Clinical trial NCT05000385: Masticatory Efficiency in Children
Official title: Association of Masticatory Efficiency With the Condition of the Stomatognathic System in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mastication Disorder
Keywords: Body Mass Index
Child
Mastication
Stomatognathic Diseases
Particle size
Lead sponsor: Clinical Hospital Center Rijeka
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 96
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children of both genders aged 3 to 14, with: full healthy dentition, bilateral dental caries stage 4,5 or 6 by ICDAS criteria, reduced number of occlusal contacts, and dentures, that are coming to Department of Paediatric Dentistry of Dental Clinic of the Clinical Hospital Center Rijeka for examination and/or therapy.

Brief summary: This study aims to evaluate the association of masticatory efficiency with different conditions of the stomatognathic system (transitioning from primary to secondary dentition, dental caries, malocclusion, tooth loss, prosthodontic treatment) in the paediatric population. Also, to assess the correlation between masticatory efficiency and nutritional status. The study will be conducted on children between 3 and 14 years of age. Masticatory efficiency will be evaluated by the optical scanning method. Participants will chew a standardized silicone tablet controlled by the examiner for 20 masticatory strokes. By scanning the comminuted particles, data on each particle's size will be obtained. Enhanced masticatory performance is presented by a decrease in the chewed particle areas and an increase in the number of chewed particles.


Eligibility criteria: Inclusion Criteria:

* children of both genders aged 3 to 14, with:

  * full healthy dentition
  * bilateral dental caries stage 4,5 or 6 by ICDAS criteria
  * reduced number of occlusal contacts
  * dentures
* signed informed consent by participant's parents
* verbal consent of the children

Exclusion Criteria:

* uncooperative behavior
* symptoms of temporomandibular joint dysfunction
* parafunctional habits
* systemic disturbances that can impact mastication
* ingestion of medicines that could interfere directly or indirectly with muscular activity
* tooth anomalies of structure, number or form
* periodontal disease
* tooth mobility

Primary outcomes:
measure: level of masticatory efficiency in children
timeFrame: 2 years
measure: masticatory efficiency and body mass index
timeFrame: 2 years
Secondary outcomes:
measure: dental caries and masticatory efficiency
timeFrame: 2 years
measure: occlusal contact and masticatory efficiency
timeFrame: 2 years
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: Clinical Hospital Center Rijeka
state: Primorsko-goranska Županija
city: Rijeka
country: Croatia
facility: Faculty of Dental Medicine of the University of Rijeka
state: Primorsko-goranska Županija
Study officials:
affiliation: Department of Paediatric Dentistry, Faculty of Dental Medicine of the University of Rijeka
name: Odri Cicvaric, DMD
role: PRINCIPAL_INVESTIGATOR
References: