NCT05026515

Brief Summary

The aim of the experiment is to analyze the impact of the behavior of the accompanying parent on the behavior of the child during a first dental session according to the age group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

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

December 13, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

Same day

First QC Date

April 24, 2021

Last Update Submit

August 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Parent behavior/Child Behavior

    By hetero-evaluation scale, 20 dentists will estimate the behavior of parents and children. The measurements via the observation of filmed sessions were carried out thanks to two views.

    Two weeks

Study Arms (3)

4 years and under

Children coming at dental appointment, aged 4 years and under

Behavioral: Parents

5 to 6 years

Children coming at dental appointment, aged 5 to 6 years

Behavioral: Parents

7 years and over

Children coming at dental appointment, aged 7 years and over

Behavioral: Parents

Interventions

ParentsBEHAVIORAL

To observe the influence of the parents/caregivers behavior on their child during dental treatment

4 years and under5 to 6 years7 years and over

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

60 patients presenting for the first time to the pediatric dentistry consultation at the CHU Saint-Pierre - César de Paepe site were selected for this study between. 3 groups of 20 children, respectively aged 4 and under, 5 to 6 years old and over 7 years old, were formed.67 children participated in this study. They were divided into 3 groups according to their age (4 years and under, 5 to 6 years and 7 years and over). During the search, 7 patients were excluded: due to the image rights not granted. The data were collected and analyzed by 2 observers. Then a randomization took place thus creating a sample of 15 children divided into 3 same groups. The data were collected and analyzed by 20 practitioner observers

You may qualify if:

  • be in the correct age group and agree to participate in the study

You may not qualify if:

  • not be in the right age group, refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tania Vanhée

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Child Behavior

Interventions

Single Parent

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Single PersonMarital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Officials

  • Tania Vanhee, DDS

    Université Libre de Bruxelles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Dentist

Study Record Dates

First Submitted

April 24, 2021

First Posted

August 30, 2021

Study Start

December 13, 2020

Primary Completion

December 13, 2020

Study Completion

March 2, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations