Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05650593
Other study ID # oral health in cp patients
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 6, 2022
Est. completion date May 1, 2023

Study information

Verified date December 2022
Source Cairo University
Contact s h khairy, baceloria
Phone 01090615775
Email sara.khairy@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date May 1, 2023
Est. primary completion date December 6, 2022
Accepts healthy volunteers
Gender All
Age group 4 Years to 14 Years
Eligibility Inclusion Criteria: Children diagnosed with Cerebral Palsy • Children aged from 4 to 14years old irrespective of sex. Exclusion Criteria: - The child is uncooperative. - Parents that refused to give informed consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt The National institute of Neuromotor System in Imbaba, Cairo, Egypt. Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
baseline
See also
  Status Clinical Trial Phase
Recruiting NCT05317234 - Genetic Predisposition in Cerebral Palsy N/A
Recruiting NCT05576948 - Natural History of Cerebral Palsy Prospective Study
Completed NCT04119063 - Evaluating Wearable Robotic Assistance on Gait Early Phase 1
Completed NCT03264339 - The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy N/A
Completed NCT05551364 - Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy N/A
Completed NCT03902886 - Independent Walking Onset of Children With Cerebral Palsy
Recruiting NCT05571033 - Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy N/A
Not yet recruiting NCT04081675 - Compliance in Children With Cerebral Palsy Supplied With AFOs
Completed NCT02167022 - Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy N/A
Completed NCT04012125 - The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy N/A
Enrolling by invitation NCT05619211 - Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities Phase 1
Completed NCT04489498 - Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Completed NCT03677193 - Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy N/A
Recruiting NCT06450158 - Robot-assisted Training in Children With CP N/A
Completed NCT04093180 - Intensive Neurorehabilitation for Cerebral Palsy N/A
Completed NCT02909127 - The Pediatric Eating Assessment Tool
Not yet recruiting NCT06377982 - Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy Phase 1
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT03183427 - Corpus Callosum Size in Patients With Pineal Cyst N/A
Active, not recruiting NCT03078621 - Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy Phase 1/Phase 2