Determining Chewing Performance Level in Children

July 20, 2020 updated by: SELEN SEREL ARSLAN, Hacettepe University

Inter-rater Reliability in Determining Chewing Performance Level in Children

The study will investigate to verify whether pediatric dentists could determine chewing performance level by using Karaduman Chewing Performance Scale in children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The KCPS was developed by physical therapists who had expertise in pediatric swallowing disorders. This scale could be used as a practical tool to define chewing disorders as a common language for professionals due to its quick and easy to use features. However, its reliability in other professions has not been verified. The study will investigate to verify whether pediatric dentists could determine chewing performance level by using Karaduman Chewing Performance Scale in children.

Study Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacetttepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 10 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Typical developing children and children with cerebral palsy (CP) who will be referred to pediatric dentistry above the age of 2 years.

Description

Inclusion Criteria:

  • Typical developing children
  • Children with cerebral palsy (CP)
  • Above the age of 2 years

Exclusion Criteria:

  • Children who were under the age of 2 years
  • Who used any medicine and/or oral appliances that may affect chewing performance
  • Who had a previous evaluation of chewing function and received any chewing training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children with cerebral palsy
Children who will be referred to pediatric dentistry above the age of 2 years.
Diagnostic test: Karaduman Chewing Performance Scale
For chewing evaluation, children will be asked to bite and chew a standardized biscuit. Each chewing evaluation will be scored according to the KCPS.
Children with typical development
Children who will be referred to pediatric dentistry above the age of 2 years.
Diagnostic test: Karaduman Chewing Performance Scale
For chewing evaluation, children will be asked to bite and chew a standardized biscuit. Each chewing evaluation will be scored according to the KCPS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Karaduman Chewing Performance Scale
Time Frame: 2 months
The Karaduman Chewing Performance Scale is a 5 level ordinal scale between 0 to 4. Level 0 indicates Normal chewing, level 4 means No biting and chewing. Higher levels mean worse chewing performance level.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2020

Primary Completion (Actual)

July 15, 2020

Study Completion (Actual)

July 15, 2020

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

May 25, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Chewing performance level

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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