Clinical trial NCT06912854: Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety
Official title: Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Fear and Anxiety
Keywords: sensory adapted dental environment
video-based modeling
dental care
dental anxiety
dental fear
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2025-04-06
Enrollment: 312
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly assigned to one of four study conditions for their first dental cleaning and then be randomly assigned to one of the three remaining study conditions for their second dental cleaning. We will randomize to treatment order and use counterbalancing, statistically adjust for order of cleaning (i.e., first vs. second cleaning), and covary for any significant interactions between order of cleaning and treatment condition.
Primary purpose: OTHER

Brief summary: This study is a randomized clinical trial investigating the effectiveness of a Sensory Adapted Dental Environment (SADE) alone and together with a video-based modeling (VBM) component (VBM-SADE), compared to a regular dental environment (RDE) and/or VBM alone, to reduce anxiety, distress behavior, pain, and sensory discomfort during a dental cleaning in children with and without dental fear and anxiety.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 6 through 12 years, of any race/ethnicity;
* English- or Spanish-speaking child and parent;
* Have experienced at least one prior dental cleaning;
* If recruited from the emergency department, Emergency Severity Index (ESI) must be level V or IV (to ensure that greater severity PED patients not be recruited).

Exclusion Criteria:

* Dental cleaning within the previous 4 months (i.e., not in need of cleaning);
* Plan to move out of the area within 6 months;
* Intellectual or developmental disability (e.g. autism; highly co-morbid with sensory processing difficulties);
* Disability that would interfere with oral care (e.g. cleft lip/palate, cerebral palsy, genetic/endocrine/metabolic dysfunction) or medical condition that would place the child at increased risk during the study (e.g., uncontrollable seizures);
* Daily use of anti-cholinergic drugs (i.e., interferes with EDA recordings);
* Presence of orthodontia (braces) or with a plan to get braces in the upcoming 6 months

Primary outcomes:
measure: Electrodermal Activity (EDA; Skin Conductance Level [SCL])
timeFrame: Periprocedural
measure: Electrodermal Activity (EDA; Non-specific Skin Conductance Responses [NS-SCR])
timeFrame: Periprocedural
measure: Frequency of Distress Behaviors
timeFrame: Periprocedural
measure: Duration of Distress Behaviors
timeFrame: Periprocedural
Secondary outcomes:
measure: Frankl Scale
timeFrame: Collected immediately after each dental cleaning
measure: Anxiety and Cooperation Scale
timeFrame: Collected immediately after each dental cleaning
measure: Wong Baker Faces Pain Scale
timeFrame: Collected immediately after each dental cleaning
measure: Dental Sensory Sensitivity Scale
timeFrame: Collected immediately after each dental cleaning
measure: Subjective Thoroughness of Cleaning Scale
timeFrame: Collected immediately after each dental cleaning
measure: Client Satisfaction Questionnaire
timeFrame: Collected immediately after each dental cleaning
measure: Child Intervention Experience Form
timeFrame: Collected immediately after each dental cleaning
measure: Caregiver Intervention Experience Form
timeFrame: Collected immediately after each dental cleaning
measure: Dentist Intervention Experience Form
timeFrame: Collected immediately after each dental cleaning
measure: State-Trait Anxiety Inventory - Short Form
timeFrame: Collected immediately after each dental cleaning
measure: Stress Appraisal Measure
timeFrame: Collected immediately after each dental cleaning
measure: Semi-Structured Interview of Dentists
timeFrame: Through study completion, an average of 1 year
measure: Children's Fear Survey Schedule - Dental Subscale
timeFrame: Collected prior to participant's first dental cleaning
measure: Short Sensory Profile
timeFrame: Collected prior to participant's first dental cleaning
Other outcomes:
measure: Cleaning Duration
timeFrame: Periprocedural
measure: Added Procedural Costs
timeFrame: Periprocedural
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: University of Southern California
name: Leah Stein Duker, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: