NCT03608969

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

August 10, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

2 months

First QC Date

June 5, 2018

Last Update Submit

July 31, 2018

Conditions

Cerebral Palsy

Keywords

Cerebral palsyOrofacial dysfunctionOral HealthQuality of Life

Outcome Measures

Primary Outcomes (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).

    Day 0

Secondary Outcomes (14)

  • Parental- Caregiver Perceptions Questionnaire (P-CPQ)

    Day 0

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

    Day 0

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

    Day 0

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

    Day 0

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

    Day 0

  • +9 more secondary outcomes

Study Arms (1)

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)

Other: NOT-S

Interventions

NOT-SOTHER

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.

Also known as: Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), Communication Function Scale (CFS), The decayed, missing, and filled teeth (DMFT) index, Parental- Caregiver Perceptions Questionnaire (P-CPQ), Simplified Oral Hygiene Index (OHI-S), Gingival index, Type of occlusion
Study Group

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients with cerebral palsy aged 3-16 years

You may qualify if:

  • \. 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

You may not qualify if:

  • \. Patients with uncooperative behavior or not able to understand verbal instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Researcy And Educational Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (14)

  • 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.

    PMID: 16108461BACKGROUND

  • 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.

    PMID: 17370477BACKGROUND

  • 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.

    PMID: 16601174BACKGROUND

  • 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.

    PMID: 26407723BACKGROUND

  • 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.

    PMID: 19269401BACKGROUND

  • 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.

    PMID: 27617378BACKGROUND

  • 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.

    PMID: 23063911BACKGROUND

  • 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.

    PMID: 17695052BACKGROUND

  • Alev ALAÇAM, Arzu Şükran İNCİOĞLU. Turkish version of The Nordic Orofacial Test - Screening (NOT-S)

    BACKGROUND

  • 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.

    PMID: 19565403BACKGROUND

  • 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.

    PMID: 15646914BACKGROUND

  • 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.

    PMID: 18329448BACKGROUND

  • 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.

    PMID: 11358783BACKGROUND

  • 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.

    PMID: 12816135BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Dental Health SurveysHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDentistryPeriodonticsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Dentistry

Study Officials

  • İlknur Tanboğa, Prof.Dr.

    Marmara university Faculty of Dentistry

    STUDY DIRECTOR

  • Evrim Karadağ, prof.Dr.

    Marmara University

    STUDY DIRECTOR

  • lşıl Özgül Kalyoncu, Asst. Prof.

    Marmara University Faculty of Dentistry

    STUDY DIRECTOR

  • Esra Giray, MD

    Marmara University

    STUDY DIRECTOR

  • Louay Akkash, DDS

    Marmara university Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

  • MENNATTALLAH ABDELRAHMAN, DDS

    Marmara university Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MENNATTALLAH ABDELRAHMAN, DDS

CONTACT

00905318561029menna.darwesh@gmail.com

Esra Giray, MD

CONTACT

2166570606girayesra@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2018

First Posted

August 1, 2018

Study Start

August 10, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

August 1, 2018

Record last verified: 2018-07

Locations

TU(1)