Preparation Protocol for the First Pediatric Dental Visit

NCT ID: NCT05608720

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-10-01

Brief Summary

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

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).

Conditions

Behavior, Child; Dentist-Patient Relations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

study group

Information Booklet prior to the dental visit

Group Type: EXPERIMENTAL

Information Booklet

Intervention Type: BEHAVIORAL

Information Booklet prior to the dental visit

control group

no information prior to the dental visit

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Information Booklet

Information Booklet prior to the dental visit

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Simone Bagattoni

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone Bagattoni

Role: PRINCIPAL_INVESTIGATOR

Bologna University

Locations

Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile

Bologna, , Italy

Countries

Italy

Other Identifiers

bagattoni1

Identifier Type: -

Identifier Source: org_study_id