Preparation Protocol for the First Pediatric Dental Visit (PREP)

Randomized Clinical Trial to Test a Preparation Protocol for the First Pediatric Dental Visit.

To date, not enough attention has been paid to the role of communication before the first dental visit to encourage the child's cooperation and avoid dysfunctional behaviors. The dentist can provide parents with the information they need to adequately prepare the child for treatment. The present study aims to investigate the effectiveness of an infor-mation booklet to promote pediatric patients' cooperation during the first dental visit

Study Overview

• Status: Completed
• Conditions: Behavior, Child; Dentist-Patient Relations
• Intervention / Treatment: Behavioral: Information Booklet

Detailed Description

The aim of the study was to test an Information Booklet preparing the child to the first dental vis-it. Forty-five children and one parent per included child took part in the trial. Children were ran-domized in two groups: the Information Booklet was e-mailed to the parents of the study group. At the end of the visit, the dentist and the parent evaluated the child's behavior through the Frankl Behavior Rating Scale (FBRS) and the utility of the Booklet through a Likert scale. The children evaluated the pleasantness of the visit and the perceived pain through the Wong-Baker FACES® Pain Rating Scale (WBFPRS).

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40125
    • Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• child requiring a first dental visit

Exclusion Criteria:

• previous dental visits, intellectual disability, mother tongue other than Italian, una-vailable e-mail address

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; Information Booklet prior to the dental visit	Behavioral: Information Booklet; Information Booklet prior to the dental visit
No Intervention: control group; no information prior to the dental visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
child's behavior assessed by dentist with the Frankl Behavior Rating Scale (FBRS)	FBRS: values from 1 (Definitely negative) to 4 (definitely positive)	immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
self reported pain assessed by the Wong Baker faces pain rating scale (WBFPRS)	WBFPRS: from 0 (no hurt) to 10 (hurts worst)	immediately after the intervention

Collaborators and Investigators

• Sponsor: University of Bologna
• Investigators: Principal Investigator: Simone Bagattoni, Bologna University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: behavior management; first dental visit
• Other Study ID Numbers: bagattoni1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No