Trial Outcomes & Findings for Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Pediatric (NCT NCT03962634)
NCT ID: NCT03962634
Last Updated: 2020-11-19
Results Overview
% dental procedures completed without the need for rescue anesthesia
TERMINATED
PHASE2
3 participants
immediately after dental procedure, an average of 3 hours
2020-11-19
Participant Flow
Participant milestones
| Measure |
Kovanaze Nasal Spray (Pediatrics)
Children \>20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth
Kovanaze Nasal Spray: Intra-nasal local anesthetic
|
Articaine Injections (Pediatrics)
Children \>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth
Articaine Injection: Local anesthetic
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Baseline characteristics by cohort
| Measure |
Kovanaze Nasal Spray (Pediatrics)
n=1 Participants
Children \>20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth
Kovanaze Nasal Spray: Intra-nasal local anesthetic
|
Articaine Injections (Pediatrics)
n=2 Participants
Children \>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth
Articaine Injection: Local anesthetic
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
0 Participants
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
|
0 Participants
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
|
0 Participants
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
|
|
Sex: Female, Male
Male
|
0 Participants
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
|
0 Participants
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
|
0 Participants
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
2 participants
n=2 Participants
|
3 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: immediately after dental procedure, an average of 3 hoursPopulation: Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
% dental procedures completed without the need for rescue anesthesia
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: immediately after dental procedure, an average of 3 hoursPopulation: Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Number of teeth anesthetized in maxillary arch
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to immediately after dental procedurePopulation: Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
STAI-Y6 - 6 item youth questionnaire assessing anxiety on a 4 point scale ranging from 1 (Not at all) to 4 (very much). Scores range from 6 to 24.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: immediately after dental procedure, an average of 3 hoursPopulation: Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Venham Behavior rating scale - single item 6 point scale used by provider to rate child's behavior during treatment. Item ranges from 0 (no protest) to 5 (high protest, no cooperation from child)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to immediately after dental procedurePopulation: Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to immediately after dental procedurePopulation: Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to immediately after dental procedurePopulation: Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Emoji scale ranging from 1 (very negative face) to 7 (very positive face)
Outcome measures
Outcome data not reported
Adverse Events
Kovanaze Nasal Spray (Pediatrics)
Articaine Injections (Pediatrics)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Parthasarathy Madurantakam
Virginia Commonwealth University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place