Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03887039
Other study ID # 14422016496994
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 2019
Est. completion date July 2020

Study information

Verified date March 2019
Source Cairo University
Contact sara G hussien, BSc
Phone 00201012120090
Email Sara.Gaber@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 78
Est. completion date July 2020
Est. primary completion date June 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
clinical examination
clinical examination for all the oral findings

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary oral habits clinical examination yes/no 6 months
Secondary 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
Secondary dental trauma clinical examination yes/no 6 months
See also
  Status Clinical Trial Phase
Completed NCT04056559 - Normative Assessment of Adaptable Mouthguards. N/A
Not yet recruiting NCT06081868 - RCT on Effectiveness of Oral Health Preventive Programmes in School Children in Uganda N/A
Recruiting NCT05938166 - The Effects of Using Augmented Reality (AR) Simulation System to Train Foreign Care Workers. N/A
Completed NCT04812990 - A Cross Sectional Observational Study on Relation Between Oral Manifestation and Hepatitis C in Egypt
Completed NCT01156376 - Oral Irritation Study of Two Experimental Mouthrinses N/A
Recruiting NCT04706156 - Oral Side Effects of COVID-19 Vaccine
Completed NCT05540171 - An Educational Intervention Program to Improve the Oral Health of HIV-Positive Children in Kano, Nigeria. N/A
Completed NCT01699412 - Clinical Trial With Clobetasol and Dexamethasone for Topical Treatment of Oral Lesions of Chronic Graft-versus-host Disease Phase 3
Completed NCT05549648 - The Oral Biomechanical Functions of Hong Kong Healthy Adults N/A