AzTrials
AzTrials

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).

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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.

MENNATTALLAH ABDELRAHMAN, DDS contact

00905318561029

menna.darwesh@gmail.com

Turkey (Türkiye)1 site
  • Marmara University Researcy And Educational Hospital

    Istanbul

Other trials in Turkey (Türkiye)

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 groups in NCT03608969
Study groupRoleWhat they receive
Study GroupChildren 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.

  1. 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)
  1. 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

  2. Caries Status (the number of decayed (d, D) teeth) in the primary dentition

    the number of decayed (d, D) teeth)

    Measured: Day 0

  3. Caries Status (the number of decayed (d, D) teeth) in the permanent dentition

    the number of decayed (d, D) teeth)

    Measured: Day 0

  4. Caries Status (the number of missing (m,M) teeth) in the primary dentition

    the number of missing (m,M) teeth

    Measured: Day 0

  5. Caries Status (the number of missing (m,M) teeth) in the permanent dentition

    the number of missing (m,M) teeth

    Measured: Day 0

  6. Caries Status (the number of filled (f, F) teeth) in the primary dentition

    the number of filled (f, F) teeth

    Measured: Day 0

  7. Caries Status (the number of filled (f, F) teeth) in the permanent dentition

    the number of filled (f, F) teeth

    Measured: Day 0

  8. 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

  9. 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

  10. Gingival status

    Gingival status is used for the assessment of the gingival condition and records qualitative changes in the gingiva.

    Measured: Day 0

  11. 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

  12. 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

  13. 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

  14. 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.

  1. First posted1 Aug 2018
  2. Study start10 Aug 2018 (estimated)
  3. Primary completion30 Sep 2018 (estimated)
  4. Study completion30 Sep 2018 (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
Case only
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
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 16108461
  • 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.

    PubMed 17370477
  • Cruz 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 16601174
  • 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.

    PubMed 26407723
  • 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.

    PubMed 19269401
  • 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.

    PubMed 27617378
  • 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.

    PubMed 23063911
  • Bakke 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 17695052
  • Alev 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 19565403
  • 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.

    PubMed 15646914
  • 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.

    PubMed 18329448
  • 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. doi: 10.1136/bmj.322.7296.1240. No abstract available.

    PubMed 11358783
  • 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. doi: 10.1111/j.1752-7325.2003.tb03477.x.

    PubMed 12816135

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in