- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03887039
Oral Findings In A Group of Egyptian Children With Attention Deficit Hyperactivity Disorder
Oral Findings In A Group of Egyptian Children With Attention Deficit Hyperactivity Disorder: A Cross-Sectional Study
Attention-deficit/hyperactivity disorder is the most common childhood neuro-developmental disorder that is characterized by inattention, hyperactivity, and impulsivity. These symptoms last till adulthood in 65% of cases. ADHD has been reported to have a worldwide prevalence of 5.3% and it is more common in boys than in girls (Ghanizadeh 2008; Serra-Negra et al. 2012 and Shooshtari et al. 2013) The symptoms of ADHD are generally treated through behavioral therapy, with or without pharmacological intervention. Medications prescribed are commonly divided into stimulant or non-stimulant drugs. The stimulant medications (such as methylphenidate and amphetamines) have been implicated in adverse oral effects, such as xerostomia and gingival enlargement. The current evidence is controversial regarding the severity and prevalence of dental caries, dental trauma, periodontal diseases, oral habits and tooth wear among patients with ADHD (Chau et al. 2017).
In the Arab world, few studies have been published on ADHD. Accordingly, in the Arab society and Egypt there are limited data regarding the oral findings of children with ADHD. Owing to the sparsity of these data, this study will be conducted to evaluate different oral characteristics of Egyptian children with ADHD.
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients referred from Abu El-Reesh and El-Demerdash children hospitals, diagnosed with ADHD.
Control group: A matched group of patients attending at Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.
Patients will be included in the study according to the eligibility criteria.
Description
Inclusion Criteria:
- - Egyptian children 3-6 years old diagnosed with ADHD.
- Patients taking medications for the treatment of ADHD or not.
- Both male and female patients will be included.
Control Group:
A matched group of healthy children aged 3-6 years old.
Exclusion Criteria:
- - Non-Egyptian children.
- Patients having systemic disorders, such as cerebral palsy or Down's syndrome.
- Patients complaining from any systemic disease
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ADHD group
clinical examination
|
clinical examination for all the oral findings
|
|
normal group
clinical examination
|
clinical examination for all the oral findings
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
oral habits
Time Frame: 6 months
|
clinical examination yes/no
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DMFT caries index
Time Frame: 6 months
|
DMFT D=dacayed M=missed due to caries F=filled T=tooth score 0-20 for primary teeth0 is the best / 20 is the worst
|
6 months
|
|
dental trauma
Time Frame: 6 months
|
clinical examination yes/no
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara G Hussien, BSc, Resident at pediatric Dentistry and Dental Public Health Department
- Study Director: Randa Y Abdel Gawad, PhD, Associate Professor at Pediatric Dentistry and Dental Public Health Department
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14422016496994
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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