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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03887039
Collaborator
(none)
78
11

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: clinical examination

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
78 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Oral Findings In A Group of Egyptian Children With Attention Deficit Hyperactivity Disorder: A Cross-Sectional Study
Anticipated Study Start Date :
Aug 1, 2019
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
ADHD group

clinical examination

Other: clinical examination
clinical examination for all the oral findings

normal group

clinical examination

Other: clinical examination
clinical examination for all the oral findings

Outcome Measures

Primary Outcome Measures

  1. oral habits [6 months]

    clinical examination yes/no

Secondary Outcome Measures

  1. DMFT caries index [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

  2. dental trauma [6 months]

    clinical examination yes/no

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sara Gaber Hussien, Principal investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT03887039
Other Study ID Numbers:
  • 14422016496994
First Posted:
Mar 22, 2019
Last Update Posted:
Apr 16, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sara Gaber Hussien, Principal investigator, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 16, 2019