- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05026515
The Influence of Parental Behavior on the Course of the Pediatric Dentistry Session
The Influence of Parental Behavior on the Course of the Pediatric Dentistry : a Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
I will receive the children for consultation at the CHU Saint Pierre - César de Paepe site, to assess the impact of parents' behavior on the child.
First, I will make a first contact with the child in the waiting room using the CORAH scale (self-assessment based on diagrams) which will allow him to assess his temperament in the face of dental care. . Then, I will have the parents / caregiver sign informed consent and authorization to film.
Once the child enters the practice, the video recording will be initiated: the installation on the seat, the confidence building and the care provided will be filmed.
These videos will then be analyzed by several practitioners from different categories (experts in pedodontics, general dentists, dental students, etc.) using the Venham hetero-assessment scale modified for the behavior of the child and of a scale of parental cooperation. These practitioners will be selected via the ADUB (association of dentists of Université Libre de Bruxelles) and some of them could be external to the hospital.
Following this study, the results obtained will be described and statistically analyzed.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brussels, Belgium, 1000
- Tania Vanhée
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- be in the correct age group and agree to participate in the study
Exclusion Criteria:
- not be in the right age group, refuse to participate in the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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4 years and under
Children coming at dental appointment, aged 4 years and under
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To observe the influence of the parents/caregivers behavior on their child during dental treatment
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5 to 6 years
Children coming at dental appointment, aged 5 to 6 years
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To observe the influence of the parents/caregivers behavior on their child during dental treatment
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7 years and over
Children coming at dental appointment, aged 7 years and over
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To observe the influence of the parents/caregivers behavior on their child during dental treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent behavior/Child Behavior
Time Frame: Two weeks
|
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.
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Two weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tania Vanhee, DDS, Université Libre de Bruxelles
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- O.M. 007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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