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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • CHRU ,Hopital Civil, Département d'Odontologie Pédiatrique Service de Consultations et de Traitements Dentaires
        • Contact:
        • Contact:
        • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Strasbourg, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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