- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01106768
Evaluation of Oral Needs of Children With Disorder Attention Deficit/Hyperactivity Disorder
June 28, 2012 updated by: University Hospital, Strasbourg, France
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.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: MANIERE Marie-Cécile, MD
- Phone Number: 33390243887
- Email: Maniere.Marie-Cecile@chru-strasbourg.fr
Study Locations
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-
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Strasbourg, France, 67091
- Recruiting
- CHRU ,Hopital Civil, Département d'Odontologie Pédiatrique Service de Consultations et de Traitements Dentaires
-
Contact:
- MANIERE Marie-Cécile, MD
- Phone Number: 33390243887
- Email: Maniere.Marie-Cecile@chru-strasbourg.fr
-
Contact:
- GARRET Annelyse, MD
- Phone Number: 3390243887
- Email: annelyse.garret-bernardin@chru-strasbourg.fr
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Sub-Investigator:
- FINCK Sonja, MD
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Sub-Investigator:
- DE SAINT-MARTIN Anne, MD
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Sub-Investigator:
- GARRET AnneLyse, MD
-
Sub-Investigator:
- BACON William, MD
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Sub-Investigator:
- GRAS-VINCENDON Agnès, MD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 15 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
children with attention deficit disorder with or without hyperactivity
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measurement of anxiety through the CFSS-DS scale (Dental subscale of Children's Fear Survey Schedule, Schedule 1)
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: MANIERE Marie-Cécile, MD, Not Affiliated
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Anticipated)
April 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
April 9, 2010
First Submitted That Met QC Criteria
April 19, 2010
First Posted (Estimate)
April 20, 2010
Study Record Updates
Last Update Posted (Estimate)
July 2, 2012
Last Update Submitted That Met QC Criteria
June 28, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-A00616-49
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Attention Deficit Disorder With Hyperactivity
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Ornit CohenUnknownAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersIsrael
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Cingulate TherapeuticsRecruitingPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
-
Karolinska InstitutetCompletedAttention Deficit Disorder With Hyperactivity (ADHD)Sweden
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Fondation LenvalCompletedAttention Deficit Disorder With Hyperactivity | Attention Deficit Disorder Without HyperactivityFrance
-
Clinical and Translational Genome Research Institute...Children's Specialized HospitalTerminatedAttention Deficit Disorders With HyperactivityUnited States
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Rabin Medical CenterNG Solutions LtdRecruitingADHD - Attention Deficit Disorder With HyperactivityIsrael
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University of PennsylvaniaCompletedAttention Deficit Disorder With Hyperactivity (ADHD)United States
-
Nemours Children's ClinicCompletedAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit DisorderUnited States
-
Massachusetts General HospitalRecruitingAttention Deficit Disorder With Hyperactivity | Attention Deficit DisorderUnited States
-
New River PharmaceuticalsShireCompletedAttention Deficit Hyperactivity Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersUnited States