Trial Outcomes & Findings for The Anesthetic Efficacy of 3% Mepivacaine Plus 2% Lidocaine With 1:100,000 Epinephrine for Lower Jaw Dental Injections (NCT NCT01574807)
NCT ID: NCT01574807
Last Updated: 2020-11-17
Results Overview
An electric pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success.
COMPLETED
PHASE4
100 participants
60 minutes per injection sequence.
2020-11-17
Participant Flow
Recruitment occurred from august 2011 to May 2013 in the dental clinic of the College of Dentistry.
No subjects were excluded from the study.
Participant milestones
| Measure |
Mepi/Lido + Lido/Lido Group
This group received Mepivacaine + lidocaine at 1st appointment and lidocaine + lidocaine at 2nd appointment.
|
Lido/Lido + Mepi/Lido Group
This group received injections of lidocaine + lidocaine at 1st appointment and Mepivacaine + lidocaine at second appointment.
|
|---|---|---|
|
First Appointment
STARTED
|
50
|
50
|
|
First Appointment
COMPLETED
|
50
|
50
|
|
First Appointment
NOT COMPLETED
|
0
|
0
|
|
Wash Out Period 2 Weeks
STARTED
|
50
|
50
|
|
Wash Out Period 2 Weeks
COMPLETED
|
50
|
50
|
|
Wash Out Period 2 Weeks
NOT COMPLETED
|
0
|
0
|
|
Second Appointment
STARTED
|
50
|
50
|
|
Second Appointment
COMPLETED
|
50
|
50
|
|
Second Appointment
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Anesthetic Efficacy of 3% Mepivacaine Plus 2% Lidocaine With 1:100,000 Epinephrine for Lower Jaw Dental Injections
Baseline characteristics by cohort
| Measure |
All Participants
n=100 Participants
All participants receive 3% mepivacaine + 2% lidocaine versus 2% lidocaine + 2% lidocaine injections in different randomized sequences.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 60 minutes per injection sequence.Population: Success of anesthesia was determined by subject achieving maximal level (80) with testing device by 5th testing time period (17 min.) following injection and maintaining that maximal response for the remainder of the testing time.
An electric pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success.
Outcome measures
| Measure |
Mepivacaine + Lidocaine
n=100 Participants
Clinical appointment where: 1.8cc 3% mepivacine + 1.8cc 2% lidocaine is injected.
|
Lidocaine + Lidocaine
n=100 Participants
Clinical appointment where - 1.8cc 2% lidocaine + 1.8cc 2% lidocaine is injected.
|
|---|---|---|
|
Number of Participants Achieving Pulpal Anesthesia Success.
|
44 Participants
|
40 Participants
|
Adverse Events
Treatment Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place