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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buffered 1% lidocaine | Active Comparator | 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. |
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| Non-Buffered lidocaine | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Intraoral maxillary field block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time to Pulpal Response After Maxillary Molar Anesthesia | Subjects' maxillary molar teeth will be tested before anesthetic and every 30 minutes with cold and electronic pulp test for presence of anesthesia as reported by subjects yes or no. | Every 30 minutes up to 120 minutes Total |
| Mean Time to Pulpal Response After Maxillary Canine Anesthesia | Subjects' maxillary molar teeth will be tested before anesthetic and every 30 minutes with cold and electronic pulp test for presence of anesthesia as reported by subjects yes or no. | Every 30 minute up to 120 minutes total |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond P White, Jr., DDS, PhD | UNC Department Oral and Maxillofacial Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina School of Dentistry | Chapel Hill | North Carolina | 27599-7450 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Buffered 1% Lidocaine, Then Non-Buffered 2% Lidocaine | At each treatment visit, participants were injected orally for maxillary field block (Posterior alveolar, Anterior alveolar, Palatal nerves). |
| FG001 | Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine | At each treatment visit, participants were injected orally for maxillary field block (Posterior alveolar, Anterior alveolar, Palatal nerves). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Washout (1 Week) |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants who were randomized to receive either Buffered 1% Lidocaine or Non-Buffered 2% Lidocaine |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Time to Pulpal Response After Maxillary Molar Anesthesia | Subjects' maxillary molar teeth will be tested before anesthetic and every 30 minutes with cold and electronic pulp test for presence of anesthesia as reported by subjects yes or no. | Posted | Mean | Standard Deviation | minutes | Every 30 minutes up to 120 minutes Total |
|
Adverse events collected for 24 hours following each of the injections administered during both treatment interventions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raymond P. White Jr., DDS, PhD | University of North Carolina at Chapel Hill | 919-537-3944 | ray_white@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2016 | Oct 3, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
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| Age, Continuous | Median | Inter-Quartile Range | Years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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| Primary | Mean Time to Pulpal Response After Maxillary Canine Anesthesia | Subjects' maxillary molar teeth will be tested before anesthetic and every 30 minutes with cold and electronic pulp test for presence of anesthesia as reported by subjects yes or no. | Posted | Mean | Standard Deviation | minutes | Every 30 minute up to 120 minutes total |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Non-Buffered 2% 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. | 0 | 24 | 0 | 24 | 0 | 24 |
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| Aniline Compounds |
| D000588 | Amines |