Oral ManifestationsNCT03887039
Oral Findings In A Group of Egyptian Children With Attention Deficit Hyperactivity Disorder
An observational study of Oral Manifestations, run by Cairo University.
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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Manifestations
- What is being tested?
- clinical examination
- Type of treatment
- Pill or oral medicine
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- 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.
Who may be able to join
- - 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.
Who cannot join
- - Non-Egyptian children.
- Patients having systemic disorders, such as cerebral palsy or Down's syndrome.
- Patients complaining from any systemic disease
Trial locations and contacts
No sites are listed yet.
Randa Yo Abdel Gawad, PhD contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Oral Manifestations
- Being tested
- clinical examination
- Keywords
- oral findings, oral characteristics, oral health, caries, oral habits, dental trauma, ADHD, children
- Medical subject headings
- Oral Manifestations, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical examinationOther
clinical examination for all the oral findings
| Study group | Role | What they receive |
|---|---|---|
| ADHD group | clinical examination Receives: Other: clinical examination | |
| normal group | clinical examination Receives: Other: clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral habits
clinical examination yes/no
Measured: 6 months
Secondary outcomes (2)
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
Measured: 6 months
dental trauma
clinical examination yes/no
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study startAug 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral ManifestationsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Gaber Hussien, Cairo University
- Investigators
- Sara G Hussien, BSc, Principal investigator, Resident at pediatric Dentistry and Dental Public Health DepartmentRanda Y Abdel Gawad, PhD, Study director, Associate professor at pediatric Dentistry and Dental Public Health Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887039
- Sponsor's protocol ID
- 14422016496994
- Status last verified
- Mar 2019
- First submitted
- 19 Mar 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Findings In A Group of Egyptian Children With Attention Deficit Hyperactivity Disorder: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT03887039
- Acronym / sponsor ID
- 14422016496994
- Conditions
- Oral Manifestations
- Keywords
- oral findings, oral characteristics, oral health, caries, oral habits, dental trauma, ADHD, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD group | – | Other: clinical examinationclinical examination |
| normal group | – | Other: clinical examinationclinical examination |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- - 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.
- A matched group of healthy children aged 3-6 years old.
Key exclusion criteria (3 listed)
- - Non-Egyptian children.
- Patients having systemic disorders, such as cerebral palsy or Down's syndrome.
- Patients complaining from any systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical examinationclinical examination for all the oral findings | Other | ADHD group, normal group |
Primary outcome
oral habits
Time frame: 6 months
clinical examination yes/no
2 secondary outcomes
DMFT caries index
Time frame: 6 months
dental trauma
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randa Yo Abdel Gawad, PhD contact
Sara G Hussien, BSc principal investigator
Resident at pediatric Dentistry and Dental Public Health Department
Randa Y Abdel Gawad, PhD study director
Associate professor at pediatric Dentistry and Dental Public Health Department
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Manifestations, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sara G hussien, BSc (00201012120090, Sara.Gaber@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral habits (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.