Trial Outcomes & Findings for Testing the Anesthetic Effectiveness of Three Different Dental Local Anesthetics Injected Next to a Lower First Molar (NCT NCT01567839)

Results Overview

Two consecutive 80/80 readings (no patient response) during 60 minutes of testing with an electric pulp tester.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

60 minutes

Results posted on

2014-01-01

Participant Flow

Recruitment at the College of Dentistry between May 2012 and December 2012.

No exclusions. All subjects enrolled were utilized and assigned.

Participant milestones

Participant milestones
Measure	Subjects Receiving Injections All subjects received each of the three anesthetic injections.
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testing the Anesthetic Effectiveness of Three Different Dental Local Anesthetics Injected Next to a Lower First Molar

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Receiving Injections n=60 Participants All subjects received each of the three anesthetic injections.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	25.8 years STANDARD_DEVIATION 2.5 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes

Two consecutive 80/80 readings (no patient response) during 60 minutes of testing with an electric pulp tester.

Outcome measures

Outcome measures
Measure	4% Articaine With 1:100,000 Epinephrine n=60 Participants	4% Lidocaine With 1:100,000 Epinephrine n=60 Participants	4% Prilocaine With 1:200,000 Epinephrine n=60 Participants
Successful Pulpal Anesthesia. Second Molar	37 participants	27 participants	22 participants
Successful Pulpal Anesthesia. First Molar	33 participants	20 participants	19 participants
Successful Pulpal Anesthesia. Second Premolar	32 participants	21 participants	17 participants
Successful Pulpal Anesthesia. First Premolar	29 participants	24 participants	18 participants

Adverse Events

4% Articaine With 1:100,000 Epinephrine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

4% Lidocaine With 1:100,000 Epinephrine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

4% Prilocaine With 1:200,000 Epinephrine

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

The Ohio State University, Division of Endodontics

Phone: 614-292-9412

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place