NCT00966394

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 26, 2010

Status Verified

August 1, 2009

Enrollment Period

6 months

First QC Date

August 25, 2009

Last Update Submit

May 25, 2010

Conditions

Attention Deficit Hyperactivity DisordersCaries, DentalXerostomia

Keywords

ADHD, saliva, caries

Study Arms (3)

ADHD medication

Children with ADHD and pharmacologic treatment

ADHD without medication

Children with ADHD without pharmacologic treatment

healthy

Healthy children ASA1

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • control group
  • administration of medicine at the time of the check-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah school of dental medicine

Jerusalem, 91120, Israel

Location

Biospecimen

Retention: NONE RETAINED

saliva

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityDental CariesXerostomia

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersTooth DemineralizationTooth DiseasesStomatognathic DiseasesSalivary Gland DiseasesMouth Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 26, 2009

Study Start

November 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 26, 2010

Record last verified: 2009-08

Locations

IL(1)