Autism
Conditions
Keywords
sensory processing, oral care, electrodermal activity, cooperation, anxiety, distress, stress, behavior, occupational therapy
Brief summary
The goal of this project is to examine the efficacy of a sensory adapted dental environment (SADE) for children who have difficulty tolerating oral care in the dental clinic. The investigators hypothesize that adapting the sensory environment in the dental office by modifying the sounds, sights,and tactile experiences will result in decreased anxiety, increased cooperation, and fewer behavior problems for children with Autism Spectrum Disorders (ASD). This has the potential to contribute to increased child comfort as well as safer, more efficient, and less costly treatment for a large population, as potentially more than one-fourth of all children may benefit from a sensory adapted dental environment.
Detailed description
This project, which builds upon the investigator's previous R34 National Institute of Dental and Craniofacial Research (NIDCR) Planning and Feasibility study, is designed to examine the efficacy of a sensory adapted dental environment (SADE) to enhance oral care for children with autism spectrum disorders (ASD). Children with ASD often exhibit sensory over-responsivity when confronted with experiential aspects of dental visits such as exposure to bright fluorescent lighting, touch in or around the mouth, or the texture and smell of various oral care products. This often results in increased anxiety and negative behavioral responses which hinder the dentist's ability to perform treatment. In the proposed project, the investigators test a SADE intervention designed to reduce children's anxiety and negative responses during oral care. 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. The specific aims are to conduct a randomized clinical trial in order to: 1. Determine if SADE, relative to a regular dental environment (RDE), reduces physiological anxiety and negative responses (behavioral distress, perception of pain, sensory discomfort) during dental cleaning for children with ASD. 2. Identify whether physiological anxiety mediates the beneficial effects of the intervention and whether severity of ASD and communication ability, or dental anxiety, sensory over-responsivity, and age act as moderating variables. 3. Assess the quality of care and cost effectiveness/savings of the dental cleaning associated with SADE. Research participants will be 220 ethnically diverse children aged 6-12 years. Using a randomized counterbalanced study design, each child will undergo two dental cleanings four months apart: one dental cleaning in RDE and one dental cleaning in SADE. This project is significant because it is the first full-scale trial of an intervention designed to reduce oral care problems in children with ASD. It is theoretically important because it will elucidate the mechanisms that underlie the effects of the SADE intervention. Based on the study findings, the investigators will develop a model to transform the standard of pediatric dental care by modifying the sensory qualities of the dental environment. This model will have the potential to be utilized in dental clinics worldwide. As such, the project promises to have a major public health impact insofar as the potential gains in oral health, child comfort, and cost-savings will be dramatic, potentially applying to more than one-fourth of all children.
Interventions
BEHAVIORALSensory 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.
Sponsors
Children's Hospital Los Angeles
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of autism using ADOS; * Parents speak English or Spanish; * Have experienced at least one prior dental cleaning; * In need of an oral cleaning (no previous cleaning within past four months).
Exclusion criteria
* Cleft palate or other oral condition which makes dental care more difficult than usual practice; * Prescription of anti-cholinergic drugs (which may alter EDA); * Presence of orthodontia (braces); * Significant motor impairment, such as cerebral palsy; * Any known genetic, endocrine, or metabolic dysfunctions; * Participation in the R34 SADE pilot study; * Any medical condition such as significant cardiac problems that would place the individual at increased risk in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electrodermal Activity (EDA) - Skin Conductance Level (SCL) | 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. | 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. |
| Electrodermal Activity (EDA) - Non-specific Skin Conductance Responses (NS-SCR) | 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. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Whimper, Cry, Scream Frequency | Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis. | Frequency of whimpers, cries, or screams, as scored by video coding. |
| Mouth Movement Frequency | Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis. | Frequency of mouth movement impeding treatment, as scored by video coding. |
| Head Movement Frequency | Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis. | Frequency of head movement away from the dentist and/or equipment impeding treatment, as scored by video coding. |
| Faces Pain Scale - Revised | Completed at the end of each dental cleaning (approximately 1-2 minutes) | 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. |
| Children's Dental Behavior Rating Scale (CDBRS) | Videorecorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis. | 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. |
| Anxiety and Cooperation Scale | Completed at the end of each dental cleaning (approximately 1 minute) | 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). |
| Frankl Scale | Completed at the end of each dental cleaning (approximately 1 minute) | 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. |
| Duration | Time from beginning to end of dental cleaning (approximately 10-45 minutes); recorded for each visit | The length of time to complete the dental cleaning. Used for cost-analysis of the intervention. |
| Number of Hands Used to Restrain Child | Recorded throughout the dental cleaning (approximately 10-45 minutes) | 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. |
| Dental Sensory Sensitivity Scale | Completed at the end of each dental cleaning (approximately 3 minutes) | 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. |
| Whimper, Cry, Scream Duration | Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis. | Duration of whimpers, cries, or screams, as scored by video coding. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 70 |
| 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). | 68 |
| Total | 138 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Dropped due to not meeting scheduling requirements | 6 | 9 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 3 |
Baseline characteristics
| Characteristic | Regular Dental Environment First, Then Sensory Adapted Dental Environment | Sensory Adapted Dental Environment First, Then Regular Dental Environment | Total |
|---|---|---|---|
| Age, Continuous | 9.19 years STANDARD_DEVIATION 2.04 | 9.33 years STANDARD_DEVIATION 1.93 | 9.26 years STANDARD_DEVIATION 1.98 |
| Autism Diagnostic Observation Schedule-2 (ADOS-2) Severity Score | 6.19 score on a scale STANDARD_DEVIATION 1.78 | 6.65 score on a scale STANDARD_DEVIATION 1.89 | 6.41 score on a scale STANDARD_DEVIATION 1.84 |
| Child and Adolescent Symptom Inventory-4 Autism Anxiety Scale (CASI-Anx) | 18.55 score on a scale STANDARD_DEVIATION 9.91 | 21.39 score on a scale STANDARD_DEVIATION 10.47 | 19.95 score on a scale STANDARD_DEVIATION 10.25 |
| Children's Fear Survey Schedule - Dental Subscale (CFSS-DS) | 45.94 score on a scale STANDARD_DEVIATION 14.92 | 49.25 score on a scale STANDARD_DEVIATION 12.1 | 47.57 score on a scale STANDARD_DEVIATION 13.66 |
| Diagnoses ADHD | 16 Participants | 10 Participants | 26 Participants |
| Diagnoses Other Diagnoses | 27 Participants | 27 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 50 Participants | 47 Participants | 97 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 21 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Father's education College degree | 17 Participants | 16 Participants | 33 Participants |
| Father's education <High school | 7 Participants | 14 Participants | 21 Participants |
| Father's education High school | 21 Participants | 15 Participants | 36 Participants |
| Father's education Not provided | 7 Participants | 10 Participants | 17 Participants |
| Father's education Some college or vocational | 18 Participants | 13 Participants | 31 Participants |
| Mother's education College degree | 22 Participants | 19 Participants | 41 Participants |
| Mother's education <High school | 8 Participants | 12 Participants | 20 Participants |
| Mother's education High school | 12 Participants | 10 Participants | 22 Participants |
| Mother's education Some college of vocational | 28 Participants | 27 Participants | 55 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 8 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 53 Participants | 52 Participants | 105 Participants |
| Region of Enrollment United States | 70 participants | 68 participants | 138 participants |
| Sensory Over-Responsitivty (SensOR) Inventory Total | 25.36 units on a scale STANDARD_DEVIATION 12.95 | 29.46 units on a scale STANDARD_DEVIATION 13.91 | 27.38 units on a scale STANDARD_DEVIATION 13.54 |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 58 Participants | 56 Participants | 114 Participants |
| Vineland Adaptive Behavior Scales (VABS-II) Expressive Communication | 64.97 score on a scale STANDARD_DEVIATION 29.15 | 63.63 score on a scale STANDARD_DEVIATION 27.29 | 64.31 score on a scale STANDARD_DEVIATION 28.15 |
| Wechsler Abbreviated Scale of Intelligence (WASI-II) Full Scale Intelligence Quotient (FSIQ4) | 74.71 score on a scale STANDARD_DEVIATION 23.14 | 71.56 score on a scale STANDARD_DEVIATION 24.4 | 73.16 score on a scale STANDARD_DEVIATION 23.73 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 151 | 0 / 150 |
| other Total, other adverse events | 0 / 151 | 0 / 150 |
| serious Total, serious adverse events | 0 / 151 | 0 / 150 |
Outcome results
Primary
Electrodermal Activity (EDA) - Non-specific Skin Conductance Responses (NS-SCR)
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular Dental Environment | Electrodermal Activity (EDA) - Non-specific Skin Conductance Responses (NS-SCR) | 4.25 number of NS-SCRs per minute (frequency) | Standard Deviation 3.03 |
| Sensory Adapted Dental Environment | Electrodermal Activity (EDA) - Non-specific Skin Conductance Responses (NS-SCR) | 3.90 number of NS-SCRs per minute (frequency) | Standard Deviation 2.72 |
p-value: 0.25Mixed-effects regression model
Primary
Electrodermal Activity (EDA) - Skin Conductance Level (SCL)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular Dental Environment | Electrodermal Activity (EDA) - Skin Conductance Level (SCL) | 8.96 microsiemens (µS) | Standard Deviation 5.29 |
| Sensory Adapted Dental Environment | Electrodermal Activity (EDA) - Skin Conductance Level (SCL) | 7.74 microsiemens (µS) | Standard Deviation 4.85 |
p-value: 0.01Mixed-effects regression model
Secondary
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular Dental Environment | Anxiety and Cooperation Scale | 2.03 score on a scale | Standard Deviation 1.77 |
| Sensory Adapted Dental Environment | Anxiety and Cooperation Scale | 1.88 score on a scale | Standard Deviation 1.61 |
p-value: 0.76Wilcoxon (Mann-Whitney)
Secondary
Children's Dental Behavior Rating Scale (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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular Dental Environment | Children's Dental Behavior Rating Scale (CDBRS) | 46.41 score on a scale | Standard Deviation 11.78 |
| Sensory Adapted Dental Environment | Children's Dental Behavior Rating Scale (CDBRS) | 46.10 score on a scale | Standard Deviation 10.77 |
p-value: 0.87Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular Dental Environment | Dental Sensory Sensitivity Scale | 3.68 score on a scale | Standard Deviation 3.06 |
| Sensory Adapted Dental Environment | Dental Sensory Sensitivity Scale | 3.06 score on a scale | Standard Deviation 2.74 |
p-value: 0.16Wilcoxon (Mann-Whitney)
Secondary
Duration
The length of time to complete the dental cleaning. Used for cost-analysis of the intervention.
Time frame: Time from beginning to end of dental cleaning (approximately 10-45 minutes); recorded for each visit
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular Dental Environment | Duration | 10.51 minutes | Standard Deviation 3.86 |
| Sensory Adapted Dental Environment | Duration | 10.20 minutes | Standard Deviation 4.14 |
p-value: <0.0001Multivariate linear regression
Secondary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular Dental Environment | Faces Pain Scale - Revised | 2.37 score on a scale | Standard Deviation 3.5 |
| Sensory Adapted Dental Environment | Faces Pain Scale - Revised | 2.14 score on a scale | Standard Deviation 3.13 |
p-value: 0.92Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular Dental Environment | Frankl Scale | 2.61 score on a scale | Standard Deviation 1.01 |
| Sensory Adapted Dental Environment | Frankl Scale | 2.68 score on a scale | Standard Deviation 0.98 |
p-value: 0.8Wilcoxon (Mann-Whitney)
Secondary
Head Movement Frequency
Frequency of head movement away from the dentist and/or equipment impeding treatment, as scored by video coding.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular Dental Environment | Head Movement Frequency | 16.36 events | Standard Deviation 19.39 |
| Sensory Adapted Dental Environment | Head Movement Frequency | 11.68 events | Standard Deviation 13.92 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Mouth Movement Frequency
Frequency of mouth movement impeding treatment, as scored by video coding.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular Dental Environment | Mouth Movement Frequency | 5.43 events | Standard Deviation 6.32 |
| Sensory Adapted Dental Environment | Mouth Movement Frequency | 3.20 events | Standard Deviation 4.15 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Number of Hands Used to Restrain Child
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular Dental Environment | Number of Hands Used to Restrain Child | 2.14 hands | Standard Deviation 2.64 |
| Sensory Adapted Dental Environment | Number of Hands Used to Restrain Child | 1.83 hands | Standard Deviation 2.32 |
p-value: 0.61General linear mixed model
Secondary
Whimper, Cry, Scream Duration
Duration of whimpers, cries, or screams, as scored by video coding.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular Dental Environment | Whimper, Cry, Scream Duration | 44.26 minutes | Standard Deviation 68.39 |
| Sensory Adapted Dental Environment | Whimper, Cry, Scream Duration | 19.70 minutes | Standard Deviation 43.56 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Whimper, Cry, Scream Frequency
Frequency of whimpers, cries, or screams, as scored by video coding.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular Dental Environment | Whimper, Cry, Scream Frequency | 9.83 events | Standard Deviation 9.96 |
| Sensory Adapted Dental Environment | Whimper, Cry, Scream Frequency | 6.02 events | Standard Deviation 7.1 |
p-value: <0.001Wilcoxon (Mann-Whitney)