NCT06620289

Brief Summary

The aim of this study is to evaluate whether dental desensitization visits facilitated by a Certified Child Life Specialist (CCLS) significantly impact pediatric patients' distress and cooperation levels from the start of desensitization visit(s) to end of the desensitization visit(s), end of desensitization visit to start of subsequent hygiene appointment, and end of hygiene appointment.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

September 25, 2024

Last Update Submit

April 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frankl Behavioral Rating Scale (FBRS)

    The FBRS is widely used in pediatric dentistry to evaluate patient behavior. FBRS consists of four behavior categories ranging from "definitely positive" to "definitely negative," with higher scores indicating more cooperation. The rating is assigned by the treating pediatric provider and recorded in the patient's medical record at the end of the visit. Participants achieve a scored on a scale ranging from 1 (definitely negative) to 4 (definitely positive).

    From enrollment to the end of study at approximately 3 months.

Secondary Outcomes (5)

  • Pre-Visit Parent Survey

    Before desensitization visit.

  • Repeated Desensitization Visit - Pre-Desensitization Parent Survey

    Before repeated (if applicable) desensitization visits.

  • Sensory Tolerance Checklist

    From enrollment to the end of study at approximately 3 months.

  • The Children's Fear Scale (CFS)

    From enrollment to the end of study at approximately 3 months.

  • Psychosocial Risk Assessment in Pediatrics (PRAP)

    From enrollment to the end of study at approximately 3 months.

Interventions

The goal of offering desensitization visits is to reduce the dental anxiety and distress of patients and enhance their cooperation during future appointments. The specifics of the desensitization are individualized to meet the unique needs of each patient based on information provided by the parent/caregiver. A standard desensitization visit involves providing the patient the opportunity to sit in the exam chair; touch the toothbrush and rubber prophy cup, mouth mirror, fluoride applicator brush, air-water syringe tip and saliva ejector tip; gain exposure to the dental lights and sounds commonly experienced in the dental visit; practice opening their mouth; and tolerate toothbrush and rubber prophy cup, mirror, explorer, fluoride applicator brush, air-water syringe, and salvia ejector in the mouth. If the child is unable or unwilling to participate, these activities are modeled on the parent or by the CCLS.

Eligibility Criteria

Age2 Years - 25 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients and their parents scheduled in the dental center at Children's Hospital Colorado Health Pavillion referred to a child life specialist-facilitated desensitization clinic will be recruited to the study.

You may qualify if:

  • Patients and parents of patients aged 2-25 years who have been referred to the desensitization clinic.
  • Patients who meet with a CCLS for dental desensitization.

You may not qualify if:

  • Patients younger than 2 years old and older than 25 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Certified Child Life Specialist

Study Record Dates

First Submitted

September 25, 2024

First Posted

October 1, 2024

Study Start

August 26, 2024

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations