Cerebral Palsy Clinical Trial
Official title:
Prevalence of Orofacial Dysfunction in Cerebral Palsy Patients by Using Nordic Orofacial Test Screening (NOT-S) and Its Association With Oral Health Status and Quality of Life
The objective of this study is to analyze prevalence of orofacial dysfunction in children with cerebral palsy by using Nordic Orofacial Test screening (NOT-S) and its association with oral health status and quality of life.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | September 30, 2018 |
Est. primary completion date | September 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 16 Years |
Eligibility |
Inclusion Criteria: 1. Patients with cerebral palsy aged 3-16 who admit Pediatric Rehabilitation outpatient clinics of Department of Physical Therapy and Rehabilitation of Marmara University School of Medicine Exclusion Criteria: 1. Patients with uncooperative behavior or not able to understand verbal instructions. |
Country | Name | City | State |
---|---|---|---|
Turkey | Marmara University Researcy And Educational Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Marmara University |
Turkey,
Alev ALAÇAM, Arzu Sükran INCIOGLU. Turkish version of The Nordic Orofacial Test - Screening (NOT-S)
Bakke M, Bergendal B, McAllister A, Sjögreen L, Asten P. Development and evaluation of a comprehensive screening for orofacial dysfunction. Swed Dent J. 2007;31(2):75-84. — View Citation
Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. Review. — View Citation
Briesemeister M, Schmidt KC, Ries LG. Changes in masticatory muscle activity in children with cerebral palsy. J Electromyogr Kinesiol. 2013 Feb;23(1):260-6. doi: 10.1016/j.jelekin.2012.09.002. Epub 2012 Oct 12. — View Citation
Carr AJ, Gibson B, Robinson PG. Measuring quality of life: Is quality of life determined by expectations or experience? BMJ. 2001 May 19;322(7296):1240-3. — View Citation
Cruz M, Jenkins R, Silberberg D. The burden of brain disorders. Science. 2006 Apr 7;312(5770):53. — View Citation
Dougherty NJ. A review of cerebral palsy for the oral health professional. Dent Clin North Am. 2009 Apr;53(2):329-38, x. doi: 10.1016/j.cden.2008.12.001. Review. — View Citation
El Ashiry EA, Alaki SM, Nouri SM. Oral Health Quality of Life in Children with Cerebral Palsy: Parental Perceptions. J Clin Pediatr Dent. 2016;40(5):375-87. doi: 10.17796/1053-4628-40.5.375. — View Citation
Jokovic A, Locker D, Stephens M, Kenny D, Tompson B, Guyatt G. Measuring parental perceptions of child oral health-related quality of life. J Public Health Dent. 2003 Spring;63(2):67-72. — View Citation
Jokovic A, Locker D, Tompson B, Guyatt G. Questionnaire for measuring oral health-related quality of life in eight- to ten-year-old children. Pediatr Dent. 2004 Nov-Dec;26(6):512-8. — View Citation
Khandaker G, Smithers-Sheedy H, Islam J, Alam M, Jung J, Novak I, Booy R, Jones C, Badawi N, Muhit M. Bangladesh Cerebral Palsy Register (BCPR): a pilot study to develop a national cerebral palsy (CP) register with surveillance of children for CP. BMC Neurol. 2015 Sep 25;15:173. doi: 10.1186/s12883-015-0427-9. — View Citation
Lundeborg I, McAllister A, Graf J, Ericsson E, Hultcrantz E. Oral motor dysfunction in children with adenotonsillar hypertrophy--effects of surgery. Logoped Phoniatr Vocol. 2009;34(3):111-6. doi: 10.1080/14015430903066937. — View Citation
Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. Erratum in: Dev Med Child Neurol. 2007 Jun;49(6):480. — View Citation
Rozier RG, Pahel BT. Patient- and population-reported outcomes in public health dentistry: oral health-related quality of life. Dent Clin North Am. 2008 Apr;52(2):345-65, vi-vii. doi: 10.1016/j.cden.2007.12.002. Review. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nordic Orofacial Test-Screening (NOT-S) | it has 12 domains distributed between two sections. Six domains are based on an interview (sensory function, breathing, habits, chewing and swallowing, drooling and dry mouth) and six based on a clinical evaluation (face at rest, nose breathing, masticatory muscles and jaw function, oral motor function and speech). | Day 0 | |
Secondary | Parental- Caregiver Perceptions Questionnaire (P-CPQ) | Assesses oral health related quality of life. There are four domains tested to ascertain oral health quality of life: oral symptoms, functional limitations, emotional well-being and family well-being/parental distress. | Day 0 | |
Secondary | Caries Status (the number of decayed (d, D) teeth) in the primary dentition | the number of decayed (d, D) teeth) | Day 0 | |
Secondary | Caries Status (the number of decayed (d, D) teeth) in the permanent dentition | the number of decayed (d, D) teeth) | Day 0 | |
Secondary | Caries Status (the number of missing (m,M) teeth) in the primary dentition | the number of missing (m,M) teeth | Day 0 | |
Secondary | Caries Status (the number of missing (m,M) teeth) in the permanent dentition | the number of missing (m,M) teeth | Day 0 | |
Secondary | Caries Status (the number of filled (f, F) teeth) in the primary dentition | the number of filled (f, F) teeth | Day 0 | |
Secondary | Caries Status (the number of filled (f, F) teeth) in the permanent dentition | the number of filled (f, F) teeth | Day 0 | |
Secondary | Oral Hygiene Debris Index | Oral hygiene Debris Index is based on numerical determinations representing the amount of the debris found on the tooth surfaces. | Day 0 | |
Secondary | Oral Hygiene Calculus Index | Oral Hygiene Calculus Index is based on numerical determinations representing the amount of the calculus found on the tooth surfaces. | Day 0 | |
Secondary | Gingival status | Gingival status is used for the assessment of the gingival condition and records qualitative changes in the gingiva. | Day 0 | |
Secondary | Type of occlusion | it's classified into three categories: Class 1, Class 2 and Class 3. Teeth are aligned in Cusp Fossa relationship with their antagonist teeth. This is noted as "NORMAL" occlusion | Day 0 | |
Secondary | Communication Function Classification System (CFCS) | The CFCS is a tool used to classify the everyday communication of an individual with cerebral palsy into one of five levels according to effectiveness of communication | Day 0 | |
Secondary | Gross Motor Function Classification System (GMFCS) | a 5-level classification system that describes the gross motor function of children and youth with cerebral palsy on the basis of their self-initiated movement with particular emphasis on sitting, walking, and wheeled mobility | Day 0 | |
Secondary | Manual Ability Classification System (MACS) | The ability of children from 4 - 18 years old with cerebral palsy to handle objects in everyday activities can be categorised into 5 levels using MACS. | Day 0 |
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