Cerebral PalsyNCT03608969
Orofacial Dysfunction in Cerebral Palsy Patients and Its Association With Oral Health Status and Quality of Life
An observational study of Cerebral Palsy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- NOT-S
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2018to 30 Sep 2018
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with cerebral palsy aged 3-16 years
Who may be able to join
- 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
Who cannot join
- 1. Patients with uncooperative behavior or not able to understand verbal instructions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Researcy And Educational Hospital
Istanbul
About this study
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.
Read the detailed description
Cerebral palsy (CP) is a group of neurodevelopmental conditions characterized by motor disorders, where orofacial functions, such as controlling saliva, talking, and eating are often affected. Impaired eating is associated with poor growth and problems with chewing and swallowing problems may jeopardize respiration. Notably, the most common causes of death in young individuals with CP are secondary respiratory diseases. Hence, dysfunction in the face, tongue, palate and throat, generically termed orofacial dysfunction has a strong impact on health in individuals with CP. From a dental point of view, early examinations for intervention and prevention among children in general (and those with special needs specifically) are strongly recommended by major dental academies. However, because children with CP have multiple medical issues, their dental issues might not receive equal consideration from healthcare providers trying to provide the best comprehensive care. This can create significant morbidity that can further affect the wellbeing of these compromised children and negatively impact their quality of life.
This study will evaluate the relationship among orofacial functions, manual ability, gross motor function and oral health related quality of life (OHRQOL) in parents / caregivers. One hundred child (4-16 years) will be assessed for orofacial function using the Turkish version for the Nordic Orofacial Test-Screening (NOT-S) protocol, which consists of a structured interview and clinical examination. In NOT-S, aspects of orofacial dysfunction are termed domains. Each domain consists of questions or tasks, which are termed items. Each item serves to discriminate between normal function and dysfunction. The domains and items were finally formulated through discussions in the development team. The NOT-S consists of a structured interview, registering everyday orofacial functions, and a basic clinical examination registering intentional sensory-motor control via the cranial nerves. The interview contains six domains: 'Sensory function', 'Breathing', 'Habits', 'Chewing and swallowing', 'Drooling', and 'Dryness of the mouth'. The examination contains six domains: 'Face at rest', 'Nose breathing', 'Facial expression', 'Masticatory muscle and jaw function', 'Oral motor function', and 'Speech'. Each domain comprises one to five items. Each item is rated with 'yes', if the criterion of dysfunction is fulfilled, or 'no', if not fulfilled. If one or more items within a domain are assessed with 'yes', dysfunction is indicated in the domain.
Self-initiated functional ability will be classified according to the expanded and revised version of the Gross Motor Function Classification System (GMFCS) and Manual Ability Classification System (MACS). Both GMFCS and MACS are five-level systems (I-V) in which level I represents minor and level V represents major limitations in function and ability. Caries Status Caries status will be determined by recording the number of decayed (d, D), missing (m,M), and filled (f, F) teeth in the primary and permanent dentition. With the decayed, missing, and filled teeth (DMFT) index for permanent, and DMFT index for primary dentition we will assess the mean dental caries scores for every individual.
Oral hygiene is a basic factor for oral health. Poor oral hygiene leads to dental plaque collections, which with times turns into the calculus as finally can cause gingivitis and periodontal diseases. That is why many studies, also ours, have been carried out focusing on the role of oral hygiene. Some indices have been developed for assessing individual levels of oral health status. In this study, we decided to use Simplified Oral Hygiene Index (OHI-S). The OHI-S differs from the original OHI in the number of the tooth surfaces scored. Instead of 12, there are just six surfaces. The OHI-S has two components, the Debris Index and the Calculus Index. Each of these indexes is based on numerical determinations representing the amount of the debris or calculus found on the tooth surfaces. The six surfaces examined for the OHI-S are selected from four posterior and two anterior teeth.
Oral health related quality of life measures the functional and psychosocial outcomes of oral disorders. It is now generally accepted in the research community that they are essential as clinical indicators when assessing the oral health of individuals and populations, making clinical decisions, and evaluating dental interventions, services, and programs. According to the US Surgeon General, oral disease and conditions can "…undermine self-image and self-esteem, discourage normal social interaction, and cause other health problems and lead to chronic stress and depression as well as incur great financial cost. They may also interfere with vital functions such as breathing, food selection eating, swallowing and speaking, and with activities of daily living such as work, school, and family interactions". People assess their HRQOL by comparing their expectations and experiences. Parental- Caregiver Perceptions Questionnaire (P-CPQ) was developed to measure parental or caregiver perceptions of a child's OHRQOL and the impact of the child's condition on the family.
The objective of this study is to analyze prevalence of orofacial dysfunction in cerebral palsy patients by using NOT-S and its association with OHRQOL.
- Conditions
- Cerebral Palsy
- Being tested
- NOT-S
- Keywords
- Cerebral palsy, Orofacial dysfunction, Oral Health, Quality of Life
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOT-SOther
Also called Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), Communication Function Scale (CFS), The decayed, missing, and filled teeth (DMFT) index
Participants are assessed for the orofacial function using the Nordic Orofacial test- screening (NOT-S), Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS) and Communication Function Scale (CFS). Oral health related quality of life is assessed using the Parental- Caregiver Perceptions Questionnaire (P-CPQ). Caries experience was measured by identifying decayed, missing, and filled teeth for deciduous and permanent teeth (dmft). Gingival index and type of occlusion will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Children with cerebral palsy aged 3-16 years will be evaluated in terms of the orofacial function using the Nordic Orofacial test- screening (NOT-S). Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS) level and Communication Function Scale (CFS) of child will be recorded. Oral health related quality of life will be assessed using the Parental- Caregiver Perceptions Questionnaire. Caries experience will be measured by identifying decayed, missing, and filled teeth for deciduous and permanent teeth (dmft) Receives: Other: NOT-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 0
Secondary outcomes (14)
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.
Measured: Day 0
Caries Status (the number of decayed (d, D) teeth) in the primary dentition
the number of decayed (d, D) teeth)
Measured: Day 0
Caries Status (the number of decayed (d, D) teeth) in the permanent dentition
the number of decayed (d, D) teeth)
Measured: Day 0
Caries Status (the number of missing (m,M) teeth) in the primary dentition
the number of missing (m,M) teeth
Measured: Day 0
Caries Status (the number of missing (m,M) teeth) in the permanent dentition
the number of missing (m,M) teeth
Measured: Day 0
Caries Status (the number of filled (f, F) teeth) in the primary dentition
the number of filled (f, F) teeth
Measured: Day 0
Caries Status (the number of filled (f, F) teeth) in the permanent dentition
the number of filled (f, F) teeth
Measured: Day 0
Oral Hygiene Debris Index
Oral hygiene Debris Index is based on numerical determinations representing the amount of the debris found on the tooth surfaces.
Measured: Day 0
Oral Hygiene Calculus Index
Oral Hygiene Calculus Index is based on numerical determinations representing the amount of the calculus found on the tooth surfaces.
Measured: Day 0
Gingival status
Gingival status is used for the assessment of the gingival condition and records qualitative changes in the gingiva.
Measured: Day 0
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
Measured: Day 0
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
Measured: Day 0
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
Measured: Day 0
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start10 Aug 2018 (estimated)
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- İlknur Tanboğa, Prof.Dr., Study director, Marmara university Faculty of DentistryEvrim Karadağ, prof.Dr., Study director, Marmara Universitylşıl Özgül Kalyoncu, Asst. Prof., Study director, Marmara University Faculty of DentistryEsra Giray, MD, Study director, Marmara UniversityLouay Akkash, DDS, Principal investigator, Marmara university Faculty of DentistryMENNATTALLAH ABDELRAHMAN, DDS, Principal investigator, Marmara university Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608969
- Sponsor's protocol ID
- 2017-112
- Status last verified
- Jul 2018
- First submitted
- 5 Jun 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Publications
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. doi: 10.1017/s001216220500112x.
PubMed 16108461Rosenbaum 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.
PubMed 17370477Cruz M, Jenkins R, Silberberg D. The burden of brain disorders. Science. 2006 Apr 7;312(5770):53. doi: 10.1126/science.312.5770.53b. No abstract available.
PubMed 16601174Khandaker 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.
PubMed 26407723Dougherty 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.
PubMed 19269401El 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.
PubMed 27617378Briesemeister 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.
PubMed 23063911Bakke M, Bergendal B, McAllister A, Sjogreen L, Asten P. Development and evaluation of a comprehensive screening for orofacial dysfunction. Swed Dent J. 2007;31(2):75-84.
PubMed 17695052Alev ALAÇAM, Arzu Şükran İNCİOĞLU. Turkish version of The Nordic Orofacial Test - Screening (NOT-S)
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.
PubMed 19565403Jokovic 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.
PubMed 15646914Rozier 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.
PubMed 18329448Carr 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. doi: 10.1136/bmj.322.7296.1240. No abstract available.
PubMed 11358783Jokovic 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. doi: 10.1111/j.1752-7325.2003.tb03477.x.
PubMed 12816135
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03608969
- Acronym / sponsor ID
- 2017-112
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Orofacial dysfunction, Oral Health, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 10 Aug 2018 (estimated)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 1 Aug 2018 (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 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.
Detailed description
Cerebral palsy (CP) is a group of neurodevelopmental conditions characterized by motor disorders, where orofacial functions, such as controlling saliva, talking, and eating are often affected. Impaired eating is associated with poor growth and problems with chewing and swallowing problems may jeopardize respiration. Notably, the most common causes of death in young individuals with CP are secondary respiratory diseases. Hence, dysfunction in the face, tongue, palate and throat, generically termed orofacial dysfunction has a strong impact on health in individuals with CP. From a dental point of view, early examinations for intervention and prevention among children in general (and those with special needs specifically) are strongly recommended by major dental academies. However, because children with CP have multiple medical issues, their dental issues might not receive equal consideration from healthcare providers trying to provide the best comprehensive care. This can create significant morbidity that can further affect the wellbeing of these compromised children and negatively impact their quality of life.
This study will evaluate the relationship among orofacial functions, manual ability, gross motor function and oral health related quality of life (OHRQOL) in parents / caregivers. One hundred child (4-16 years) will be assessed for orofacial function using the Turkish version for the Nordic Orofacial Test-Screening (NOT-S) protocol, which consists of a structured interview and clinical examination. In NOT-S, aspects of orofacial dysfunction are termed domains. Each domain consists of questions or tasks, which are termed items. Each item serves to discriminate between normal function and dysfunction. The domains and items were finally formulated through discussions in the development team. The NOT-S consists of a structured interview, registering everyday orofacial functions, and a basic clinical examination registering intentional sensory-motor control via the cranial nerves. The interview contains six domains: 'Sensory function', 'Breathing', 'Habits', 'Chewing and swallowing', 'Drooling', and 'Dryness of the mouth'. The examination contains six domains: 'Face at rest', 'Nose breathing', 'Facial expression', 'Masticatory muscle and jaw function', 'Oral motor function', and 'Speech'. Each domain comprises one to five items. Each item is rated with 'yes', if the criterion of dysfunction is fulfilled, or 'no', if not fulfilled. If one or more items within a domain are assessed with 'yes', dysfunction is indicated in the domain.
Self-initiated functional ability will be classified according to the expanded and revised version of the Gross Motor Function Classification System (GMFCS) and Manual Ability Classification System (MACS). Both GMFCS and MACS are five-level systems (I-V) in which level I represents minor and level V represents major limitations in function and ability. Caries Status Caries status will be determined by recording the number of decayed (d, D), missing (m,M), and filled (f, F) teeth in the primary and permanent dentition. With the decayed, missing, and filled teeth (DMFT) index for permanent, and DMFT index for primary dentition we will assess the mean dental caries scores for every individual.
Oral hygiene is a basic factor for oral health. Poor oral hygiene leads to dental plaque collections, which with times turns into the calculus as finally can cause gingivitis and periodontal diseases. That is why many studies, also ours, have been carried out focusing on the role of oral hygiene. Some indices have been developed for assessing individual levels of oral health status. In this study, we decided to use Simplified Oral Hygiene Index (OHI-S). The OHI-S differs from the original OHI in the number of the tooth surfaces scored. Instead of 12, there are just six surfaces. The OHI-S has two components, the Debris Index and the Calculus Index. Each of these indexes is based on numerical determinations representing the amount of the debris or calculus found on the tooth surfaces. The six surfaces examined for the OHI-S are selected from four posterior and two anterior teeth.
Oral health related quality of life measures the functional and psychosocial outcomes of oral disorders. It is now generally accepted in the research community that they are essential as clinical indicators when assessing the oral health of individuals and populations, making clinical decisions, and evaluating dental interventions, services, and programs. According to the US Surgeon General, oral disease and conditions can "…undermine self-image and self-esteem, discourage normal social interaction, and cause other health problems and lead to chronic stress and depression as well as incur great financial cost. They may also interfere with vital functions such as breathing, food selection eating, swallowing and speaking, and with activities of daily living such as work, school, and family interactions". People assess their HRQOL by comparing their expectations and experiences. Parental- Caregiver Perceptions Questionnaire (P-CPQ) was developed to measure parental or caregiver perceptions of a child's OHRQOL and the impact of the child's condition on the family.
The objective of this study is to analyze prevalence of orofacial dysfunction in cerebral palsy patients by using NOT-S and its association with OHRQOL.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: NOT-SChildren with cerebral palsy aged 3-16 years will be evaluated in terms of the orofacial function using the Nordic Orofacial test- screening (NOT-S). Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS) level and Communication Function Scale (CFS) of child will be recorded. Oral health related quality of life will be assessed using the Parental- Caregiver Perceptions Questionnaire. Caries experience will be measured by identifying decayed, missing, and filled teeth for deciduous and permanent teeth (dmft) |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with cerebral palsy aged 3-16 years
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Patients with uncooperative behavior or not able to understand verbal instructions.
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 |
|---|---|---|
| NOT-SAlso: Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), Communication Function Scale (CFS), The decayed, missing, and filled teeth (DMFT) indexParticipants are assessed for the orofacial function using the Nordic Orofacial test- screening (NOT-S), Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS) and Communication Function Scale (CFS). Oral health related quality of life is assessed using the Parental- Caregiver Perceptions Questionnaire (P-CPQ). Caries experience was measured by identifying decayed, missing, and filled teeth for deciduous and permanent teeth (dmft). Gingival index and type of occlusion will be recorded. | Other | Study Group |
Primary outcome
Nordic Orofacial Test-Screening (NOT-S)
Time frame: Day 0
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).
14 secondary outcomes
Parental- Caregiver Perceptions Questionnaire (P-CPQ)
Time frame: Day 0
Caries Status (the number of decayed (d, D) teeth) in the primary dentition
Time frame: Day 0
Caries Status (the number of decayed (d, D) teeth) in the permanent dentition
Time frame: Day 0
Caries Status (the number of missing (m,M) teeth) in the primary dentition
Time frame: Day 0
Caries Status (the number of missing (m,M) teeth) in the permanent dentition
Time frame: Day 0
Caries Status (the number of filled (f, F) teeth) in the primary dentition
Time frame: Day 0
Caries Status (the number of filled (f, F) teeth) in the permanent dentition
Time frame: Day 0
Oral Hygiene Debris Index
Time frame: Day 0
Oral Hygiene Calculus Index
Time frame: Day 0
Gingival status
Time frame: Day 0
Type of occlusion
Time frame: Day 0
Communication Function Classification System (CFCS)
Time frame: Day 0
Gross Motor Function Classification System (GMFCS)
Time frame: Day 0
Manual Ability Classification System (MACS)
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Background: PubMed 16108461Bax 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. doi: 10.1017/s001216220500112x.
- Background: PubMed 17370477Rosenbaum 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.
- Background: PubMed 16601174Cruz M, Jenkins R, Silberberg D. The burden of brain disorders. Science. 2006 Apr 7;312(5770):53. doi: 10.1126/science.312.5770.53b. No abstract available.
- Background: PubMed 26407723Khandaker 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.
- Background: PubMed 19269401Dougherty 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.
- Background: PubMed 27617378El 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.
- Background: PubMed 23063911Briesemeister 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.
- Background: PubMed 17695052Bakke M, Bergendal B, McAllister A, Sjogreen L, Asten P. Development and evaluation of a comprehensive screening for orofacial dysfunction. Swed Dent J. 2007;31(2):75-84.
- BackgroundAlev ALAÇAM, Arzu Şükran İNCİOĞLU. Turkish version of The Nordic Orofacial Test - Screening (NOT-S)
- Background: PubMed 19565403Lundeborg 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.
- Background: PubMed 15646914Jokovic 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.
- Background: PubMed 18329448Rozier 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.
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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.
İlknur Tanboğa, Prof.Dr. study director
Marmara university Faculty of Dentistry
Evrim Karadağ, prof.Dr. study director
Marmara University
lşıl Özgül Kalyoncu, Asst. Prof. study director
Marmara University Faculty of Dentistry
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 Marmara University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 1 Aug 2018. 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 Turkey (Türkiye). 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 MENNATTALLAH ABDELRAHMAN, DDS (00905318561029, menna.darwesh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nordic Orofacial Test-Screening (NOT-S) (time frame: Day 0). 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 NCT03608969, which also lists 14 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 1 Aug 2018; AzTrials last refreshed its copy on 1 Nov 2026.