NCT07719205

Brief Summary

In pediatric dentistry, our primary goals are to prevent dental caries and, when necessary, provide treatment in a safe and comforting environment that minimizes anxiety for young patients. By familiarizing young patients with the steps involved in common dental procedures, tactile pre-visit imagery booklets can reduce the fear of the unknown. Study Objective/Purpose: The purpose of this study is to determine whether tactile pre-visit imagery could reduce dental anxiety and fear in pediatric patients prior to their first restorative procedure. An additional aspect of this study entails assessing the patient's behavior and determining if it improves with the use of a tactile pre-visit imagery booklet.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress23%
Jan 2026Jun 2028

Study Start

First participant enrolled

January 15, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Expected
Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 13, 2026

Last Update Submit

July 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dental Anxiety

    Change in dental anxiety before and after treatment. The Venham Picture test is used to measure the child's anxiety. The scores from the Venham Picture test will be compared between pre- and post- treatment to determine changes in dental anxiety.

    At baseline (pre-intervention) and immediately after treatment (post-intervention)

Secondary Outcomes (1)

  • Change in Behavior

    At baseline (preintervention) and immediately after treatment (post-intervention)

Study Arms (2)

Tactile Previsit Imagery

EXPERIMENTAL

Receives tactile previsit imagery booklet

Behavioral: Tactile Previsit Imagery Booklet

No Tactile Previsit Imagery

NO INTERVENTION

No additional previsit imagery

Interventions

Physical Booklet that walks patient through all materials used during the dental treatmne and contains physical items that are going to be used so that patient can touch and feel.

Tactile Previsit Imagery

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 4-10 years
  • ASA I or II
  • Patients who have NOT had dental treatment before
  • Patients needing at least ONE composite filling or stainless steel crown \[CP1\] with nitrous oxide and local anesthesia (composite filling must be done at the first treatment visit)
  • Parents and children must speak English or Spanish

You may not qualify if:

  • Children with developmental delays or cognitive impairments that may impact their ability to participate in pre-visit imagery activities
  • Patients with visual or tactile disabilities associated for a particular medical condition or as reported on their medical history form
  • Patients who refuse to wear nitrous hood
  • Emergency dental appointments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

USC Herman Ostrow School of Dentistry - Pediatric Dental Clinic

Los Angeles, California, 90089, United States

RECRUITING

Altamed Dental Clinic

Santa Ana, California, 92704, United States

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Dentistry

Study Record Dates

First Submitted

July 13, 2026

First Posted

July 22, 2026

Study Start

January 15, 2026

Primary Completion

June 26, 2026

Study Completion (Estimated)

June 1, 2028

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations