NCT03127943

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 6, 2019

Completed
Last Updated

February 6, 2019

Status Verified

April 1, 2018

Enrollment Period

11 months

First QC Date

April 20, 2017

Results QC Date

January 14, 2019

Last Update Submit

January 14, 2019

Conditions

Anesthesia, Local

Keywords

lidocaine, mandible

Outcome Measures

Primary Outcomes (2)

  • Mean Time to Pulpal Response After Mandibular Molar Anesthesia

    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

    Every 30 minutes up to 120 minutes Total

  • Mean Time to Pulpal Response After Mandibular Canine Anesthesia

    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

    30 minute intervals up to 120 minutes

Study Arms (2)

Buffered 1% lidocaine

ACTIVE COMPARATOR

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

Non-buffered 1% lidocaine

ACTIVE COMPARATOR

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

Interventions

LidocaineDRUG

Efficacy for mandibular molar and canine anesthesia

Also known as: xylocaine
Buffered 1% lidocaineNon-buffered 1% lidocaine

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-30 years American Society Anesthesiologists I,II

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC School of Dentistry

Chapel Hill, North Carolina, 27599-7450, United States

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Raymond P. White Jr DDS, PhD
Organization
UNC Department of Oral and Maxillofacial Surgery
ray_white@unc.edu
919-537-3944

Study Officials

  • Timothy Turvey, DDS

    UNC Oral and Maxillofacial Surgery

    STUDY CHAIR

  • Raymond P White Jr, DDS, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
double blind
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2017

First Posted

April 25, 2017

Study Start

May 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

February 6, 2019

Results First Posted

February 6, 2019

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)