Attention Deficit Hyperactivity DisordersADHDNCT00966394
Salivary Bacteria and Oral Health Status in Children With ADHD
An observational study of Attention Deficit Hyperactivity Disorders and Caries, Dental, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorders, Caries, Dental, Xerostomia
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2009to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- test group- diagnosis of ADHD.
- control group- ASA1
Who cannot join
- control group
- administration of medicine at the time of the check-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Salivary Bacteria and Oral Health Status in Children With Attention Deficit Hyperactivity Disorder (ADHD)
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.
Read more
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.
- Keywords
- ADHD, saliva, caries
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Dental Caries, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ADHD medication | Children with ADHD and pharmacologic treatment | |
| ADHD without medication | Children with ADHD without pharmacologic treatment | |
| healthy | Healthy children ASA1 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisordersStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966394
- Sponsor's protocol ID
- adhd-hmo-ctil
- Acronym
- ADHD
- Status last verified
- Aug 2009
- First submitted
- 25 Aug 2009
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Salivary Bacteria and Oral Health Status in Children With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00966394
- Acronym / sponsor ID
- ADHD / adhd-hmo-ctil
- Keywords
- ADHD, saliva, caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 26 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ADHD medication | – | –Children with ADHD and pharmacologic treatment |
| ADHD without medication | – | –Children with ADHD without pharmacologic treatment |
| healthy | – | –Healthy children ASA1 |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- test group- diagnosis of ADHD.
- control group- ASA1
Key exclusion criteria (2 listed)
- control group
- administration of medicine at the time of the check-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorders and Caries, Dental, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2010; AzTrials last refreshed its copy on 8 Nov 2026.