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Cerebral PalsyNCT05650593

Oral Health Status in a Group of Egyptian Children With Cerebral Palsy: A Cross-sectional Study

An observational study of Cerebral Palsy, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the study is to assess the oral health status in a group of Egyptian children with cerebral palsy. Read more about this study

Who is it for?
Ages 4 to 14 years
Conditions the study is for
Cerebral Palsy
How many people
500 participants
Where
1 siteEgypt
Study dates
6 Oct 2022to 1 May 2023
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 4 to 14 years
  • All sexes
  • Child

Study population: Egyptian children with cerebral palsy

Who may be able to join

  • Children diagnosed with Cerebral Palsy
  • Children aged from 4 to 14years old irrespective of sex.

Who cannot join

  • The child is uncooperative.
  • Parents that refused to give informed consent

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • The National institute of Neuromotor System in Imbaba, Cairo, Egypt.

    Cairo, 02

    Recruiting

Other trials in Egypt

About this study

The aim of the study is to assess the oral health status in a group of Egyptian children with cerebral palsy.

Read the detailed description

Cerebral palsy (CP) is a group of neuromuscular disorders affecting the development of movement and posture, causing activity limitations. Disturbances to the development of the infant brain may occur early either in utero, during birth or in the first few months of infancy.It may be due to infection, trauma, hypoxia, or hyperbilirubinemia in addition to genetic and biochemical factors. Subsequently, there will be limitations in muscular activity. CP is the most common motor disability occurring during childhood. The prevalence of CP around the world ranges from 1.5 to >4/1000 live births in the developed countries (Al Hashmi et al. 2017).

The CP classification includes four types: spastic, dyskinetic, hypotonic, and mixed, the spastic type being the most common and at times most severe one. Manifestations of cerebral palsy can take on a vast spectrum from minimal symptoms such as minor movement limitation to spasms, muscular rigidity, confinement in a wheelchair, poor bowel control and respiratory problems (Răducanu, Anca et al. 2008).

The patients with cerebral dysfunction may also display mental retardation, epilepsy, sensorial deficiencies (sight and hearing impairment), persistent primitive reflexes, attention-, memory-, learningand emotional problems, language and speaking disturbances (Amit Mani et al. 2015) .

Patients with CP have numerous oral health problems. Neuromuscular disturbances can affect oral health significantly; they may result in changes of the orofacial region's structure and may affect the development of parafunctional habits, including feeding problems, difficulty maintaining oral hygiene (OH), and barriers to oral care access. Malocclusions and tooth wear are common. Experience of dental trauma is also highly prevalent due to instability as a result of neuromuscular defects or seizures (Du et al. 2010).

Children with CP display the same oral pathology as healthy persons. However, they present a higher susceptibility to several oro-dental diseases (dental caries, periodontal disease, dental trauma, malocclusion, bruxism, temporomandibular joint disorders, enamel hypoplasia, abnormal oral habits - tongue thrust, mouth breathing, drooling etc.) due to the abnormal neuromuscular coordination of the tongue, lips, and cheeks and to the low level and the reduced quality of the oral care. The treatment of CP is complex and multidisciplinary, consisting in general (kinetotherapy, surgical interventions, myorelaxants medication) and oral treatment (behavior management, prophylactic, curative) (Sedky 2017).

Parental counselling about diet, oral hygiene procedures and the use of fluorides are preferred to begin as early as possible. Local anaesthesia is not contraindicated; nevertheless sedation is useful to reduce nausea and lingual dystonia, anxiolytic and muscle relaxant drugs such as diazepam are useful as premedication. In some patients, because of uncontrollable movements or poor cooperation, dental treatment has to be carried out under general anaesthesia. Regarding patient access to dental chair, some patients can be treated in their wheelchairs. Preoperative mouthwashes are prevented better administered as a gel or spray) .use of rubber dam and powerful aspiration are needed. The dental chair should be moved slowly to prevent spastic muscle responses (Wasnik et al. 2020).

Also, the oral manifestations of cp are well documented in literature, there have been few studies that actually investigated the prevelance of oral manifestations in cp patients. Thus the aim of the current proposal is to study the prevelance of oral manifestation of cp. (Du et al. 2010).

Conditions
Cerebral Palsy
Keywords
oral health
Medical subject headings
Cerebral Palsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oral manifestations of cerebral palsy patients

    assess the oral health status in a group of Egyptian children with cerebral palsy.

    assess the oral health status in a group of Egyptian children with cerebral palsy.

    assess the oral health status in a group of Egyptian children with cerebral palsy.

    assess the oral health status in a group of Egyptian children with cerebral palsy.

    assess the oral health status in a group of Egyptian children with cerebral palsy.

    assess the oral health status in a group of Egyptian children with cerebral palsy.

    assess the oral health status in a group of Egyptian children with cerebral palsy.

    asses Oral manifestations in cerebral palsy patients

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2022
  2. Study start6 Oct 2022
  3. Primary completion6 Dec 2022 (estimated)
  4. Study completion1 May 2023 (estimated)

Resources

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
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05650593
Sponsor's protocol ID
oral health in cp patients
Status last verified
Dec 2022
First submitted
6 Dec 2022
Last updated
14 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bensi C, Costacurta M, Docimo R. Oral health in children with cerebral palsy: A systematic review and meta-analysis. Spec Care Dentist. 2020 Sep;40(5):401-411. doi: 10.1111/scd.12506. Epub 2020 Aug 20.

    PubMed 32815638
  • Al-Allaq T, DeBord TK, Liu H, Wang Y, Messadi DV. Oral health status of individuals with cerebral palsy at a nationally recognized rehabilitation center. Spec Care Dentist. 2015 Jan-Feb;35(1):15-21. doi: 10.1111/scd.12071. Epub 2014 Apr 7.

    PubMed 24708141

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy, run by Cairo University at 1 site in Egypt.

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 2 inclusion and 2 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 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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 s h khairy, baceloria (01090615775 ext. 01090615775, sara.khairy@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 manifestations of cerebral palsy patients (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05650593, which also lists 2 linked publications.

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 14 Dec 2022.

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