Trial Outcomes & Findings for Clinical Outcomes Mandible: Buffered 1% vs. Non-Buffered 1% Lidocaine (NCT NCT03127943)
NCT ID: NCT03127943
Last Updated: 2019-02-06
Results Overview
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
COMPLETED
PHASE4
24 participants
Every 30 minutes up to 120 minutes Total
2019-02-06
Participant Flow
Participant milestones
| Measure |
Buffered 1% Lidocaine, Then Non-Buffered 1% Lidocaine
At each treatment visit participants were injected to block the Inferior alveolar, Lingual and Buccal nerves.
|
Non-Buffered 1% Lidocaine, Then Buffered 1% Lidocaine
At each treatment visit participants were injected to block the Inferior alveolar, Lingual and Buccal 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 Mandible: Buffered 1% vs. Non-Buffered 1% Lidocaine
Baseline characteristics by cohort
| Measure |
All Study Participants
n=24 Participants
Participants who were 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
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 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' 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
Outcome measures
| Measure |
Buffered 1% Lidocaine, Then Non-Buffered 1% Lidocaine
n=24 Participants
All subjects who received Buffered 1% Lidocaine
|
Non-buffered 1% Lididocaine, the Buffered 1% Lidocaine
n=24 Participants
All subjects who received Non\_buffered Lidocaine
|
|---|---|---|
|
Mean Time to Pulpal Response After Mandibular Molar Anesthesia
|
100 minutes
Standard Deviation 37.2
|
106 minutes
Standard Deviation 41.5
|
PRIMARY outcome
Timeframe: 30 minute intervals up to 120 minutesSubjects' 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
Outcome measures
| Measure |
Buffered 1% Lidocaine, Then Non-Buffered 1% Lidocaine
n=24 Participants
All subjects who received Buffered 1% Lidocaine
|
Non-buffered 1% Lididocaine, the Buffered 1% Lidocaine
n=24 Participants
All subjects who received Non\_buffered Lidocaine
|
|---|---|---|
|
Mean Time to Pulpal Response After Mandibular Canine Anesthesia
|
81.3 minutes
Standard Deviation 44.7
|
97.5 minutes
Standard Deviation 43.6
|
Adverse Events
Buffered 1% Lidocaine
Non-Buffered 1% 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
UNC Department of Oral and Maxillofacial Surgery
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place