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NCT Number: NCT05608720

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

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Key information

Conditions

Behavior, Child Behavior Child Behavior Dentist-Patient Relations

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bologna, 40125, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Information Booklet

Behavioral

Information Booklet prior to the dental visit

Primary outcomes

  1. child's behavior assessed by dentist with the Frankl Behavior Rating Scale (FBRS)

    Time frame: immediately after the intervention

    FBRS: values from 1 (Definitely negative) to 4 (definitely positive)

Secondary outcomes

  1. self reported pain assessed by the Wong Baker faces pain rating scale (WBFPRS)

    Time frame: immediately after the intervention

    WBFPRS: from 0 (no hurt) to 10 (hurts worst)

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

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

Acronym: PREP

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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