NCT05608720

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

8 months

First QC Date

October 27, 2022

Last Update Submit

November 2, 2022

Conditions

Behavior, ChildDentist-Patient Relations

Keywords

behavior managementfirst dental visit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    immediately after the intervention

Study Arms (2)

study group

EXPERIMENTAL

Information Booklet prior to the dental visit

Behavioral: Information Booklet

control group

NO INTERVENTION

no information prior to the dental visit

Interventions

Information BookletBEHAVIORAL

Information Booklet prior to the dental visit

study group

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • child requiring a first dental visit

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bologna, 40125, Italy

Location

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Simone Bagattoni

    Bologna University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 27, 2022

First Posted

November 8, 2022

Study Start

January 1, 2019

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)