Trial Outcomes & Findings for Clinical Outcomes of Buffered 1% Lidocaine vs. Non-buffered 2% Lidocaine (NCT NCT02708433)
NCT ID: NCT02708433
Last Updated: 2018-09-04
Results Overview
Subject's Mandibular first molar teeth tested before anesthetic and every 30 minutes after for response to Cold and Electric Pulp Test as reported by subjects as a "yes" or "no."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Every 30 minutes up to 120 minutes total
Results posted on
2018-09-04
Participant Flow
Participant milestones
| Measure |
Buffered 1% Lidocaine, Then Non-buffered 2% Lidocaine
At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).
For this arm, participants first received Buffered 1% Lidocaine followed by a 1-week washout, then Non-buffered 2% Lidocaine.
|
Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine
At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).
For this arm, participants first received Non-Buffered 2% Lidocaine followed by a 1-week washout, then Buffered 1% Lidocaine.
|
|---|---|---|
|
First Intervention (Visit 1)
STARTED
|
12
|
11
|
|
First Intervention (Visit 1)
COMPLETED
|
12
|
11
|
|
First Intervention (Visit 1)
NOT COMPLETED
|
0
|
0
|
|
Washout (at Least 1 Week)
STARTED
|
12
|
11
|
|
Washout (at Least 1 Week)
COMPLETED
|
12
|
11
|
|
Washout (at Least 1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (Visit 2)
STARTED
|
12
|
11
|
|
Second Intervention (Visit 2)
COMPLETED
|
12
|
11
|
|
Second Intervention (Visit 2)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Outcomes of Buffered 1% Lidocaine vs. Non-buffered 2% Lidocaine
Baseline characteristics by cohort
| Measure |
All Participants
n=23 Participants
All participants who were randomized to received either Buffered 1% Lidocaine or Non-buffered 2% Lidocaine
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 30 minutes up to 120 minutes totalSubject's Mandibular first molar teeth tested before anesthetic and every 30 minutes after for response to Cold and Electric Pulp Test as reported by subjects as a "yes" or "no."
Outcome measures
| Measure |
Buffered 1% Lidocaine, Then Non-buffered 2% Lidocaine
n=23 Participants
At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).
For this arm, participants first received Buffered 1% Lidocaine followed by a 1-week washout, then Non-buffered 2% Lidocaine.
|
Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine
n=23 Participants
At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).
For this arm, participants first received Non-Buffered 2% Lidocaine followed by a 1-week washout, then Buffered 1% Lidocaine.
|
|---|---|---|
|
Mean Time to Pulpal Response After Mandibular Molar Anesthesia
|
99 Minutes
Standard Deviation 49
|
98 Minutes
Standard Deviation 45
|
PRIMARY outcome
Timeframe: Every 30 minutes up to 120 minutes totalSubject's Mandibular canine teeth will be tested before anesthetic and every 30 minutes after for response to Cold and Electronic Pulp Test for presence of anesthesia as reported by participants "yes" or "no."
Outcome measures
| Measure |
Buffered 1% Lidocaine, Then Non-buffered 2% Lidocaine
n=23 Participants
At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).
For this arm, participants first received Buffered 1% Lidocaine followed by a 1-week washout, then Non-buffered 2% Lidocaine.
|
Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine
n=23 Participants
At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).
For this arm, participants first received Non-Buffered 2% Lidocaine followed by a 1-week washout, then Buffered 1% Lidocaine.
|
|---|---|---|
|
Mean Time to Pulpal Response After Mandibular Canine Anesthesia
|
82 Minutes
Standard Deviation 48
|
85 Minutes
Standard Deviation 48
|
Adverse Events
Buffered 1% Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Buffered 2% Lidocaine
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
Raymond P. White, Jr. DDS, PhD
University of North Carolina at Chapel Hill
Phone: 919-537-3944
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place