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Clinical Outcomes Mandible: Buffered 1% vs. Non-Buffered 1% Lidocaine

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ClinicalTrials.gov Identifier: NCT03127943
Recruitment Status : Completed
First Posted : April 25, 2017
Results First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
Assess the clinical impact of Buffered 1% lidocaine with epinephrine as compared to the Non-buffered 1% lidocaine with epinephrine in dental and oral surgical procedures.

Condition or disease Intervention/treatment Phase
Anesthesia, Local Drug: Lidocaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Masking Description: double blind
Primary Purpose: Treatment
Official Title: Pilot Study: Comparison of Buffered 1% vs. Non-Buffered 1% Lidocaine Used in Dental and Oral Surgical Procedures: Clinical Outcomes Mandible
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Buffered 1% lidocaine

In week One, Each subject would be injected intraorally with either anesthetic (Buffered 1% lidocaine with 1/100,00 epinephrine) or (Non-buffered 1% lidocaine with 1/100,00 epinephrine to block the Inferior alveolar, Lingual and Buccal nerves.

At least a week later injections for the same nerves would involve the alternate anesthetic. Mandibular molar and canine tested for pulpal anesthesia.

Drug: Lidocaine
Efficacy for mandibular molar and canine anesthesia
Other Name: xylocaine

Active Comparator: Non-buffered 1% lidocaine

In week Two, Each subject would be injected intraorally with the alternate anesthetic (Buffered 1% lidocaine with 1/100,00 epinephrine) or (Non-buffered 1% lidocaine with 1/100,00 epinephrine to block the Inferior alveolar, Lingual and Buccal nerves.

At least a week later injections for the same nerves would involve the alternate anesthetic. Mandibular molar and canine tested for pulpal anesthesia.

Drug: Lidocaine
Efficacy for mandibular molar and canine anesthesia
Other Name: xylocaine




Primary Outcome Measures :
  1. Mean Time to Pulpal Response After Mandibular Molar Anesthesia [ Time Frame: Every 30 minutes up to 120 minutes Total ]
    Subjects' mandibular molar teeth will be tested before anesthetic and every 30 minutes with cold and electric pulp test for presence of anesthesia as reported by subjects yes or no

  2. Mean Time to Pulpal Response After Mandibular Canine Anesthesia [ Time Frame: 30 minute intervals up to 120 minutes ]
    Subjects' mandibular molar teeth will be tested before anesthetic and every 30 minutes with cold and electric pulp test for presence of anesthesia as reported by subjects yes or no



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Age 18-30 years American Society Anesthesiologists I,II

Exclusion Criteria:

Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week Current symptoms in teeth or oral mucosa


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127943


Locations
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United States, North Carolina
UNC School of Dentistry
Chapel Hill, North Carolina, United States, 27599-7450
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Study Chair: Timothy Turvey, DDS UNC Oral and Maxillofacial Surgery
Principal Investigator: Raymond P White Jr, DDS, PhD University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03127943    
Other Study ID Numbers: 16-0068
First Posted: April 25, 2017    Key Record Dates
Results First Posted: February 6, 2019
Last Update Posted: February 6, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of North Carolina, Chapel Hill:
lidocaine, mandible
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action