Trial Outcomes & Findings for Combination of Buffered Anesthetic to Treat Mandibular Molars (NCT NCT06047366)

Last Updated: 2025-05-13

Results Overview

Patient will report their comfort during treatment based on a visual analogue scale (VAS) graphic. Visual analog scale (VAS) is based on a scale of 0-10 related to patient comfort. A VAS score of 10 would mean the patient was extremely uncomfortable during treatment indicating there was inadequate anesthesia. A VAS score of 0 indicates no pain.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

Up to 20 minutes post-drug administration

Results posted on

2025-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Buffered Buffered 2% lidocaine with 1:100,000 epinephrine Buffered 4% articaine with 1:100,000 epinephrine Buffered 3% mepivacaine Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution) Sodium bicarbonate: Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic Lidocaine w/ epi: Septodont's standard formulation of 2% lidocaine with epinephrine Articaine w/ epi: Septodont's standard formulation of 4% articaine with epinephrine Mepivacaine plain: Septodont's standard formulation of 3% mepivacaine	Unbuffered Unbuffered 2% lidocaine with 1:100,000 epinephrine Unbuffered 4% articaine with 1:100,000 epinephrine Unbuffered 3% mepivacaine Standard local anesthetics Lidocaine w/ epi: Septodont's standard formulation of 2% lidocaine with epinephrine Articaine w/ epi: Septodont's standard formulation of 4% articaine with epinephrine Mepivacaine plain: Septodont's standard formulation of 3% mepivacaine
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Buffered n=20 Participants Buffered 2% lidocaine with 1:100,000 epinephrine Buffered 4% articaine with 1:100,000 epinephrine Buffered 3% mepivacaine Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution) Sodium bicarbonate: Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic Lidocaine w/ epi: Septodont's standard formulation of 2% lidocaine with epinephrine Articaine w/ epi: Septodont's standard formulation of 4% articaine with epinephrine Mepivacaine plain: Septodont's standard formulation of 3% mepivacaine	Unbuffered n=20 Participants Unbuffered 2% lidocaine with 1:100,000 epinephrine Unbuffered 4% articaine with 1:100,000 epinephrine Unbuffered 3% mepivacaine Standard local anesthetics Lidocaine w/ epi: Septodont's standard formulation of 2% lidocaine with epinephrine Articaine w/ epi: Septodont's standard formulation of 4% articaine with epinephrine Mepivacaine plain: Septodont's standard formulation of 3% mepivacaine	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=20 Participants	20 Participants n=20 Participants	40 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Continuous	39 years n=20 Participants	28 years n=20 Participants	33.5 years n=40 Participants
Sex: Female, Male Female	12 Participants n=20 Participants	13 Participants n=20 Participants	25 Participants n=40 Participants
Sex: Female, Male Male	8 Participants n=20 Participants	7 Participants n=20 Participants	15 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	20 participants n=20 Participants	20 participants n=20 Participants	40 participants n=40 Participants

PRIMARY outcome

Timeframe: Up to 20 minutes post-drug administration

Population: Patients who achieved profound pulpal anesthesia

Outcome measures

Outcome measures
Measure	Buffered n=17 Participants Buffered 2% lidocaine with 1:100,000 epinephrine Buffered 4% articaine with 1:100,000 epinephrine Buffered 3% mepivacaine Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution) Sodium bicarbonate: Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic Lidocaine w/ epi: Septodont's standard formulation of 2% lidocaine with epinephrine Articaine w/ epi: Septodont's standard formulation of 4% articaine with epinephrine Mepivacaine plain: Septodont's standard formulation of 3% mepivacaine	Unbuffered n=15 Participants Unbuffered 2% lidocaine with 1:100,000 epinephrine Unbuffered 4% articaine with 1:100,000 epinephrine Unbuffered 3% mepivacaine Standard local anesthetics Lidocaine w/ epi: Septodont's standard formulation of 2% lidocaine with epinephrine Articaine w/ epi: Septodont's standard formulation of 4% articaine with epinephrine Mepivacaine plain: Septodont's standard formulation of 3% mepivacaine
Median Visual Analogue Scale (VAS) Score as a Measure of Profoundness of Pulpal Anesthesia	0 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Up to 15 minutes post-drug administration

An electronic pulp tester will be used to assess anesthesia after anesthetic is administered. The median time needed to achieve profound pulpal anesthesia for the two groups will be calculated using the Kaplan-Meier method and compared with a log-rank test, with patients who failed to achieve profound pulpal anesthesia censored at 15 minutes.

Outcome measures

Outcome measures
Measure	Buffered n=20 Participants Buffered 2% lidocaine with 1:100,000 epinephrine Buffered 4% articaine with 1:100,000 epinephrine Buffered 3% mepivacaine Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution) Sodium bicarbonate: Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic Lidocaine w/ epi: Septodont's standard formulation of 2% lidocaine with epinephrine Articaine w/ epi: Septodont's standard formulation of 4% articaine with epinephrine Mepivacaine plain: Septodont's standard formulation of 3% mepivacaine	Unbuffered n=20 Participants Unbuffered 2% lidocaine with 1:100,000 epinephrine Unbuffered 4% articaine with 1:100,000 epinephrine Unbuffered 3% mepivacaine Standard local anesthetics Lidocaine w/ epi: Septodont's standard formulation of 2% lidocaine with epinephrine Articaine w/ epi: Septodont's standard formulation of 4% articaine with epinephrine Mepivacaine plain: Septodont's standard formulation of 3% mepivacaine
Median Time to Profound Pulpal Anesthesia	5.28 minutes Interval 4.22 to 6.17	7.96 minutes Interval 5.5 to 10.15

Adverse Events

Buffered

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unbuffered

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. Ken Spolnik

Indiana University School of Dentistry

Phone: 317-274-7280

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place