NCT06058533

Brief Summary

The purpose of this study is to determine whether pre-visit positive imagery has an impact in decreasing dental anxiety and fear in pediatric patients as well as increasing patient cooperation during treatment visits. Patients needing at least 1 composite filling with nitrous and local anesthetic will receive a picture book if they are selected in the experimental group, and no picture book if they are in the control group. Patients will be asked to be fill out a pre-operative survey and post-operative survey asking how they feel about treatment. Parents will also be asked to fill out a post-operative survey.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

1.7 years

First QC Date

September 15, 2023

Last Update Submit

July 10, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Dental Anxiety

    Patients will also be asked to fill out a pre- and post-survey that allows them to express their level of dental fear and anxiety before and after the appointment using the Venham Picture Test. The total time commitment will be about 20 minutes and will be a part of their normal dental visit, no additional time is needed.

    1 day (1 hour during their dental visit)

  • Patient Behavior

    Parents/caregivers will also be given a post-operative survey asking whether they felt the pre-visit positive imagery helped improve patient's behavior.

    1 day (1 hour during their dental visit)

Study Arms (2)

Control Group

NO INTERVENTION

No intervention will be given to this group. Each treatment visit will move forward as routine.

Previsit Imagery Group

EXPERIMENTAL

This group will be given previsit imagery (picture book) before treatment visit.

Other: Previsit Imagery Picturebook

Interventions

This picturebook will include pictures of the dental operatory and materials the patient can expect to see during their dental treatment appointment. The pictures included will be generalized pictures of a dental operatory and dental materials. The picture book will also include some words to describe what is happening during the appointment. It is important to note that pictures of the local anesthetic / needle will not be shown in the picture book but will be used during the appointment. The procedures described are standard protocol at both clinics. The traditional picture book shown will be a hard copy.

Previsit Imagery Group

Eligibility Criteria

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

You may qualify if:

  • Patients that are healthy with no systemic conditions and are considered ASA I or ASA II
  • Patients who have never had any form of dental treatment before.
  • Patients who need at least 1 filling to be restored with composite due to caries and will need local anesthetic and nitrous oxide inhalation.
  • English speaking patients

You may not qualify if:

  • Patients with a visual impairment
  • Patients with developmental delays that are unable to read or interpret pictures for their age-level.
  • Patients whose treatment changes to something other than composite
  • Patients who refuse to wear nitrous hood.
  • Patients who are unable to read and comprehend English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herman Ostrow School of Dentistry of USC

Los Angeles, California, 90089, United States

Location

Study Officials

  • Arusha Bhatia

    Herman Ostrow School of Dentistry of USC

    PRINCIPAL INVESTIGATOR

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
Assistant Professor of Clinical Dentistry

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 28, 2023

Study Start

October 15, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations