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Trial Outcomes & Findings for Testing the Anesthetic Effectiveness of Buffered Articaine Injected Next to a Lower First Molar. (NCT NCT01862614)

NCT ID: NCT01862614

Last Updated: 2021-05-26

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

60 minutes per injection sequence.

Results posted on

2021-05-26

Participant Flow

80 subjects will be recruited in this crossover study. Each of the subjects will receive the injection regimens at 2 separate appointments spaced at least 2 weeks apart.

Participant milestones

Participant milestones
Measure
Articaine (First)
Subjects receiving 1.8cc articaine injection at first appointment.
Buffered Articaine (First)
Subjects receiving injection of 1.8cc buffered articaine at first appointment.
First Appointment.
STARTED
40
40
First Appointment.
COMPLETED
40
40
First Appointment.
NOT COMPLETED
0
0
2 Week Washout Period.
STARTED
40
40
2 Week Washout Period.
COMPLETED
40
40
2 Week Washout Period.
NOT COMPLETED
0
0
Second Appointment.
STARTED
40
40
Second Appointment.
COMPLETED
40
40
Second Appointment.
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testing the Anesthetic Effectiveness of Buffered Articaine Injected Next to a Lower First Molar.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Articaine
n=80 Participants
Subjects receiving articaine injection.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
80 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
25.3 years
STANDARD_DEVIATION 2.5 • n=5 Participants
Sex: Female, Male
Female
38 Participants
n=5 Participants
Sex: Female, Male
Male
42 Participants
n=5 Participants
Region of Enrollment
United States
80 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes per injection sequence.

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

Outcome measures
Measure
Articaine
n=80 Participants
Subjects receiving articaine injection.
Buffered Articaine
n=80 Participants
Subjects receiving an injection of 1.8cc buffered articaine.
Number of Participants Achieving Pulpal Anesthesia.
52 Participants
57 Participants

Adverse Events

Articaine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Buffered Articaine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Nusstein, Professor

The Ohio State University College of Dentistry

Phone: 614-292-3596

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place