Mastication DisorderNCT03194048
Effect of Functional Chewing Training on Tongue Thrust and Drooling in Children With Cerebral Palsy
A study testing Functional Chewing Training and Classical Oral Motor Exercises in people with Mastication Disorder, run by Hacettepe University.
Trial summary
This study examined the effect of Functional Chewing Training(FuCT) on tongue thrust and drooling in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Mastication Disorder
- What is being tested?
- Functional Chewing Training and Classical Oral Motor Exercises
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2015to 1 Apr 2016
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed with cerebral palsy
- aged between 4-6 years
- fed by orally
- had tongue thrust
Who cannot join
- children who were unable the sitting position
About this study
Official title: Effect of Functional Chewing Training on Tongue Thrust and Drooling in Children With Cerebral Palsy: A Randomised Controlled Trial
This study examined the effect of Functional Chewing Training(FuCT) on tongue thrust and drooling in children with cerebral palsy.
Read the detailed description
Children were divided into two groups: The FuCT group and control group receiving classical oral motor exercises. Each group received training for 12 weeks. Oral motor assessment was performed. Chewing performance level was determined with the Karaduman Chewing Performance Scale(KCPS). Tongue thrust severity was evaluated with the Tongue Thrust Rating Scale(TTRS). The Drooling Severity and Frequency Scale(DSFS) was used to evaluate drooling severity and frequency. The evaluations were performed before and after treatment.
- Conditions
- Mastication Disorder
- Being tested
- Functional Chewing Training, Classical Oral Motor Exercises
- Keywords
- drooling, tongue thrust
- Medical subject headings
- Sialorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Chewing TrainingOther
Also called FuCT
FuCT;
- Family training
- Providing optimal sitting posture for children to support oral sensorimotor functions
- Positioning the food to the molar area during every meal to stimulate lateral and rotational tongue movements
- Massage of the upper and lower gums through the front teeth to molar area
- Chewing training to stimulate lateral and rotational tongue movements
- Gradually increasing the food consistency, for 12 weeks in 5 sets (1 set = 20 min) each day
Classical Oral Motor ExercisesOther
Classical Oral Motor Exercises;
- Family training
- passive and active lip and tongue exercises, for 12 weeks in 5 sets (1 set = 20 min) each day
| Study group | Role | What they receive |
|---|---|---|
| Functional Chewing Training | Experimental | Children with CP and have tongue thrust included this group. Receives: Other: Functional Chewing Training |
| Control | Active comparator | Children with CP and have tongue thrust included this group. Receives: Other: Classical Oral Motor Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tongue Thrust Rating Scale
Tongue thrust for each child is scored while they are feeding.
Measured: 12 weeks
Secondary outcomes (1)
The Drooling Severity and Frequency Scale
Parents were asked how often and in which severity experiencing drooling their children.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start16 Dec 2015
- Primary completion20 Dec 2015
- Study completion1 Apr 2016
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgü İNAL, Hacettepe University
- Investigators
- Özgü İnal, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194048
- Sponsor's protocol ID
- özgü inal
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2017
- Last updated
- 21 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rempel GR, Colwell SO, Nelson RP. Growth in children with cerebral palsy fed via gastrostomy. Pediatrics. 1988;82:857-862. Allen MC, Capute A. The evolution of primitive reflexes in extremely premature infants. Pediatr Res. 1986;20:1284-1289. Blasco PA. Primitive reflexes: their contribution to the early detection of cerebral palsy. Clinical pediatrics. 1994;33:388-397. Singh S, Dua P, Jain S. Habit breaking appliance for tongue thrusting-a modification. Indian J Dent Sci. 2011;3:10.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Functional Chewing Training on Tongue Thrust and Drooling in Children With Cerebral Palsy: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03194048
- Acronym / sponsor ID
- özgü inal
- Conditions
- Mastication Disorder
- Keywords
- drooling, tongue thrust
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 16 Dec 2015 (actual)
- Primary completion
- 20 Dec 2015 (actual)
- Study completion
- 1 Apr 2016 (actual)
- First posted
- 21 Jun 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.
This study examined the effect of Functional Chewing Training(FuCT) on tongue thrust and drooling in children with cerebral palsy.
Detailed description
Children were divided into two groups: The FuCT group and control group receiving classical oral motor exercises. Each group received training for 12 weeks. Oral motor assessment was performed. Chewing performance level was determined with the Karaduman Chewing Performance Scale(KCPS). Tongue thrust severity was evaluated with the Tongue Thrust Rating Scale(TTRS). The Drooling Severity and Frequency Scale(DSFS) was used to evaluate drooling severity and frequency. The evaluations were performed before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Chewing Training | Experimental | Other: Functional Chewing TrainingChildren with CP and have tongue thrust included this group. |
| Control | Active comparator | Other: Classical Oral Motor ExercisesChildren with CP and have tongue thrust included this group. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- diagnosed with cerebral palsy
- aged between 4-6 years
- fed by orally
- had tongue thrust
Key exclusion criteria (1 listed)
- children who were unable the sitting position
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 |
|---|---|---|
| Functional Chewing TrainingAlso: FuCTFuCT; * Family training * Providing optimal sitting posture for children to support oral sensorimotor functions * Positioning the food to the molar area during every meal to stimulate lateral and rotational tongue movements * Massage of the upper and lower gums through the front teeth to molar area * Chewing training to stimulate lateral and rotational tongue movements * Gradually increasing the food consistency, for 12 weeks in 5 sets (1 set = 20 min) each day | Other | Functional Chewing Training |
| Classical Oral Motor ExercisesClassical Oral Motor Exercises; * Family training * passive and active lip and tongue exercises, for 12 weeks in 5 sets (1 set = 20 min) each day | Other | Control |
Primary outcome
Tongue Thrust Rating Scale
Time frame: 12 weeks
Tongue thrust for each child is scored while they are feeding.
1 secondary outcome
The Drooling Severity and Frequency Scale
Time frame: 12 weeks
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 21 Jun 2017.
- BackgroundRempel GR, Colwell SO, Nelson RP. Growth in children with cerebral palsy fed via gastrostomy. Pediatrics. 1988;82:857-862. Allen MC, Capute A. The evolution of primitive reflexes in extremely premature infants. Pediatr Res. 1986;20:1284-1289. Blasco PA. Primitive reflexes: their contribution to the early detection of cerebral palsy. Clinical pediatrics. 1994;33:388-397. Singh S, Dua P, Jain S. Habit breaking appliance for tongue thrusting-a modification. Indian J Dent Sci. 2011;3:10.
- Individual participant dataSharing planned: Undecided
Related trials for Mastication Disorder
Recruiting
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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.
Özgü İnal principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing Functional Chewing Training and Classical Oral Motor Exercises in people with Mastication Disorder, run by Hacettepe University.
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 4 inclusion and 1 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 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Tongue Thrust Rating Scale (time frame: 12 weeks). 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 NCT03194048, 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 21 Jun 2017; AzTrials last refreshed its copy on 2 Nov 2026.