Trial Outcomes & Findings for Efficacy Study of Articaine Versus Lidocaine as Supplemental Infiltration in Inflamed Molars (NCT NCT01496846)
NCT ID: NCT01496846
Last Updated: 2017-10-31
Results Overview
Following an unsuccessful IANB, supplemental infiltration anesthesia with either articaine or lidocaine was given to achieve complete pulpal anesthesia
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
201 participants
Primary outcome timeframe
5 min after injection
Results posted on
2017-10-31
Participant Flow
Protocol enrollment: 201 subjects with 1 study tooth.
All enrolled study participants (N=201) initially received an Articaine inferior alveolar nerve block (IANB). If unsuccessful (N=149), this was followed by a supplemental dose (SUP) of either Articaine or Lidocaine. Fifty-two subjects were excluded prior to assignment to groups due to inadequate lip numbness (N=2) or successful IANB (N=50).
Participant milestones
| Measure |
IANB Articaine Only - 1st Molar
IANB anesthesia with articaine local anesthetic provided to 1st Molar.
|
IANB Articaine Only - 2nd Molar
IANB anesthesia with articaine local anesthetic provided to 2nd Molar.
|
IANB Articaine and SUP Articaine - 1st Molar
Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 1st Molar after unsuccessful IANB.
|
IANB Articaine and SUP Articaine - 2nd Molar
Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
|
IANB Articaine and SUP Lidocaine - 1st Molar
Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 1st Molar after unsuccessful IANB.
|
IANB Articaine and SUP Lidocaine - 2nd Molar
Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
|
|---|---|---|---|---|---|---|
|
IANB Articaine (All Participants)
STARTED
|
28
|
24
|
36
|
40
|
35
|
38
|
|
IANB Articaine (All Participants)
COMPLETED
|
27
|
23
|
36
|
40
|
35
|
38
|
|
IANB Articaine (All Participants)
NOT COMPLETED
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Supplemental Buccal Infiltration
STARTED
|
0
|
0
|
36
|
40
|
35
|
38
|
|
Supplemental Buccal Infiltration
COMPLETED
|
0
|
0
|
36
|
40
|
35
|
38
|
|
Supplemental Buccal Infiltration
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
IANB Articaine Only - 1st Molar
IANB anesthesia with articaine local anesthetic provided to 1st Molar.
|
IANB Articaine Only - 2nd Molar
IANB anesthesia with articaine local anesthetic provided to 2nd Molar.
|
IANB Articaine and SUP Articaine - 1st Molar
Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 1st Molar after unsuccessful IANB.
|
IANB Articaine and SUP Articaine - 2nd Molar
Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
|
IANB Articaine and SUP Lidocaine - 1st Molar
Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 1st Molar after unsuccessful IANB.
|
IANB Articaine and SUP Lidocaine - 2nd Molar
Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
|
|---|---|---|---|---|---|---|
|
IANB Articaine (All Participants)
Inadequate lip numbness: "missed" block
|
1
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
Baseline characteristics by cohort
| Measure |
IANB Articaine Only - 1st Molar
n=28 Participants
IANB anesthesia with articaine local anesthetic provided to 1st Molar
|
IANB Articaine Only - 2nd Molar
n=24 Participants
IANB anesthesia with articaine local anesthetic provided to 2nd Molar
|
IANB Articaine and SUP Articaine - 1st Molar
n=36 Participants
Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 1st Molar after unsuccessful IANB.
|
IANB Articaine and SUP Articaine - 2nd Molar
n=40 Participants
Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
|
IANB Articaine and SUP Lidocaine - 1st Molar
n=35 Participants
Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 1st Molar after unsuccessful IANB.
|
IANB Articaine and SUP Lidocaine - 2nd Molar
n=38 Participants
Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 11 • n=27 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
50 years
STANDARD_DEVIATION 18 • n=23 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
40 years
STANDARD_DEVIATION 14 • n=36 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
38 years
STANDARD_DEVIATION 15 • n=40 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
35 years
STANDARD_DEVIATION 14 • n=35 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
40 years
STANDARD_DEVIATION 14 • n=38 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
39 years
STANDARD_DEVIATION 15 • n=199 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
|
Sex: Female, Male
Female
|
13 Participants
n=27 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
13 Participants
n=23 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
12 Participants
n=36 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
23 Participants
n=40 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
22 Participants
n=35 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
19 Participants
n=38 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
102 Participants
n=199 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
|
Sex: Female, Male
Male
|
14 Participants
n=27 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
10 Participants
n=23 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
24 Participants
n=36 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
17 Participants
n=40 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
13 Participants
n=35 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
19 Participants
n=38 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
97 Participants
n=199 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
|
Region of Enrollment
United States
|
27 participants
n=27 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
24 participants
n=23 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
36 participants
n=36 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
40 participants
n=40 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
35 participants
n=35 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
38 participants
n=38 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
199 participants
n=199 Participants • Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine.
|
PRIMARY outcome
Timeframe: 5 min after injectionFollowing an unsuccessful IANB, supplemental infiltration anesthesia with either articaine or lidocaine was given to achieve complete pulpal anesthesia
Outcome measures
| Measure |
IANB Articaine and SUP Articaine - 1st Molar
n=36 Participants
Supplemental buccal anesthesia with articaine local anesthetic provided to 1st Molar after unsuccessful IANB.
|
IANB Articaine and SUP Articaine - 2nd Molar
n=40 Participants
Supplemental buccal anesthesia with articaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
|
IANB Articaine and SUP Lidocaine - 1st Molar
n=35 Participants
Supplemental buccal anesthesia with lidocaine local anesthetic provided to 1st Molar after unsuccessful IANB.
|
IANB Articaine and SUP Lidocaine - 2nd Molar
n=38 Participants
Supplemental buccal anesthesia with lidocaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
|
|---|---|---|---|---|
|
Anesthetic Success Rate of Supplemental Infiltration Injection
|
22 Participants
|
25 Participants
|
23 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 15 min after injectionPopulation: All enrolled participants (N=201) received an IANB with Articaine. Two participants were excluded from data analysis due to inadequate lip numbness (IANB was considered "missed block"); thus N=199 were analyzed for success rate.
Success rate of an IANB with articaine using a conventional IANB technique
Outcome measures
| Measure |
IANB Articaine and SUP Articaine - 1st Molar
n=98 Participants
Supplemental buccal anesthesia with articaine local anesthetic provided to 1st Molar after unsuccessful IANB.
|
IANB Articaine and SUP Articaine - 2nd Molar
n=101 Participants
Supplemental buccal anesthesia with articaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
|
IANB Articaine and SUP Lidocaine - 1st Molar
Supplemental buccal anesthesia with lidocaine local anesthetic provided to 1st Molar after unsuccessful IANB.
|
IANB Articaine and SUP Lidocaine - 2nd Molar
Supplemental buccal anesthesia with lidocaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
|
|---|---|---|---|---|
|
Anesthetic Success Rate of an IANB With Articaine
|
27 Participants
|
23 Participants
|
—
|
—
|
Adverse Events
Initial IANB Articaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SUP Articaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SUP 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
Dr Tatiana Botero, Director of Postgraduate Program in Endodontics
University of Michigan
Phone: 734-936-2526
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place