CClinicalTrials.gg
Status unknownNCT01106768Updated Jul 2, 2012

Evaluation of Oral Needs of Children With Disorder Attention Deficit/Hyperactivity Disorder

An observational study in Attention Deficit Disorder With Hyperactivity, sponsored by University Hospital, Strasbourg, France. Status unknown at 1 site in France. Open to participants aged 5 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-02.

Sponsored by University Hospital, Strasbourg, France · Observational

The sponsor has not verified this record recently (last verified Jun 2012), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
140
Ages
5 Years to 15 Years
Sex
All
01

Study summary

There is little accurate data in the literature at present on oral problems of hyperactive children, especially regarding care needs that would justify an assumption oral specific. The purpose of this study is therefore to have accurate data regarding the risk of caries, other oral diseases like periodontal disease, trauma, and assess the needs dental care and problems in cooperation for dental care in a population of children and adolescents with hyperactivity disorder with attention deficit. Finally, it has recently been described as the sleep disordered breathing was not uncommon in disorder attention deficit/hyperactivity disorder, whether snoring and/or apnea. But it is now accepted that some features of facial morphology favoring pharyngeal congestion occur in individuals with obstructive sleep apnea (hyperdivergent typology with increased anterior facial height and decreased posterior facial height, becoming the facial retrognathia, pharyngeal congestion, elongation and thickening of the soft palate, low position of the hyoid bone). A cephalometric analysis of craniofacial architecture and relationships with the soft tissue surrounding skeletal structures will detect if any of these specific characteristics that could promote sleep disordered breathing are found in disorder attention deficit/hyperactivity disorder prevalence with a particular.

02

Conditions studied

  • Attention Deficit Disorder With Hyperactivity

Keywords

  • oral health needs
  • children
  • attention deficit disorder with or without hyperactivity
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's planned enrollment of 140 is close to the median of 134 across 122 observational studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

children with attention deficit disorder with or without hyperactivity

Inclusion criteria

  • Consent signed by parents before the examination
  • With of a social security scheme
  • Age greater than or equal to 5 years and less than 15 years, Children with a diagnosis of attention deficit / hyperactivity confirmed or made by a physician specialists co-investigators of the study, diagnosis defined according to precise criteria for a disorder attention deficit/hyperactivity disorder as specified in DSM-IV with a normal IQ, ie higher than 80, and without other neurological or psychiatric
  • Child consultant in a hospital or doctors' offices

Exclusion criteria

Exclusion Criteria:

  • Refusal of consent of the parents
  • No affiliation to a social security scheme
  • Age below 5 years or more than 15 years
  • Diagnosis of a disorder attention deficit/hyperactivity disorder not confirmed by a physician , IQ \<80, Pathology associated neurological or psychiatric
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
140 participants (estimated)

Groups and cohorts

  • test cohort

    Evaluation of oral health needs of children with attention deficit disorder with or without hyperactivity

  • not disorder cohort

    children without attention deficit disorder

06

What researchers measure

Primary outcomes

  1. Cod and CAOD index for caries,PI and GI indices for periodontal disease, dysfunction and malocclusion classification by WHO and Analysis cephalometric

    Time frame: 18 months

Secondary outcomes

  1. Measurement of anxiety through the CFSS-DS scale (Dental subscale of Children's Fear Survey Schedule, Schedule 1)

    Time frame: 18 months

07

Study locations

1 of 1 sites recruiting
  • CHRU ,Hopital Civil, Département d'Odontologie Pédiatrique Service de Consultations et de Traitements Dentaires
    Strasbourg, 67091, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01106768
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Apr 20, 2010
Start date
May 2009
Primary completion
Apr 2013 (estimated)
Completion
Dec 2013 (estimated)
Last update
Jul 2, 2012

Study contacts

MANIERE Marie-Cécile, MD
Contact
Maniere.Marie-Cecile@chru-strasbourg.fr
33390243887
MANIERE Marie-Cécile, MD
principal investigator · not affiliated

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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