Attention Deficit Disorder With HyperactivityNCT00328224
Oral Status and Prevalence of Dental Trauma in Children Treated With Ritalin Due to Attention-Deficit Hyperactivity Disorder (ADHD)
An observational study of Attention Deficit Disorder With Hyperactivity and Dental Caries, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
To evaluate the dental status of children using ritalin and suffering from ADHA in comparison to healthy children. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Dental Caries, Dental Occlusion, Traumatic
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- May 2006to Oct 2007
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: healthy children children with adhd treated with ritalin
Who may be able to join
- children ages 5-12 years healthy children children taking ritalin who suffer from ADHD
Who cannot join
- all others
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the dental status of children using ritalin and suffering from ADHA in comparison to healthy children.
Read the detailed description
In this trial oral and dental status of 30 children (ages 5-12) who suffer from ADHD and treated with ritalin will be evaluated. Parameters that will be checked are the following: DMFT - decay, missing, filling teeth for dental status, GI - gingival index, PI - plaque index for periodontal status. OJ - over jet and OB - over bite for inter-maxillary relations and susceptibility for dental trauma. In addition these parameters will be collected for 30 age and sex match healthy children.
- Keywords
- ritalin, ADHA, dental status, periodontal status, Attention-Deficit Hyperactivity Disorder, Dental trauma
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Dental Caries, Dental Occlusion, Traumatic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startMay 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies 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
- Case-control
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Diana Ram, DMD, Principal investigator, Hadassah Medical OrganizationMeir Redlich, DMD,PhD, Study director, Hadassah Medical OrganizationHadas Katz-Sagi, DMD, Study director, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328224
- Sponsor's protocol ID
- 230606-HMO-CTIL
- Status last verified
- May 2006
- First submitted
- 18 May 2006
- Last updated
- 1 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Status and Prevalence of Dental Trauma in Children Treated With Ritalin Due to Attention-Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00328224
- Acronym / sponsor ID
- 230606-HMO-CTIL
- Keywords
- ritalin, ADHA, dental status, periodontal status, Attention-Deficit Hyperactivity Disorder, Dental trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Oct 2007 (actual)
- First posted
- 19 May 2006 (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.
To evaluate the dental status of children using ritalin and suffering from ADHA in comparison to healthy children.
Detailed description
In this trial oral and dental status of 30 children (ages 5-12) who suffer from ADHD and treated with ritalin will be evaluated. Parameters that will be checked are the following: DMFT - decay, missing, filling teeth for dental status, GI - gingival index, PI - plaque index for periodontal status. OJ - over jet and OB - over bite for inter-maxillary relations and susceptibility for dental trauma. In addition these parameters will be collected for 30 age and sex match healthy children.
Study design
- Observational model
- Case-control
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- healthy children children with adhd treated with ritalin
Key inclusion criteria (1 listed)
- children ages 5-12 years healthy children children taking ritalin who suffer from ADHD
Key exclusion criteria (1 listed)
- all others
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 1 Nov 2007.
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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.
Diana Ram, DMD principal investigator
Hadassah Medical Organization
Meir Redlich, DMD,PhD study director
Hadassah Medical Organization
Hadas Katz-Sagi, DMD study director
Hadassah Medical Organization
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 Disorder With Hyperactivity and Dental Caries, 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 1 inclusion and 1 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 1 Nov 2007. 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 1 Nov 2007.