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.
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
- Recruiting
The National institute of Neuromotor System in Imbaba, Cairo, Egypt.
Cairo, 02
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.
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.
- First posted14 Dec 2022
- Study start6 Oct 2022
- Primary completion6 Dec 2022 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Khairy Mahmoud, Cairo University
- Investigators
- cairo university, Principal investigator, Cairo University
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 32815638Al-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
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Status in a Group of Egyptian Children With Cerebral Palsy: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05650593
- Acronym / sponsor ID
- oral health in cp patients
- Conditions
- Cerebral Palsy
- Keywords
- oral health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 6 Dec 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 14 Dec 2022 (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.
The aim of the study is to assess the oral health status in a group of Egyptian children with cerebral palsy.
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).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- Egyptian children with cerebral palsy
Key inclusion criteria (2 listed)
- Children diagnosed with Cerebral Palsy
- Children aged from 4 to 14years old irrespective of sex.
Key exclusion criteria (2 listed)
- The child is uncooperative.
- Parents that refused to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oral manifestations of cerebral palsy patients
Time frame: baseline
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Background: PubMed 32815638Bensi 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.
- Background: PubMed 24708141Al-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.
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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.
cairo university principal investigator
Cairo University
1 site in 1 country: see every site and its status.
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.