Trial Outcomes & Findings for Clinical Outcomes Maxilla: Buffered 1% Lidocaine vs. Non-buffered 2% Lidocaine (NCT NCT02747186)
NCT ID: NCT02747186
Last Updated: 2018-12-19
Results Overview
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.
COMPLETED
NA
24 participants
Every 30 minutes up to 120 minutes Total
2018-12-19
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
First Intervention
STARTED
|
12
|
12
|
|
First Intervention
COMPLETED
|
12
|
12
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
12
|
12
|
|
Washout (1 Week)
COMPLETED
|
12
|
12
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
12
|
12
|
|
Second Intervention
COMPLETED
|
12
|
12
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Outcomes Maxilla: Buffered 1% Lidocaine vs. Non-buffered 2% Lidocaine
Baseline characteristics by cohort
| Measure |
All Study Participants
n=24 Participants
Participants who were randomized to receive either Buffered 1% Lidocaine or Non-Buffered 2% Lidocaine
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
24 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 30 minutes up to 120 minutes TotalSubjects' 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.
Outcome measures
| Measure |
Buffered 1% Lidocaine
n=24 Participants
All subjects who received Buffered 1% Lidocaine.
|
Non-Buffered 2% Lidocaine
n=24 Participants
All subjects who received Non-Buffered 2% Lidocaine.
|
|---|---|---|
|
Mean Time to Pulpal Response After Maxillary Molar Anesthesia
|
98.8 minutes
Standard Deviation 30.6
|
84.5 minutes
Standard Deviation 27
|
PRIMARY outcome
Timeframe: Every 30 minute up to 120 minutes totalSubjects' 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.
Outcome measures
| Measure |
Buffered 1% Lidocaine
n=24 Participants
All subjects who received Buffered 1% Lidocaine.
|
Non-Buffered 2% Lidocaine
n=24 Participants
All subjects who received Non-Buffered 2% Lidocaine.
|
|---|---|---|
|
Mean Time to Pulpal Response After Maxillary Canine Anesthesia
|
77.1 minutes
Standard Deviation 30.8
|
70.9 minutes
Standard Deviation 35.3
|
Adverse Events
Buffered 1% Lidocaine
Non-Buffered 2% Lidocaine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Raymond P. White Jr., DDS, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place