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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01106768
Other study ID # 2008-A00616-49
Secondary ID
Status Recruiting
Phase N/A
First received April 9, 2010
Last updated June 28, 2012
Start date May 2009
Est. completion date December 2013

Study information

Verified date June 2012
Source University Hospital, Strasbourg, France
Contact MANIERE Marie-Cécile, MD
Phone 33390243887
Email Maniere.Marie-Cecile@chru-strasbourg.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date December 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 15 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU ,Hopital Civil, Département d'Odontologie Pédiatrique Service de Consultations et de Traitements Dentaires Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cod and CAOD index for caries,PI and GI indices for periodontal disease, dysfunction and malocclusion classification by WHO and Analysis cephalometric 18 months No
Secondary Measurement of anxiety through the CFSS-DS scale (Dental subscale of Children's Fear Survey Schedule, Schedule 1) 18 months No
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