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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16-0068b

Identifier Type: -

Identifier Source: org_study_id