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

April 13, 2019 updated by: Sara Gaber Hussien, Cairo University

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

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2019

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (Actual)

March 22, 2019

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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