Trial Outcomes & Findings for Sensory Adapted Dental Environments to Enhance Oral Care for Children (NCT NCT02430051)
NCT ID: NCT02430051
Last Updated: 2025-08-19
Results Overview
Electrodermal activity (EDA) is a non-invasive measure of the ability of the skin to conduct an electrical current, which increases when the sympathetic "fight or flight" nervous system is activated during times of stress.
COMPLETED
NA
220 participants
Recorded continuously for three minutes prior to cleaning, through duration of cleaning (approximately 10-45 minutes), and for three minutes at end of cleaning for each dental cleaning.
2025-08-19
Participant Flow
Participants were recruited from health clinics (eg, CHLA dental clinic), community service providers (eg, developmental disability service providers, resource fairs), therapy and behavioral clinics, patient referrals, parent support groups, social media, and the Los Angeles Unified School District.
Participant milestones
| Measure |
Regular Dental Environment First, Then Sensory Adapted Dental Environment
Dental Visit #1 (Day 5-95):
Participants received their first dental cleaning in the Regular Dental Environment (RDE). In this condition, no sensory characteristics of the dental environment are altered and the cleaning is conducted in a standard manner (oral examination, prophylaxis, fluoride).
Dental Visit #2 (Day 125-215):
Participants received their second dental cleaning in the Sensory Adapted Dental Environment (SADE) approximately 6 months after their first dental cleaning. In the SADE, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations) including dimming lighting, moving projections on the ceiling, exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide a calming sensation.
|
Sensory Adapted Dental Environment First, Then Regular Dental Environment
Dental Visit #1 (Day 5-95):
Participants received their first dental cleaning in the Sensory Adapted Dental Environment (SADE). In the SADE, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations) including dimming lighting, moving projections on the ceiling, exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide a calming sensation.
Dental Visit #2 (Day 125-215):
Participants received their second dental cleaning in the Regular Dental Environment (RDE) approximately 6 months after their first dental cleaning. In this condition, no sensory characteristics of the dental environment are altered and the cleaning is conducted in a standard manner (oral examination, prophylaxis, fluoride).
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
80
|
|
Overall Study
Second Dental Visit
|
70
|
68
|
|
Overall Study
COMPLETED
|
70
|
68
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
| Measure |
Regular Dental Environment First, Then Sensory Adapted Dental Environment
Dental Visit #1 (Day 5-95):
Participants received their first dental cleaning in the Regular Dental Environment (RDE). In this condition, no sensory characteristics of the dental environment are altered and the cleaning is conducted in a standard manner (oral examination, prophylaxis, fluoride).
Dental Visit #2 (Day 125-215):
Participants received their second dental cleaning in the Sensory Adapted Dental Environment (SADE) approximately 6 months after their first dental cleaning. In the SADE, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations) including dimming lighting, moving projections on the ceiling, exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide a calming sensation.
|
Sensory Adapted Dental Environment First, Then Regular Dental Environment
Dental Visit #1 (Day 5-95):
Participants received their first dental cleaning in the Sensory Adapted Dental Environment (SADE). In the SADE, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations) including dimming lighting, moving projections on the ceiling, exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide a calming sensation.
Dental Visit #2 (Day 125-215):
Participants received their second dental cleaning in the Regular Dental Environment (RDE) approximately 6 months after their first dental cleaning. In this condition, no sensory characteristics of the dental environment are altered and the cleaning is conducted in a standard manner (oral examination, prophylaxis, fluoride).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
|
Overall Study
Dropped due to not meeting scheduling requirements
|
6
|
9
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Sensory Adapted Dental Environments to Enhance Oral Care for Children
Baseline characteristics by cohort
| Measure |
Regular Dental Environment First, Then Sensory Adapted Dental Environment
n=70 Participants
Dental Visit #1 (Day 5-95) Participants received their first dental cleaning in the Regular Dental Environment (RDE). In this condition, no sensory characteristics of the dental environment are altered and the cleaning is conducted in a standard manner (oral examination, prophylaxis, fluoride).
Dental Visit #2 (Day 125-215) Participants received their second dental cleaning in the Sensory Adapted Dental Environment (SADE) approximately 6 months after their first dental cleaning. In the SADE, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations) including dimming lighting, moving projections on the ceiling, exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide a calming sensation.
|
Sensory Adapted Dental Environment First, Then Regular Dental Environment
n=68 Participants
Dental Visit #1 (Day 5-95) Participants received their first dental cleaning in the Sensory Adapted Dental Environment (SADE). In the SADE, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations) including dimming lighting, moving projections on the ceiling, exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide a calming sensation.
Dental Visit #2 (Day 125-215) Participants received their second dental cleaning in the Regular Dental Environment (RDE) approximately 6 months after their first dental cleaning. In this condition, no sensory characteristics of the dental environment are altered and the cleaning is conducted in a standard manner (oral examination, prophylaxis, fluoride).
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.19 years
STANDARD_DEVIATION 2.04 • n=93 Participants
|
9.33 years
STANDARD_DEVIATION 1.93 • n=4 Participants
|
9.26 years
STANDARD_DEVIATION 1.98 • n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
114 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
50 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
105 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=93 Participants
|
68 participants
n=4 Participants
|
138 participants
n=27 Participants
|
|
Autism Diagnostic Observation Schedule-2 (ADOS-2) Severity Score
|
6.19 score on a scale
STANDARD_DEVIATION 1.78 • n=93 Participants
|
6.65 score on a scale
STANDARD_DEVIATION 1.89 • n=4 Participants
|
6.41 score on a scale
STANDARD_DEVIATION 1.84 • n=27 Participants
|
|
Wechsler Abbreviated Scale of Intelligence (WASI-II) Full Scale Intelligence Quotient (FSIQ4)
|
74.71 score on a scale
STANDARD_DEVIATION 23.14 • n=93 Participants
|
71.56 score on a scale
STANDARD_DEVIATION 24.40 • n=4 Participants
|
73.16 score on a scale
STANDARD_DEVIATION 23.73 • n=27 Participants
|
|
Vineland Adaptive Behavior Scales (VABS-II) Expressive Communication
|
64.97 score on a scale
STANDARD_DEVIATION 29.15 • n=93 Participants
|
63.63 score on a scale
STANDARD_DEVIATION 27.29 • n=4 Participants
|
64.31 score on a scale
STANDARD_DEVIATION 28.15 • n=27 Participants
|
|
Sensory Over-Responsitivty (SensOR) Inventory Total
|
25.36 units on a scale
STANDARD_DEVIATION 12.95 • n=93 Participants
|
29.46 units on a scale
STANDARD_DEVIATION 13.91 • n=4 Participants
|
27.38 units on a scale
STANDARD_DEVIATION 13.54 • n=27 Participants
|
|
Child and Adolescent Symptom Inventory-4 Autism Anxiety Scale (CASI-Anx)
|
18.55 score on a scale
STANDARD_DEVIATION 9.91 • n=93 Participants
|
21.39 score on a scale
STANDARD_DEVIATION 10.47 • n=4 Participants
|
19.95 score on a scale
STANDARD_DEVIATION 10.25 • n=27 Participants
|
|
Children's Fear Survey Schedule - Dental Subscale (CFSS-DS)
|
45.94 score on a scale
STANDARD_DEVIATION 14.92 • n=93 Participants
|
49.25 score on a scale
STANDARD_DEVIATION 12.10 • n=4 Participants
|
47.57 score on a scale
STANDARD_DEVIATION 13.66 • n=27 Participants
|
|
Diagnoses
ADHD
|
16 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Diagnoses
Other Diagnoses
|
27 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Mother's education
<High school
|
8 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Mother's education
High school
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Mother's education
Some college of vocational
|
28 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Mother's education
College degree
|
22 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Father's education
<High school
|
7 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Father's education
High school
|
21 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Father's education
Some college or vocational
|
18 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Father's education
College degree
|
17 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Father's education
Not provided
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Recorded continuously for three minutes prior to cleaning, through duration of cleaning (approximately 10-45 minutes), and for three minutes at end of cleaning for each dental cleaning.Population: As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 248 analyzable observations for EDA SCLs.
Electrodermal activity (EDA) is a non-invasive measure of the ability of the skin to conduct an electrical current, which increases when the sympathetic "fight or flight" nervous system is activated during times of stress.
Outcome measures
| Measure |
Regular Dental Environment
n=127 Participants
There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.
|
Sensory Adapted Dental Environment
n=121 Participants
In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).
Sensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.
|
|---|---|---|
|
Electrodermal Activity (EDA) - Skin Conductance Level (SCL)
|
8.96 microsiemens (µS)
Standard Deviation 5.29
|
7.74 microsiemens (µS)
Standard Deviation 4.85
|
PRIMARY outcome
Timeframe: Recorded continuously for three minutes prior to cleaning, through duration of cleaning (approximately 10-45 minutes), and for three minutes at end of cleaning for each dental cleaning.Population: As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 245 analyzable observations for EDA NS-SCRs.
Electrodermal activity (EDA) is a non-invasive measure of the ability of the skin to conduct an electrical current, which increases when the sympathetic "fight or flight" nervous system is activated during times of stress. Each unique increase \>0.05uS in the EDA waveform is counted as an NS-SCR, indicating a increase in sympathetic nervous system activation; NS-SCRs are measured as a frequency per minute (calculated as the number of NS-SCRs/time).
Outcome measures
| Measure |
Regular Dental Environment
n=125 Participants
There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.
|
Sensory Adapted Dental Environment
n=120 Participants
In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).
Sensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.
|
|---|---|---|
|
Electrodermal Activity (EDA) - Non-specific Skin Conductance Responses (NS-SCR)
|
4.25 number of NS-SCRs per minute (frequency)
Standard Deviation 3.03
|
3.90 number of NS-SCRs per minute (frequency)
Standard Deviation 2.72
|
SECONDARY outcome
Timeframe: Videorecorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.Population: As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 276 analyzable observations for CDBRS.
The CDBRS is a video-coded measure of overt distress behaviors exhibited by children during a routine dental visit. A research team member marks the presence or absence of three distress behaviors (mouth movement, head movement, forehead movement) and the presence or absence and the severity of two distress behaviors (whimper/cry/scream, verbal stall or delay) during each one-minute interval of a five-minute recording of a child receiving prophylaxis during their dental cleaning. Coding is conducted by a trained research team member who achieves strong inter-rater reliability with a second trained rater on a representative sample of children with and without ASD. Raw scores (range=0-45) are converted to a scale score ranging from 1 to 100, with higher scores indicating greater distress.
Outcome measures
| Measure |
Regular Dental Environment
n=138 Participants
There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.
|
Sensory Adapted Dental Environment
n=138 Participants
In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).
Sensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.
|
|---|---|---|
|
Children's Dental Behavior Rating Scale (CDBRS)
|
46.41 score on a scale
Standard Deviation 11.78
|
46.10 score on a scale
Standard Deviation 10.77
|
SECONDARY outcome
Timeframe: Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.Population: As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 276 analyzable observations for whimper, cry, scream duration.
Duration of whimpers, cries, or screams, as scored by video coding.
Outcome measures
| Measure |
Regular Dental Environment
n=138 Participants
There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.
|
Sensory Adapted Dental Environment
n=138 Participants
In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).
Sensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.
|
|---|---|---|
|
Whimper, Cry, Scream Duration
|
44.26 minutes
Standard Deviation 68.39
|
19.70 minutes
Standard Deviation 43.56
|
SECONDARY outcome
Timeframe: Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.Population: As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 276 analyzable observations for whimper, cry, scream frequency.
Frequency of whimpers, cries, or screams, as scored by video coding.
Outcome measures
| Measure |
Regular Dental Environment
n=138 Participants
There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.
|
Sensory Adapted Dental Environment
n=138 Participants
In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).
Sensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.
|
|---|---|---|
|
Whimper, Cry, Scream Frequency
|
9.83 events
Standard Deviation 9.96
|
6.02 events
Standard Deviation 7.10
|
SECONDARY outcome
Timeframe: Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.Population: As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 276 analyzable observations for mouth movement frequency.
Frequency of mouth movement impeding treatment, as scored by video coding.
Outcome measures
| Measure |
Regular Dental Environment
n=138 Participants
There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.
|
Sensory Adapted Dental Environment
n=138 Participants
In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).
Sensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.
|
|---|---|---|
|
Mouth Movement Frequency
|
5.43 events
Standard Deviation 6.32
|
3.20 events
Standard Deviation 4.15
|
SECONDARY outcome
Timeframe: Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.Population: As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 276 analyzable observations for head movement frequency.
Frequency of head movement away from the dentist and/or equipment impeding treatment, as scored by video coding.
Outcome measures
| Measure |
Regular Dental Environment
n=138 Participants
There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.
|
Sensory Adapted Dental Environment
n=138 Participants
In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).
Sensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.
|
|---|---|---|
|
Head Movement Frequency
|
16.36 events
Standard Deviation 19.39
|
11.68 events
Standard Deviation 13.92
|
SECONDARY outcome
Timeframe: Completed at the end of each dental cleaning (approximately 1-2 minutes)Population: As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 114 usable scores for the Faces Pain Scale-Revised.
The Faces Pain Scale - Revised is single-item self-report measure used to assess the perception and intensity of pain in children. The scale is comprised of six faces depicting increasing levels of pain ranging from a neutral expression (no pain) to a face showing severe pain. Each face corresponds to a numerical value on a 0-10 scale (0, 2, 4, 6, 8, 10). Higher scores indicate greater perception and intensity of pain.
Outcome measures
| Measure |
Regular Dental Environment
n=57 Participants
There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.
|
Sensory Adapted Dental Environment
n=57 Participants
In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).
Sensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.
|
|---|---|---|
|
Faces Pain Scale - Revised
|
2.37 score on a scale
Standard Deviation 3.50
|
2.14 score on a scale
Standard Deviation 3.13
|
SECONDARY outcome
Timeframe: Completed at the end of each dental cleaning (approximately 3 minutes)Population: As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 106 usable scores for the Dental Sensory Sensitivity Scale.
The Dental Sensory Sensitivity Scale is a child-report measure assessing the presence and magnitude of discomfort with different sensory stimuli in the dental environment (i.e., tactile, auditory, proprioceptive). The scale is comprised of 6 items rated on a 3-point Likert scale ranging from 0 (not at all) to 2 (a lot). Scores range from 0 - 12 with higher scores indicating greater sensory discomfort during routine dental treatment.
Outcome measures
| Measure |
Regular Dental Environment
n=53 Participants
There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.
|
Sensory Adapted Dental Environment
n=53 Participants
In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).
Sensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.
|
|---|---|---|
|
Dental Sensory Sensitivity Scale
|
3.68 score on a scale
Standard Deviation 3.06
|
3.06 score on a scale
Standard Deviation 2.74
|
SECONDARY outcome
Timeframe: Completed at the end of each dental cleaning (approximately 1 minute)Population: As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 276 usable scores for the Anxiety and Cooperation Scale.
The Anxiety and Cooperation Scale (A \& C Scale) has been shown to assess children's anxiety, fear, and cooperation as rated by dentists, and has good established reliability and validity. Following a routine dental cleaning, the dentist rated overall patient behavior during treatment using a one-item Likert scale ranging from 0 (relaxed, smiling, demonstrates desired behavior, complies with demands) to 5 (out of control, loud crying, reverts to primitive flight responses, physical restraint required).
Outcome measures
| Measure |
Regular Dental Environment
n=138 Participants
There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.
|
Sensory Adapted Dental Environment
n=138 Participants
In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).
Sensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.
|
|---|---|---|
|
Anxiety and Cooperation Scale
|
2.03 score on a scale
Standard Deviation 1.77
|
1.88 score on a scale
Standard Deviation 1.61
|
SECONDARY outcome
Timeframe: Completed at the end of each dental cleaning (approximately 1 minute)Population: As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 276 usable scores for Frankl Scale.
The Frankl Scale is dentist-report measure of a child's overall behavior during a dental visit. It is an observational, single-item measure that includes four behavioral categories, each assigned a numerical value (1=definitely negative, 2=negative, 3=positive, 4=definitely positive). Higher scores indicate greater cooperation and less distress.
Outcome measures
| Measure |
Regular Dental Environment
n=138 Participants
There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.
|
Sensory Adapted Dental Environment
n=138 Participants
In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).
Sensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.
|
|---|---|---|
|
Frankl Scale
|
2.61 score on a scale
Standard Deviation 1.01
|
2.68 score on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Time from beginning to end of dental cleaning (approximately 10-45 minutes); recorded for each visitPopulation: As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 252 analyzable durations.
The length of time to complete the dental cleaning. Used for cost-analysis of the intervention.
Outcome measures
| Measure |
Regular Dental Environment
n=126 Participants
There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.
|
Sensory Adapted Dental Environment
n=126 Participants
In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).
Sensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.
|
|---|---|---|
|
Duration
|
10.51 minutes
Standard Deviation 3.86
|
10.20 minutes
Standard Deviation 4.14
|
SECONDARY outcome
Timeframe: Recorded throughout the dental cleaning (approximately 10-45 minutes)Population: As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 302 analyzable data points.
The maximum number of hands (at any one time) required to restrain the child during the dental cleaning experience was utilized as a measure of cost and also a measure of uncooperative behavior. This variable was recorded on researcher notes during the dental cleaning and was verified using the videotape of the dental cleaning. Scoring included presence/absence as well as the number of hands used for restraint purposes during the cleaning.
Outcome measures
| Measure |
Regular Dental Environment
n=153 Participants
There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.
|
Sensory Adapted Dental Environment
n=149 Participants
In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).
Sensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.
|
|---|---|---|
|
Number of Hands Used to Restrain Child
|
2.14 hands
Standard Deviation 2.64
|
1.83 hands
Standard Deviation 2.32
|
Adverse Events
Regular Dental Environment
Sensory Adapted Dental Environment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Leah Stein Duker
University of Southern California
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place