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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01106768
First received: April 9, 2010
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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.


Condition
Attention Deficit Disorder With Hyperactivity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Oral Needs of Children With Disorder Attention Deficit/Hyperactivity Disorder

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of anxiety through the CFSS-DS scale (Dental subscale of Children's Fear Survey Schedule, Schedule 1) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: May 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/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

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

children with attention deficit disorder with or without hyperactivity

Criteria

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106768

Contacts
Contact: MANIERE Marie-Cécile, MD 33390243887 Maniere.Marie-Cecile@chru-strasbourg.fr

Locations
France
CHRU ,Hopital Civil, Département d'Odontologie Pédiatrique Service de Consultations et de Traitements Dentaires Recruiting
Strasbourg, France, 67091
Contact: MANIERE Marie-Cécile, MD    33390243887    Maniere.Marie-Cecile@chru-strasbourg.fr   
Contact: GARRET Annelyse, MD    3390243887    annelyse.garret-bernardin@chru-strasbourg.fr   
Sub-Investigator: FINCK Sonja, MD         
Sub-Investigator: DE SAINT-MARTIN Anne, MD         
Sub-Investigator: GARRET AnneLyse, MD         
Sub-Investigator: BACON William, MD         
Sub-Investigator: GRAS-VINCENDON Agnès, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: MANIERE Marie-Cécile, MD not affiliated
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01106768     History of Changes
Other Study ID Numbers: 2008-A00616-49
Study First Received: April 9, 2010
Last Updated: June 28, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
oral health needs
children
attention deficit disorder with or without hyperactivity

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014