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

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ClinicalTrials.gov Identifier: NCT02708433
Recruitment Status : Completed
First Posted : March 15, 2016
Results First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Anesthesia
Intervention Drug: Lidocaine
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Buffered 1% Lidocaine, Then Non-buffered 2% Lidocaine Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine
Hide Arm/Group Description

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.

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.

Period Title: First Intervention (Visit 1)
Started 12 11
Completed 12 11
Not Completed 0 0
Period Title: Washout (at Least 1 Week)
Started 12 11
Completed 12 11
Not Completed 0 0
Period Title: Second Intervention (Visit 2)
Started 12 11
Completed 12 11
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description All participants who were randomized to received either Buffered 1% Lidocaine or Non-buffered 2% Lidocaine
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
<=18 years
0
   0.0%
Between 18 and 65 years
23
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
13
  56.5%
Male
10
  43.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Hispanic or Latino
1
   4.3%
Not Hispanic or Latino
22
  95.7%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
 100.0%
1.Primary Outcome
Title Mean Time to Pulpal Response After Mandibular Molar Anesthesia
Hide Description 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."
Time Frame Every 30 minutes up to 120 minutes total
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buffered 1% Lidocaine, Then Non-buffered 2% Lidocaine Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: Minutes
99  (49) 98  (45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Buffered 1% Lidocaine, Then Non-buffered 2% Lidocaine, Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Confidence Interval (2-Sided) 95%
-0.49 to 0.57
Parameter Dispersion
Type: Standard Deviation
Value: 49
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mean Time to Pulpal Response After Mandibular Canine Anesthesia
Hide Description 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."
Time Frame Every 30 minutes up to 120 minutes total
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buffered 1% Lidocaine, Then Non-buffered 2% Lidocaine Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: Minutes
82  (48) 85  (48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Buffered 1% Lidocaine, Then Non-buffered 2% Lidocaine, Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Confidence Interval (2-Sided) 95%
-0.89 to 0.52
Parameter Dispersion
Type: Standard Deviation
Value: 48
Estimation Comments [Not Specified]
Time Frame Adverse events collected for 24 hours after active component of the trial
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Buffered 1% Lidocaine Non-Buffered 2% Lidocaine
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Buffered 1% Lidocaine Non-Buffered 2% Lidocaine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Buffered 1% Lidocaine Non-Buffered 2% Lidocaine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Buffered 1% Lidocaine Non-Buffered 2% Lidocaine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Raymond P. White, Jr. DDS, PhD
Organization: University of North Carolina at Chapel Hill
Phone: 919-537-3944
EMail: ray_white@unc.edu
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02708433     History of Changes
Other Study ID Numbers: 16-0068a
First Submitted: March 3, 2016
First Posted: March 15, 2016
Results First Submitted: July 27, 2018
Results First Posted: September 3, 2018
Last Update Posted: September 3, 2018