Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety (SADE-DFA)

University of Southern California

Status: Enrolling

Conditions: Dental Fear and Anxiety

Treatments: Other: Sensory Adapted Dental Environment; Other: Video-based Modeling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06912854

CHLA-24-00096

UH3DE031222 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 312 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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312 participants in 4 patient groups

Regular Dental Environment (RDE)

No Intervention group

Description:

Participants randomized to a RDE will have their dental cleaning administered in a traditional manner (oral examination, prophylaxis, fluoride application) using tell-show-do and basic behavior guidance techniques including positive reinforcement.

Video-based Modeling (VBM)

Experimental group

Description:

Participants randomized to VBM will view a 5-minute video on an iPad that depicts a dental cleaning (oral examination, prophylaxis, and fluoride varnish application) being performed on a sex and age-matched (6-9 yrs v.s 10-12 yrs) cooperative child. This video will feature the model beginning in the waiting room, undertaking a successful cleaning in the absence of any signs of anxiety, choosing a small toy from the dental clinic treasure box, and receiving parental and dentist praise for good behavior.

Treatment:

Other: Video-based Modeling

Sensory Adapted Dental Environment (SADE)

Experimental group

Description:

Participants randomized to the SADE will receive their dental cleaning in a environment in which modifications have been made to visual, auditory, and deep pressure (tactile) stimuli to minimize sensory-related discomforts and maximize relaxation. Visual adaptations include: all direct overhead fluorescent lighting and dental overhead lamp will be turned off; black-out curtains will cover the windows; and application of adapted lighting, which will include slow moving visual color effects (Snoezelen) and the dentist wearing a surgical dental headlamp to direct light into the child's mouth, not eyes. Auditory stimuli will include calming rhythmic music projected via portable speakers. Tactile deep pressure stimuli will be provided via a commercially available weighted blanket placed on the child to provide deep "hugging" pressure, which produces a calming effect.

Treatment:

Other: Sensory Adapted Dental Environment

Video-based Modeling + Sensory Adapted Dental Environment (VBM-SADE)

Experimental group

Description:

Participants randomized to VBM-SADE will view a modeling video prior to their dental cleaning (see Video-based Modeling description) and experience their dental cleaning in a sensory adapted dental environment (see Sensory Adapted Dental Environment description); the pre-cleaning modeling video will portray the same procedural content as in the VBM-only condition, but with the SADE modifications made to the room in which the child actor receives his/her cleaning.

Treatment:

Other: Video-based Modeling

Other: Sensory Adapted Dental Environment