Cerebral PalsyNCT05212415
Bruxism and Parafunctional Oral Habits in Children and Adolescents With Cerebral Palsy
An observational study of Cerebral Palsy and Bruxism, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate and analyze the rates and relationships between bruxism, other parafunctional oral activities, and oral-motor activities in children and adolescents with spastic CP. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cerebral Palsy, Bruxism
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2020to 13 Sep 2021
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The evaluation was made of 63 children and adolescents with spastic CP, comprising 34 (54%) females and 29 (46%) males with a mean age of 9.00±4.26 years. The GMFCS level distribution was determined at the highest rate of level 1 in 15 (23.8%) and the lowest level 5 in 9 (14.3%) children. Bruxism was present in 33 (52.4%) children, chronic mouth breathing in 33 (55.5%), sucking habits in 21 (33.3%), pacifier use for more than 24 months in 20 (31.7%), and tongue thrust in 13 (20.6%). The results of the oral-motor activity evaluation determined chewing difficulty in 35 (55.5%) children, swallowing problems in 20 (31.7%), and drooling in 23 (36.5%).
Who may be able to join
- Children and adolescents with a diagnosis of spastic CP.
- Children and adolescents ages between 3-18 years old.
Who cannot join
- Children and adolescents with a diagnosis of dyskinetic, ataxic, and/or mixed type CP
- were aged <3 years or ≥19 years,
- had severe sight or hearing impairment, or had received any orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reported Bruxism and Parafunctional Oral Habits in Children and Adolescents With Spastic Cerebral Palsy: a Cross-sectional Study
The aim of the study is to evaluate and analyze the rates and relationships between bruxism, other parafunctional oral activities, and oral-motor activities in children and adolescents with spastic CP.
Read the detailed description
This cross-sectional study was conducted on children and adolescents with CP receiving care services in three different private rehabilitation centers between January 2020 and March 2021. All the parents or primary caregivers included in the study were mothers of children with CP. Initially, information about bruxism and parafunctional oral habits and the study's aims were given to the mothers. All the mothers provided written informed consent for voluntary participation.
63 children and adolescents with spastic CP were analyzed, comprising 35 girls and 28 boys.
All the children were observed in clinical environments for classification according to the Gross Motor Function Classification System (GMFCS) and levels of activity and communication.
Data were collected from an evaluation form, clinical examination of the individuals, and interviews with the mothers.
In the first section of the evaluation, the medical records of the children with CP were reviewed for demographics, and clinical data, including age, gender, CP type, medication, and history of epilepsy. The GMFCS was used to determine the level of impairment in gross motor functions of the children.
In the second section of the evaluation, bruxism and other parafunctional oral activities were evaluated in detail through a face-to-face interview with each child's mother.
Other parafunctional oral habits were both questioned and observed in the clinical environment. The presence of sucking habits (thumb sucking, lip-biting, nail-biting, and cheek biting) and the use of a pacifier for more than 24 months was noted and recorded as present or absent.
The tongue-thrust reflex evaluation scale was applied for tongue thrust. Swallowing problems were evaluated with the water swallowing test, drooling with the saliva control problem severity, and frequency scale.
The habit of chronic breathing through the mouth was evaluated through information gained from the mother and from observation of whether nasal or buccal breaths were taken during routine treatment and evaluation in the clinical environment. For the evaluation of chewing problems, information about feeding was obtained from the mother and recorded as difficulty in chewing solid food, otherwise as absent.
- Conditions
- Cerebral Palsy, Bruxism
- Keywords
- Cerebral Palsy, Children, Adolescent, Bruxism, Habits
- Medical subject headings
- Cerebral Palsy, Bruxism, Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with CP | Children and adolescents with spastic CP are the group of the observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The GMFCS level
The GMFCS is a widely used, valid, and reliable, standardized system that classifies the impairment of gross motor functions of children with CP in 5 levels (I-II: mild; III: moderate; and IV-V: severe) based on the disabilities and level of dependence.
Measured: January 2020 and March 2021
Parental reported Bruxism
The mothers of the children in the study were given information about bruxism and parafunctional habits. They were then asked, "During the past six months, have you noticed noises of your child clenching or grinding their teeth either when awake or at least three nights a week when sleeping?". The responses were recorded as parental-reported bruxism present or absent.
Measured: January 2020 and March 2021
The Tongue Thrust Rating Scale (TTRS)
The TTRS scale evaluates the tongue's position inside the mouth in four different locations. Tongue position is expressed in figures from 0 to 3, where 0 = none (the tongue is not outside the mouth), 1=mild (tongue between the teeth), 2= moderate (tongue between the lips), and 3= severe (tongue outside the mouth).
Measured: January 2020 and March 2021
Drooling Severity and Frequency Scale
The DSFS, developed by Thomas-Stonell and Greenberg in 1988, is used to determine the level of the saliva control problem. 23 According to the information from the mothers and observation findings, drooling severity was scored from 1-5 and drooling frequency from 1-4. The severity points are interpreted as 1 = no drooling, dry lips, 2=mild, 3= moderate, 4= severe, and 5= excessive drooling wetting the clothes. The frequency points are interpreted as 1=never, 2= occasionally, 3= often, and 4=continuously.
Measured: January 2020 and March 2021
Water Swallowing Test (WST)
In this WST, the subjects in the study were seated and instructed to drink 10 ml of room temperature water. The time taken to drink all the water was recorded. Delayed swallow initiation, drooling, coughing, throat clearing, or a change in voice quality may indicate a problem. After the swallow, the patient should be observed for a minute or more to see a delayed cough response. According to the test evaluation criteria, a score of 1=normal swallowing ability, 2=a likelihood of reduced swallowing ability, and 3= reduced swallowing ability.
Measured: January 2020 and March 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start7 Jan 2020
- Primary completion1 Mar 2021
- Study completion13 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Tuncer, Hasan Kalyoncu University
- Investigators
- Aysenur Tuncer, PD, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212415
- Sponsor's protocol ID
- 2020/035
- Status last verified
- Jan 2022
- First submitted
- 16 Jan 2022
- Last updated
- 28 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reported Bruxism and Parafunctional Oral Habits in Children and Adolescents With Spastic Cerebral Palsy: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05212415
- Acronym / sponsor ID
- 2020/035
- Conditions
- Cerebral Palsy, Bruxism
- Keywords
- Cerebral Palsy, Children, Adolescent, Bruxism, Habits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 28 Jan 2022 (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 aim of the study is to evaluate and analyze the rates and relationships between bruxism, other parafunctional oral activities, and oral-motor activities in children and adolescents with spastic CP.
Detailed description
This cross-sectional study was conducted on children and adolescents with CP receiving care services in three different private rehabilitation centers between January 2020 and March 2021. All the parents or primary caregivers included in the study were mothers of children with CP. Initially, information about bruxism and parafunctional oral habits and the study's aims were given to the mothers. All the mothers provided written informed consent for voluntary participation.
63 children and adolescents with spastic CP were analyzed, comprising 35 girls and 28 boys.
All the children were observed in clinical environments for classification according to the Gross Motor Function Classification System (GMFCS) and levels of activity and communication.
Data were collected from an evaluation form, clinical examination of the individuals, and interviews with the mothers.
In the first section of the evaluation, the medical records of the children with CP were reviewed for demographics, and clinical data, including age, gender, CP type, medication, and history of epilepsy. The GMFCS was used to determine the level of impairment in gross motor functions of the children.
In the second section of the evaluation, bruxism and other parafunctional oral activities were evaluated in detail through a face-to-face interview with each child's mother.
Other parafunctional oral habits were both questioned and observed in the clinical environment. The presence of sucking habits (thumb sucking, lip-biting, nail-biting, and cheek biting) and the use of a pacifier for more than 24 months was noted and recorded as present or absent.
The tongue-thrust reflex evaluation scale was applied for tongue thrust. Swallowing problems were evaluated with the water swallowing test, drooling with the saliva control problem severity, and frequency scale.
The habit of chronic breathing through the mouth was evaluated through information gained from the mother and from observation of whether nasal or buccal breaths were taken during routine treatment and evaluation in the clinical environment. For the evaluation of chewing problems, information about feeding was obtained from the mother and recorded as difficulty in chewing solid food, otherwise as absent.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with CP | – | –Children and adolescents with spastic CP are the group of the observational study. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The evaluation was made of 63 children and adolescents with spastic CP, comprising 34 (54%) females and 29 (46%) males with a mean age of 9.00±4.26 years. The GMFCS level distribution was determined at the highest rate of level 1 in 15 (23.8%) and the lowest level 5 in 9 (14.3%) children. Bruxism was present in 33 (52.4%) children, chronic mouth breathing in 33 (55.5%), sucking habits in 21 (33.3%), pacifier use for more than 24 months in 20 (31.7%), and tongue thrust in 13 (20.6%). The results of the oral-motor activity evaluation determined chewing difficulty in 35 (55.5%) children, swallowing problems in 20 (31.7%), and drooling in 23 (36.5%).
Key inclusion criteria (2 listed)
- Children and adolescents with a diagnosis of spastic CP.
- Children and adolescents ages between 3-18 years old.
Key exclusion criteria (3 listed)
- Children and adolescents with a diagnosis of dyskinetic, ataxic, and/or mixed type CP
- were aged <3 years or ≥19 years,
- had severe sight or hearing impairment, or had received any orthodontic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The GMFCS level
Time frame: January 2020 and March 2021
The GMFCS is a widely used, valid, and reliable, standardized system that classifies the impairment of gross motor functions of children with CP in 5 levels (I-II: mild; III: moderate; and IV-V: severe) based on the disabilities and level of dependence.
Parental reported Bruxism
Time frame: January 2020 and March 2021
The mothers of the children in the study were given information about bruxism and parafunctional habits. They were then asked, "During the past six months, have you noticed noises of your child clenching or grinding their teeth either when awake or at least three nights a week when sleeping?". The responses were recorded as parental-reported bruxism present or absent.
The Tongue Thrust Rating Scale (TTRS)
Time frame: January 2020 and March 2021
The TTRS scale evaluates the tongue's position inside the mouth in four different locations. Tongue position is expressed in figures from 0 to 3, where 0 = none (the tongue is not outside the mouth), 1=mild (tongue between the teeth), 2= moderate (tongue between the lips), and 3= severe (tongue outside the mouth).
Drooling Severity and Frequency Scale
Time frame: January 2020 and March 2021
The DSFS, developed by Thomas-Stonell and Greenberg in 1988, is used to determine the level of the saliva control problem. 23 According to the information from the mothers and observation findings, drooling severity was scored from 1-5 and drooling frequency from 1-4. The severity points are interpreted as 1 = no drooling, dry lips, 2=mild, 3= moderate, 4= severe, and 5= excessive drooling wetting the clothes. The frequency points are interpreted as 1=never, 2= occasionally, 3= often, and 4=continuously.
Water Swallowing Test (WST)
Time frame: January 2020 and March 2021
In this WST, the subjects in the study were seated and instructed to drink 10 ml of room temperature water. The time taken to drink all the water was recorded. Delayed swallow initiation, drooling, coughing, throat clearing, or a change in voice quality may indicate a problem. After the swallow, the patient should be observed for a minute or more to see a delayed cough response. According to the test evaluation criteria, a score of 1=normal swallowing ability, 2=a likelihood of reduced swallowing ability, and 3= reduced swallowing ability.
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 28 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
Aysenur Tuncer, PD study director
Hasan Kalyoncu 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 Cerebral Palsy and Bruxism, run by Hasan Kalyoncu 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 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 28 Jan 2022. 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?
The GMFCS level (time frame: January 2020 and March 2021). The study lists 5 primary outcomes in all. 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 28 Jan 2022.