Oral Findings In A Group of Egyptian Children With Attent... | NCT03887039

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

NCT03887039

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Apr 16, 2019Actual

Enrollment

78Estimated

Phase

Not provided

Conditions

Oral Manifestations

Interventions

clinical examination

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2019Estimated

Primary Completion Date

Jun 2020Estimated

Completion Date

Jul 2020Estimated

First Submitted Date

Mar 19, 2019

First Submission Date that Met QC Criteria

Mar 21, 2019

First Posted Date

Mar 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2019

Last Update Posted Date

Apr 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

78Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ADHD group		clinical examination	Other: clinical examination
normal group		clinical examination	Other: clinical examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
clinical examination	Other	clinical examination for all the oral findings	ADHD group normal group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
oral habits	clinical examination yes/no	6 months

Secondary Outcomes

Measure	Description	Time Frame
DMFT caries index	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	clinical examination yes/no

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

6 Years

Standard Ages

Child

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
sara G hussien, BSc	Contact	00201012120090		Sara.Gaber@dentistry.cu.edu.eg
Randa Yo Abdel Gawad, PhD	Contact	00201222272010

Overall Officials

Name	Affiliation	Role
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

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009912	Oral Manifestations
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012149	Restraint, Physical

Ancestor Terms

ID	Term
D032763	Behavior Control
D013812	Therapeutics
D007103	Immobilization
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided