- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05212415
Bruxism and Parafunctional Oral Habits in Children and Adolescents With Cerebral Palsy
Reported Bruxism and Parafunctional Oral Habits in Children and Adolescents With Spastic Cerebral Palsy: a Cross-sectional Study
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gaziantep, Turkey
- Hasan Kalyoncu University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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%).
Description
Inclusion Criteria:
- Children and adolescents with a diagnosis of spastic CP.
- Children and adolescents ages between 3-18 years old.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Children with CP
Children and adolescents with spastic CP are the group of the observational study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The GMFCS level
Time Frame: January 2020 and March 2021
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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.
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January 2020 and March 2021
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Parental reported Bruxism
Time Frame: January 2020 and March 2021
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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.
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January 2020 and March 2021
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The Tongue Thrust Rating Scale (TTRS)
Time Frame: January 2020 and March 2021
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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).
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January 2020 and March 2021
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Drooling Severity and Frequency Scale
Time Frame: January 2020 and March 2021
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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.
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January 2020 and March 2021
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Water Swallowing Test (WST)
Time Frame: January 2020 and March 2021
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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.
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January 2020 and March 2021
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Aysenur Tuncer, PD, Hasan Kalyoncu University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/035
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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