NCT04407455

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 25, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

May 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

May 25, 2020

Last Update Submit

July 20, 2020

Conditions

Chewing Problem

Outcome Measures

Primary Outcomes (1)

  • Karaduman Chewing Performance Scale

    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

Study Arms (2)

Children with cerebral palsy

Children who will be referred to pediatric dentistry above the age of 2 years.

Diagnostic Test: Karaduman Chewing Performance Scale

Children with typical development

Children who will be referred to pediatric dentistry above the age of 2 years.

Diagnostic Test: Karaduman Chewing Performance Scale

Interventions

Karaduman Chewing Performance ScaleDIAGNOSTIC_TEST

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 cerebral palsyChildren with typical development

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacetttepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • Serel Arslan S, Ozsin Ozler C, Demir N, Ozturk S, Uzamis Tekcicek M, Karaduman AA. Pediatric dentists can determine chewing performance level in children. Clin Oral Investig. 2021 Aug;25(8):5043-5048. doi: 10.1007/s00784-021-03815-w. Epub 2021 Feb 2.

    PMID: 33528675DERIVED

Study Officials

  • SELEN SEREL ARSLAN

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2020

First Posted

May 29, 2020

Study Start

May 27, 2020

Primary Completion

July 15, 2020

Study Completion

July 15, 2020

Last Updated

July 22, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)