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

Sponsor
Hasan Kalyoncu University (Other)
Overall Status
Completed
CT.gov ID
NCT05212415
Collaborator
(none)
63
1
20.2
3.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    63 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Reported Bruxism and Parafunctional Oral Habits in Children and Adolescents With Spastic Cerebral Palsy: a Cross-sectional Study
    Actual Study Start Date :
    Jan 7, 2020
    Actual Primary Completion Date :
    Mar 1, 2021
    Actual Study Completion Date :
    Sep 13, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Children with CP

    Children and adolescents with spastic CP are the group of the observational study.

    Outcome Measures

    Primary Outcome Measures

    1. The GMFCS level [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.

    2. Parental reported Bruxism [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.

    3. The Tongue Thrust Rating Scale (TTRS) [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).

    4. Drooling Severity and Frequency Scale [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.

    5. Water Swallowing Test (WST) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hasan Kalyoncu University Gaziantep Turkey

    Sponsors and Collaborators

    • Hasan Kalyoncu University

    Investigators

    • Study Director: Aysenur Tuncer, PD, Hasan Kalyoncu University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aysenur Tuncer, PT, PhD, Hasan Kalyoncu University
    ClinicalTrials.gov Identifier:
    NCT05212415
    Other Study ID Numbers:
    • 2020/035
    First Posted:
    Jan 28, 2022
    Last Update Posted:
    Jan 28, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Aysenur Tuncer, PT, PhD, Hasan Kalyoncu University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 28, 2022