Clinical trial NCT05212415: Bruxism and Parafunctional Oral Habits in Children and Adolescents With Cerebral Palsy
Official title: Reported Bruxism and Parafunctional Oral Habits in Children and Adolescents With Spastic Cerebral Palsy: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Bruxism
Keywords: Cerebral Palsy
Children
Adolescent
Bruxism
Habits
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 63
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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%).

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The GMFCS level
timeFrame: January 2020 and March 2021
measure: Parental reported Bruxism
timeFrame: January 2020 and March 2021
measure: The Tongue Thrust Rating Scale (TTRS)
timeFrame: January 2020 and March 2021
measure: Drooling Severity and Frequency Scale
timeFrame: January 2020 and March 2021
measure: Water Swallowing Test (WST)
timeFrame: January 2020 and March 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
affiliation: Hasan Kalyoncu University
name: Aysenur Tuncer, PD
role: STUDY_DIRECTOR
References: