Mastication DisorderNCT03116646
The Reliability and Validity of Family Report Chewing Evaluation
A study testing Chewing evaluation in people with Mastication Disorder, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The family has a primary prescription in the identification of the chewing disorder in children to plan appropriate rehabilitation program and implementation of the training. Therefore, it is very important to investigate the validity and reliability of classification systems that can be applied by parents. Read more about this study
- Who is it for?
- Ages 18 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mastication Disorder
- What is being tested?
- Chewing evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2019to 20 Nov 2019
- Phase
- Interventional
- 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 18 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children above the age of 18 months
- Children with chewing disorders
Who cannot join
- Children below the age of 18 months
- Children without chewing disorders
Trial locations and contacts
1 site in 1 country.
About this study
The family has a primary prescription in the identification of the chewing disorder in children to plan appropriate rehabilitation program and implementation of the training. Therefore, it is very important to investigate the validity and reliability of classification systems that can be applied by parents. The purpose of this study is to determine the validity and reliability of the reliability and validity of family report chewing evaluation.
Read the detailed description
Chewing is a function that is defined as the grinding of solid food and making them ready for swallowing. Chewing begins with the acceptance of solid food with the lips. The rotational and lateral movements of the tongue is also necessary during grinding the solid food in the molar region. In the molar region, grinding is carried out with the help of salivary and salivary enzymes. Chewing behavior is a learned function. The child begins to chew at 6 months and the coordinated movement to the 9th month continues to develop. Together with experience, chewing activity continues to develop. The families have a primary role in chewing training. In some children, the chewing function does not develop as desired. Many children with developmental, medical, or oral motor problems have difficulty in grinding and swallowing solid foods. Therefore, it is very important to assess the ability of the child's chewing and determine the treatment goals. Assessment of the child's ability to chew should begin by considering chewing as a function. For this reason, the Karaduman Chewing Performance Scale (KCPS) was developed at the Hacettepe University, Faculty of Health Sciences Department of Physiotherapy and Rehabilitation. The chewing performance of the child during chewing a biscuit is scored by the therapist between 0-4. 0 refers to normal chewing, 4 means no bite and chew. The family has a primary prescription in the identification of the chewing disorder in children to plan appropriate rehabilitation program and implementation of the training. Therefore, it is very important to investigate the validity and reliability of classification systems that can be applied by parents. The purpose of this study is to determine the validity and reliability of the reliability and validity of family report chewing evaluation (Karaduman Chewing Performance Scale-Family report).
- Conditions
- Mastication Disorder
- Being tested
- Chewing evaluation
- Keywords
- mastication, cerebral palsy, family
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing evaluationDiagnostic test
Children with chewing disorders will be recruited. Each child is required to bite and chew a standardized biscuit for chewing evaluation. The chewing function of each child is scored with the Karaduman Chewing Performance Scale by a physical therapist. Then, the chewing function of each child is also scored with the Karaduman Chewing Performance Scale-Family report by their families.
| Study group | Role | What they receive |
|---|---|---|
| Chewing evaluation | Experimental | Children with chewing disorders will be recruited. Each child is required to bite and chew a standardized biscuit for chewing evaluation. The chewing function of each child is scored with the Karaduman Chewing Performance Scale by a physical therapist. Then, the chewing function of each child is also scored with the Karaduman Chewing Performance Scale-Family report by their families. Receives: Diagnostic Test: Chewing evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chewing evaluation
Each child is required to bite and chew a standardized biscuit for chewing evaluation. The chewing function of each child is scored with the Karaduman Chewing Performance Scale.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start15 Mar 2019
- Primary completion20 Nov 2019
- Study completion20 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastication DisorderStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116646
- Sponsor's protocol ID
- Family report chewing function
- Status last verified
- May 2020
- First submitted
- 11 Apr 2017
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of Family Report Chewing Evaluation
- ClinicalTrials.gov ID
- NCT03116646
- Acronym / sponsor ID
- Family report chewing function
- Conditions
- Mastication Disorder
- Keywords
- mastication, cerebral palsy, family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 17 Apr 2017 (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 family has a primary prescription in the identification of the chewing disorder in children to plan appropriate rehabilitation program and implementation of the training. Therefore, it is very important to investigate the validity and reliability of classification systems that can be applied by parents. The purpose of this study is to determine the validity and reliability of the reliability and validity of family report chewing evaluation.
Detailed description
Chewing is a function that is defined as the grinding of solid food and making them ready for swallowing. Chewing begins with the acceptance of solid food with the lips. The rotational and lateral movements of the tongue is also necessary during grinding the solid food in the molar region. In the molar region, grinding is carried out with the help of salivary and salivary enzymes. Chewing behavior is a learned function. The child begins to chew at 6 months and the coordinated movement to the 9th month continues to develop. Together with experience, chewing activity continues to develop. The families have a primary role in chewing training. In some children, the chewing function does not develop as desired. Many children with developmental, medical, or oral motor problems have difficulty in grinding and swallowing solid foods. Therefore, it is very important to assess the ability of the child's chewing and determine the treatment goals. Assessment of the child's ability to chew should begin by considering chewing as a function. For this reason, the Karaduman Chewing Performance Scale (KCPS) was developed at the Hacettepe University, Faculty of Health Sciences Department of Physiotherapy and Rehabilitation. The chewing performance of the child during chewing a biscuit is scored by the therapist between 0-4. 0 refers to normal chewing, 4 means no bite and chew. The family has a primary prescription in the identification of the chewing disorder in children to plan appropriate rehabilitation program and implementation of the training. Therefore, it is very important to investigate the validity and reliability of classification systems that can be applied by parents. The purpose of this study is to determine the validity and reliability of the reliability and validity of family report chewing evaluation (Karaduman Chewing Performance Scale-Family report).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chewing evaluation | Experimental | Diagnostic Test: Chewing evaluationChildren with chewing disorders will be recruited. Each child is required to bite and chew a standardized biscuit for chewing evaluation. The chewing function of each child is scored with the Karaduman Chewing Performance Scale by a physical therapist. Then, the chewing function of each child is also scored with the Karaduman Chewing Performance Scale-Family report by their families. |
Who may qualify
- Ages
- 18 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children above the age of 18 months
- Children with chewing disorders
Key exclusion criteria (2 listed)
- Children below the age of 18 months
- Children without chewing disorders
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 |
|---|---|---|
| Chewing evaluationChildren with chewing disorders will be recruited. Each child is required to bite and chew a standardized biscuit for chewing evaluation. The chewing function of each child is scored with the Karaduman Chewing Performance Scale by a physical therapist. Then, the chewing function of each child is also scored with the Karaduman Chewing Performance Scale-Family report by their families. | Diagnostic test | Chewing evaluation |
Primary outcome
Chewing evaluation
Time frame: 1 month
Each child is required to bite and chew a standardized biscuit for chewing evaluation. The chewing function of each child is scored with the Karaduman Chewing Performance Scale.
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 2 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Mastication Disorder
Recruiting
Nutritional Intervention for Older Adults With Complete Dentures
Edentulism Complete, Denture, Complete
Active, not recruiting
Cognitive Changes and Neural Correlates After Rehabilitation of Masticatory Function in Elderly -an Intervention Study
Chewing Problem, Cognitive Decline
RecruitingObservational study
Occlusal Equilibration vs. Sham Therapies for TMDs: Post-Trial Follow-up (OEST)
Temporomandibular Disorders (TMD), Myalgia of Mastication Muscle
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, PhD 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?
A study testing Chewing evaluation in people with Mastication Disorder, 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 2 inclusion and 2 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 2 Jun 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?
Chewing evaluation (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2020; AzTrials last refreshed its copy on 6 Nov 2026.