Trial Outcomes & Findings for Buffered vs. Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis (NCT NCT05227300)
NCT ID: NCT05227300
Last Updated: 2024-05-14
Results Overview
The mean Visual Analog Scale (VAS) score, which ranges from a min of 1 to a max of 10. In other words, inadequate anesthesia is considered to be a VAS score that is between 4 and 10 because that is not considered to be "comfortable and profound".
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Up to 20 minutes post-drug administration
Results posted on
2024-05-14
Participant Flow
Participant milestones
| Measure |
Buffered 2% Lidocaine With 1:100,000 Epinephrine
Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution)
Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution: Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic
2% lidocaine with 1:100,000 epinephrine: Septodont's standard formulation of 2% lidocaine with epinephrine
|
Unbuffered 2% Lidocaine With 1:100,000 Epinephrine
Standard local anesthetic
2% lidocaine with 1:100,000 epinephrine: Septodont's standard formulation of 2% lidocaine with epinephrine
|
|---|---|---|
|
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
| Measure |
Buffered 2% Lidocaine With 1:100,000 Epinephrine
n=20 Participants
Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution)
Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution: Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic
2% lidocaine with 1:100,000 epinephrine: Septodont's standard formulation of 2% lidocaine with epinephrine
|
Unbuffered 2% Lidocaine With 1:100,000 Epinephrine
n=20 Participants
Standard local anesthetic
2% lidocaine with 1:100,000 epinephrine: Septodont's standard formulation of 2% lidocaine with epinephrine
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.2 Years
STANDARD_DEVIATION 13.5 • n=20 Participants
|
38 Years
STANDARD_DEVIATION 19.4 • n=20 Participants
|
39.6 Years
STANDARD_DEVIATION 16.6 • n=40 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
17 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
|
|
Initial Visual Analog Scale (VAS) w/ a min score of 1 and max score of 10 (a 4+ is significant pain)
|
7.8 Units on a Scale
n=20 Participants
|
6.9 Units on a Scale
n=20 Participants
|
7.35 Units on a Scale
n=40 Participants
|
|
Initial Electronic Pulp Test (EPT) less than 80 shows vital pulp (min stimulation is 1, max is 80)
|
42.9 Units on a scale
n=20 Participants
|
47.3 Units on a scale
n=20 Participants
|
45.1 Units on a scale
n=40 Participants
|
PRIMARY outcome
Timeframe: Up to 20 minutes post-drug administrationThe mean Visual Analog Scale (VAS) score, which ranges from a min of 1 to a max of 10. In other words, inadequate anesthesia is considered to be a VAS score that is between 4 and 10 because that is not considered to be "comfortable and profound".
Outcome measures
| Measure |
Buffered 2% Lidocaine With 1:100,000 Epinephrine
n=20 Participants
Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution)
Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution: Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic
2% lidocaine with 1:100,000 epinephrine: Septodont's standard formulation of 2% lidocaine with epinephrine
|
Unbuffered 2% Lidocaine With 1:100,000 Epinephrine
n=20 Participants
Standard local anesthetic
2% lidocaine with 1:100,000 epinephrine: Septodont's standard formulation of 2% lidocaine with epinephrine
|
|---|---|---|
|
VAS Scores as Measures of Profoundness of Pulpal Anesthesia
|
3.1 Score on a scale
Interval 0.0 to 8.0
|
1.2 Score on a scale
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: Up to 20 minutes post-drug administrationDuration of time in minutes required to achieve pulpal anesthesia, defined as an electrical pulp test score of 80 (which is the maximum stimulation). Any EPT score between 1-79 after 20 minutes post-anesthesia is considered a failure of pulpal anesthesia.
Outcome measures
| Measure |
Buffered 2% Lidocaine With 1:100,000 Epinephrine
n=20 Participants
Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution)
Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution: Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic
2% lidocaine with 1:100,000 epinephrine: Septodont's standard formulation of 2% lidocaine with epinephrine
|
Unbuffered 2% Lidocaine With 1:100,000 Epinephrine
n=20 Participants
Standard local anesthetic
2% lidocaine with 1:100,000 epinephrine: Septodont's standard formulation of 2% lidocaine with epinephrine
|
|---|---|---|
|
Onset of Pulpal Anesthesia
|
8.4 Minutes
Interval 3.8 to 14.0
|
8.8 Minutes
Interval 3.2 to 17.2
|
Adverse Events
Buffered 2% Lidocaine With 1:100,000 Epinephrine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unbuffered 2% Lidocaine With 1:100,000 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. Kenneth 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