Chewing ProblemNCT04407455
Determining Chewing Performance Level in Children
An observational study of Chewing Problem, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The study will investigate to verify whether pediatric dentists could determine chewing performance level by using Karaduman Chewing Performance Scale in children. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Chewing Problem
- What is being tested?
- Karaduman Chewing Performance Scale
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 May 2020to 15 Jul 2020
- 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 2 to 12 years
- All sexes
- Child
Study population: Typical developing children and children with cerebral palsy (CP) who will be referred to pediatric dentistry above the age of 2 years.
Who may be able to join
- Typical developing children
- Children with cerebral palsy (CP)
- Above the age of 2 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chewing Problem
- Being tested
- Karaduman Chewing Performance Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with cerebral palsy | Children who will be referred to pediatric dentistry above the age of 2 years. Receives: Diagnostic Test: Karaduman Chewing Performance Scale | |
| Children with typical development | Children who will be referred to pediatric dentistry above the age of 2 years. Receives: Diagnostic Test: Karaduman Chewing Performance Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start27 May 2020
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chewing ProblemStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SELEN SEREL ARSLAN, Hacettepe University
- Investigators
- SELEN SEREL ARSLAN, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407455
- Sponsor's protocol ID
- Chewing performance level
- Status last verified
- Jul 2020
- First submitted
- 25 May 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33528675
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-rater Reliability in Determining Chewing Performance Level in Children
- ClinicalTrials.gov ID
- NCT04407455
- Acronym / sponsor ID
- Chewing performance level
- Conditions
- Chewing Problem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 29 May 2020 (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 study will investigate to verify whether pediatric dentists could determine chewing performance level by using Karaduman Chewing Performance Scale in children.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with cerebral palsy | – | Diagnostic Test: Karaduman Chewing Performance ScaleChildren who will be referred to pediatric dentistry above the age of 2 years. |
| Children with typical development | – | Diagnostic Test: Karaduman Chewing Performance ScaleChildren who will be referred to pediatric dentistry above the age of 2 years. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Typical developing children and children with cerebral palsy (CP) who will be referred to pediatric dentistry above the age of 2 years.
Key inclusion criteria (3 listed)
- Typical developing children
- Children with cerebral palsy (CP)
- Above the age of 2 years
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Karaduman Chewing Performance ScaleFor chewing evaluation, children will be asked to bite and chew a standardized biscuit. Each chewing evaluation will be scored according to the KCPS. | Diagnostic test | Children with cerebral palsy, Children with typical development |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Derived from this study: PubMed 33528675Serel 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.
- Individual participant dataSharing planned: No
Related trials for Chewing Problem
Active, not recruiting
Cognitive Changes and Neural Correlates After Rehabilitation of Masticatory Function in Elderly -an Intervention Study
Chewing Problem, Cognitive Decline
Not yet recruitingObservational study
Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT).
Mastication Disorder, Fatigue
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.
SELEN SEREL ARSLAN principal investigator
Hacettepe University
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 Chewing Problem, run by Hacettepe 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Karaduman Chewing Performance Scale (time frame: 2 months). 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 NCT04407455, which also lists 1 linked publication.
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 22 Jul 2020.