Bruxism and Parafunctional Oral Habits in Children and Adolescents With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Reported Bruxism and Parafunctional Oral Habits in Children and Adolescents With Spastic Cerebral Palsy: a Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05212415
• Other study ID #: 2020/035
• Status: Completed
• Start date: January 7, 2020
• Est. completion date: September 13, 2021

Study information

• Verified date: January 2022
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 13, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bruxism
• Cerebral Palsy
• Paralysis

Locations

Country	Name	City	State
Turkey	Hasan Kalyoncu University	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	January 2020 and March 2021
Primary	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.	January 2020 and March 2021
Primary	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).	January 2020 and March 2021
Primary	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.	January 2020 and March 2021
Primary	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.	January 2020 and March 2021