Oral Findings In A Group of Egyptian Children With Attention Deficit Hyperactivity Disorder

NCT03887039 | Unknown

• 1 other identifier: 14422016496994
• Study Type: observational
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oral Manifestations

Keywords

oral findings; oral characteristics; oral health; caries; oral habits; dental trauma; ADHD; children

Outcome Measures

Primary Outcomes (1)

• oral habits

  clinical examination yes/no

  6 months

Secondary Outcomes (2)

• DMFT caries index

  6 months

• dental trauma

  6 months

Study Arms (2)

ADHD group

clinical examination

Other: clinical examination

normal group

clinical examination

Other: clinical examination

Interventions

clinical examination OTHER

clinical examination for all the oral findings

ADHD group; normal group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• \- Non-Egyptian children.
• Patients having systemic disorders, such as cerebral palsy or Down's syndrome.
• Patients complaining from any systemic disease

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Oral Manifestations; Attention Deficit Disorder with Hyperactivity

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Sara G Hussien, BSc

  Resident at pediatric Dentistry and Dental Public Health Department

  PRINCIPAL INVESTIGATOR

• Randa Y Abdel Gawad, PhD

  Associate professor at pediatric Dentistry and Dental Public Health Department

  STUDY DIRECTOR

Central Study Contacts

sara G hussien, BSc

CONTACT

00201012120090; Sara.Gaber@dentistry.cu.edu.eg

Randa Yo Abdel Gawad, PhD

CONTACT

00201222272010

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 22, 2019
• Study Start: August 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 16, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share