Clinical trial NCT03887039: Oral Findings In A Group of Egyptian Children With Attention Deficit Hyperactivity Disorder
Official title: Oral Findings In A Group of Egyptian Children With Attention Deficit Hyperactivity Disorder: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Manifestations
Keywords: oral findings
oral characteristics
oral health
caries
oral habits
dental trauma
ADHD
children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 78
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief summary: 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.

Detailed description: Due to lack of published studies about the oral findings of Egyptian Children with ADHD, this study will be conducted to cover this point.

Eligibility criteria: 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

Primary outcomes:
measure: oral habits
timeFrame: 6 months
Secondary outcomes:
measure: DMFT caries index
timeFrame: 6 months
measure: dental trauma
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Resident at pediatric Dentistry and Dental Public Health Department
name: Sara G Hussien, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate professor at pediatric Dentistry and Dental Public Health Department
name: Randa Y Abdel Gawad, PhD
role: STUDY_DIRECTOR
References: