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Salivary Bacteria and Oral Health Status in Children With ADHD (ADHD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00966394
First Posted: August 26, 2009
Last Update Posted: May 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose

Attention deficit and hyperactivity (ADHD) affect 6% of school-aged children. Few studies reported higher prevalence of caries and restorations among children with ADHD. Methylphenidate is the drug of choice to treat ADHD. according to the medical literature methylphenidate can cause xerostomia.

Our study will investigate saliva parameters (such as quantity, bacteria in saliva, buffer capacity), oral hygiene and diet habits and their influence on caries among children with ADHD and among healthy children.

Our hypothesis is:

  • Children with ADHD will have more caries.
  • Children with ADHD will have more detrimental oral hygiene and diet habits.
  • There will be a difference in the saliva parameters between children with ADHD and healthy children.

Condition
Attention Deficit Hyperactivity Disorders Caries, Dental Xerostomia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Changes in Salivary Bacteria and Oral Health Status in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Biospecimen Retention:   None Retained
saliva

Estimated Enrollment: 150
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
ADHD medication
Children with ADHD and pharmacologic treatment
ADHD without medication
Children with ADHD without pharmacologic treatment
healthy
Healthy children ASA1

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children with ADHD, treated by medications or not, treated in the neurologic clinic at Hadassah.

The control are healthy children visiting the pediatric dental clinic at Hadassah.

Criteria

Inclusion Criteria:

  • test group- diagnosis of ADHD.
  • control group- ASA1

Exclusion Criteria:

  • control group
  • administration of medicine at the time of the check-up.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966394


Locations
Israel
Hadassah school of dental medicine
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Responsible Party: Dr. Moti Moskovitz, Department of Pediatric Dentistry, Hadassah School of Dental Medicine
ClinicalTrials.gov Identifier: NCT00966394     History of Changes
Other Study ID Numbers: adhd-hmo-ctil
First Submitted: August 25, 2009
First Posted: August 26, 2009
Last Update Posted: May 26, 2010
Last Verified: August 2009

Keywords provided by Hadassah Medical Organization:
ADHD, saliva, caries

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Xerostomia
Dental Caries
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases