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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buffered 1% lidocaine | Active Comparator | 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 |
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| Non-Buffered lidocaine | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Lidocaine |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Time to Pulpal Response After Mandibular Molar Anesthesia | Subject's Mandibular first molar teeth tested before anesthetic and every 30 minutes after for response to Cold and Electric Pulp Test as reported by subjects as a "yes" or "no." | Every 30 minutes up to 120 minutes total |
| Mean Time to Pulpal Response After Mandibular Canine Anesthesia | Subject's Mandibular canine teeth will be tested before anesthetic and every 30 minutes after for response to Cold and Electronic Pulp Test for presence of anesthesia as reported by participants "yes" or "no." | Every 30 minutes 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 Dept Oral and Maxillofacial Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC 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 mandibular block (inferior alveolar, lingual, buccal nerves). For this arm, participants first received Buffered 1% Lidocaine followed by a 1-week washout, then Non-buffered 2% Lidocaine. |
| FG001 | Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine | At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves). For this arm, participants first received Non-Buffered 2% Lidocaine followed by a 1-week washout, then Buffered 1% Lidocaine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (Visit 1) |
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| Washout (at Least 1 Week) |
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| Second Intervention (Visit 2) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who were randomized to received 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 Mandibular Molar Anesthesia | Subject's Mandibular first molar teeth tested before anesthetic and every 30 minutes after for response to Cold and Electric Pulp Test as reported by subjects as a "yes" or "no." | Posted | Mean | Standard Deviation | Minutes | Every 30 minutes up to 120 minutes total |
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Adverse events collected for 24 hours after active component of the trial
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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 | At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves). For this arm, participants first received Buffered 1% Lidocaine followed by a 1-week washout, then Non-buffered 2% Lidocaine. |
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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 | Jan 1, 2016 | Jul 26, 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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| Sex: Female, Male | Count of Participants | Participants |
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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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At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).
For this arm, participants first received Non-Buffered 2% Lidocaine followed by a 1-week washout, then Buffered 1% Lidocaine.
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| Primary | Mean Time to Pulpal Response After Mandibular Canine Anesthesia | Subject's Mandibular canine teeth will be tested before anesthetic and every 30 minutes after for response to Cold and Electronic Pulp Test for presence of anesthesia as reported by participants "yes" or "no." | Posted | Mean | Standard Deviation | Minutes | Every 30 minutes up to 120 minutes total |
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| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Non-Buffered 2% Lidocaine | At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves). For this arm, participants first received Non-Buffered 2% Lidocaine followed by a 1-week washout, then Buffered 1% Lidocaine. | 0 | 23 | 0 | 23 | 0 | 23 |
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| Aniline Compounds |
| D000588 | Amines |