Trial Outcomes & Findings for Virtual Reality in Pediatric Dentistry (NCT NCT05585905)
NCT ID: NCT05585905
Last Updated: 2026-05-18
Results Overview
Behavior and anxiety measured by changed in heart rate were scored at baseline and during sealant placement with virtual reality
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Time from is from baseline until sealant placement with VR
Results posted on
2026-05-18
Participant Flow
Patients were offered enrollment when treatment planned for sealants
Participant milestones
| Measure |
Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side
Virtual Reality (VR) with Right Side Sealants first, then Basic Behavior Guidance (BBG) with Left Side Sealant"
|
VR With Left Side Seals First, Then BBG With Seals on Right Side
Virtual reality with Left Side Sealants first, then basic behavior guidance with Right Side Sealant
|
BBG With Right Side Sealants First, Then VR With Left Side Sealant
Basic behavior guidance with Right Side Sealants first, then virtual reality with Left Side Sealant
|
BBG With Left Side Sealants First, Then VR With Right Side Sealant
Basic behavior guidance with Left Side Sealants first, then virtual reality with Right Side Sealant
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
8
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side
Virtual Reality (VR) with Right Side Sealants first, then Basic Behavior Guidance (BBG) with Left Side Sealant"
|
VR With Left Side Seals First, Then BBG With Seals on Right Side
Virtual reality with Left Side Sealants first, then basic behavior guidance with Right Side Sealant
|
BBG With Right Side Sealants First, Then VR With Left Side Sealant
Basic behavior guidance with Right Side Sealants first, then virtual reality with Left Side Sealant
|
BBG With Left Side Sealants First, Then VR With Right Side Sealant
Basic behavior guidance with Left Side Sealants first, then virtual reality with Right Side Sealant
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
We did not include adults in our inclusion criteria
Baseline characteristics by cohort
| Measure |
Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side
n=4 Participants
Virtual Reality (VR) with Right Side Seals first, then Basic Behavior Guidance (BBG) with Left Side. Basic Behavior guidance. Some of these basic behavior guidance techniques include tell-show-do, ask-tell-ask, memory restructuring, positive pre-visit imagery, and distraction
|
VR With Left Side Seals First, Then BBG With Seals on Right Side
n=4 Participants
Virtual reality with Left Side Sealants first, then basic behavior guidance with Right Side Sealant
|
BBG With Right Side Sealants First, Then VR With Left Side Sealant
n=8 Participants
Basic behavior guidance with Right Side Sealants first, then virtual reality with Left Side Sealant
|
BBG With Left Side Sealants First, Then VR With Right Side Sealant
n=4 Participants
Basic behavior guidance with Left Side Sealants first, then virtual reality with Right Side Sealant
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=4 Participants • We did not include adults in our inclusion criteria
|
4 Participants
n=4 Participants • We did not include adults in our inclusion criteria
|
8 Participants
n=8 Participants • We did not include adults in our inclusion criteria
|
4 Participants
n=4 Participants • We did not include adults in our inclusion criteria
|
20 Participants
n=20 Participants • We did not include adults in our inclusion criteria
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=4 Participants • We did not include adults in our inclusion criteria
|
0 Participants
n=4 Participants • We did not include adults in our inclusion criteria
|
0 Participants
n=8 Participants • We did not include adults in our inclusion criteria
|
0 Participants
n=4 Participants • We did not include adults in our inclusion criteria
|
0 Participants
n=20 Participants • We did not include adults in our inclusion criteria
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants • We did not include adults in our inclusion criteria
|
0 Participants
n=4 Participants • We did not include adults in our inclusion criteria
|
0 Participants
n=8 Participants • We did not include adults in our inclusion criteria
|
0 Participants
n=4 Participants • We did not include adults in our inclusion criteria
|
0 Participants
n=20 Participants • We did not include adults in our inclusion criteria
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Heart Rate Baseline
|
87.7 beats per minute
n=4 Participants • The heart rate between measured before treatment
|
75.25 beats per minute
n=4 Participants • The heart rate between measured before treatment
|
76.6 beats per minute
n=8 Participants • The heart rate between measured before treatment
|
90.75 beats per minute
n=4 Participants • The heart rate between measured before treatment
|
82.575 beats per minute
n=20 Participants • The heart rate between measured before treatment
|
PRIMARY outcome
Timeframe: Time from is from baseline until sealant placement with VRBehavior and anxiety measured by changed in heart rate were scored at baseline and during sealant placement with virtual reality
Outcome measures
| Measure |
BBG With Left Side Sealants First, Then VR With Right Side Sealant
n=4 Participants
Basic behavior guidance with Left Side Sealants first, then virtual reality with Right Side Sealant
|
Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side
n=4 Participants
Virtual Reality (VR) with Right Side Seals first, then Basic Behavior Guidance (BBG) with Left Side. Basic Behavior guidance. Some of these basic behavior guidance techniques include tell-show-do, ask-tell-ask, memory restructuring, positive pre-visit imagery, and distraction
|
VR With Left Side Seals First, Then BBG With Seals on Right Side
n=4 Participants
Virtual reality with Left Side Sealants first, then basic behavior guidance with Right Side Sealant
|
BBG With Right Side Sealants First, Then VR With Left Side Sealant
n=7 Participants
Basic behavior guidance technique with right side sealants first, then virtual reality with left side sealant
|
|---|---|---|---|---|
|
Beats Per Minute Change With VR
|
-6.25 Beats per minute
Interval -12.0 to -3.0
|
-2 Beats per minute
Interval -9.0 to 2.0
|
-6.25 Beats per minute
Interval -9.0 to -4.0
|
-8.8 Beats per minute
Interval -18.0 to 4.0
|
PRIMARY outcome
Timeframe: Time from is from baseline until sealant placement with BBGBehavior and anxiety measured by changed in heart rate were scored at baseline and during sealant placement with basic behavior guidance.
Outcome measures
| Measure |
BBG With Left Side Sealants First, Then VR With Right Side Sealant
n=4 Participants
Basic behavior guidance with Left Side Sealants first, then virtual reality with Right Side Sealant
|
Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side
n=4 Participants
Virtual Reality (VR) with Right Side Seals first, then Basic Behavior Guidance (BBG) with Left Side. Basic Behavior guidance. Some of these basic behavior guidance techniques include tell-show-do, ask-tell-ask, memory restructuring, positive pre-visit imagery, and distraction
|
VR With Left Side Seals First, Then BBG With Seals on Right Side
n=4 Participants
Virtual reality with Left Side Sealants first, then basic behavior guidance with Right Side Sealant
|
BBG With Right Side Sealants First, Then VR With Left Side Sealant
n=7 Participants
Basic behavior guidance technique with right side sealants first, then virtual reality with left side sealant
|
|---|---|---|---|---|
|
Beats Per Minute Change With BBG
|
-0.5 Beats per minute
Interval -16.0 to 7.0
|
-2 Beats per minute
Interval -13.0 to 8.0
|
-2.75 Beats per minute
Interval -10.0 to 1.0
|
-3 Beats per minute
Interval -14.0 to 15.0
|
Adverse Events
Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VR With Left Side Seals First, Then BBG With Seals on Right Side
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BBG With Right Side Sealants First, Then VR With Left Side Sealant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BBG With Left Side Sealants First, Then VR With Right Side Sealant
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