Trial Outcomes & Findings for Effect of the DentalVibe Injection System on Pain During Local Anesthesia Injections in Children (NCT NCT03374982)
NCT ID: NCT03374982
Last Updated: 2024-01-03
Results Overview
The scale includes pictures of facial expressions with correlating numerical scale of 0-10. 0 being no hurt and 10 being the worst hurt.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Immediately after local anesthetic delivery
Results posted on
2024-01-03
Participant Flow
Participant milestones
| Measure |
DentalVibe Turned On and Then Turned Off
DentalVibe will be turned on during local anesthetic injection at the first appointment. DentalVibe will be turned off at the second appointment
DentalVibe: The DentalVibe is a handheld device that delivers vibration to the tissue during local anesthetic administration.
|
DentalVibe Turned Off and Then Turned On
DentalVibe will be turned off during local anesthetic injection at the first appointment. DentalVibe will be turned on at the second appointment
DentalVibe: The DentalVibe is a handheld device that delivers vibration to the tissue during local anesthetic administration.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sex/gender not recorded
Baseline characteristics by cohort
| Measure |
DentalVibe On, Then Off
n=12 Participants
The DentalVibe is a handheld device that delivers vibration to the tissue during local anesthetic administration.
DentalVibe will be turned on during local anesthetic injection at first assigned appointment, then off at second appointment.
|
DentalVibe Off, Then On
n=11 Participants
The DentalVibe is a handheld device that delivers vibration to the tissue during local anesthetic administration.
DentalVibe will be turned off during local anesthetic injection at first assigned appointment, then on at second appointment.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age (5-11 years)
|
12 Participants
n=12 Participants
|
11 Participants
n=11 Participants
|
23 Participants
n=23 Participants
|
|
Sex/Gender, Customized
Sex/gender unknown
|
0 Participants
Sex/gender not recorded
|
0 Participants
Sex/gender not recorded
|
0 Participants
Sex/gender not recorded
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
11 participants
n=11 Participants
|
23 participants
n=23 Participants
|
PRIMARY outcome
Timeframe: Immediately after local anesthetic deliveryThe scale includes pictures of facial expressions with correlating numerical scale of 0-10. 0 being no hurt and 10 being the worst hurt.
Outcome measures
| Measure |
DentalVibe On
n=23 Participants
DentalVibe will be turned on during local anesthetic injection at one appointment.
DentalVibe: The DentalVibe is a handheld device that delivers vibration to the tissue during local anesthetic administration.
|
DentalVibe Off
n=23 Participants
DentalVibe will be be turned off during local anesthetic injection at one appointment.
|
|---|---|---|
|
Self Reported Pain Rating Using Wong-Baker FACES Scale
|
3.57 score on a scale
Standard Deviation 3.13
|
5.13 score on a scale
Standard Deviation 3.40
|
Adverse Events
DentalVibe On
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DentalVibe Off
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place