Masticatory Efficiency in Children

Association of Masticatory Efficiency With the Condition of the Stomatognathic System in Children

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.

Study Overview

• Status: Recruiting
• Conditions: Mastication Disorder
• Intervention / Treatment: Other: Assesment of masticatory efficiency with optical scanning method; Diagnostic test: body mass index

• Study Type: Observational
• Enrollment (Estimated): 96

Contacts and Locations

• Study Contact: Name: Odri Cicvaric, DMD; Phone Number: 0038551345636; Email: odri.cicvaric@fdmri.uniri.hr

Study Locations

• Croatia
  • Primorsko-goranska Županija
    • Rijeka, Primorsko-goranska Županija, Croatia, 51000
      • Recruiting
      • Clinical Hospital Center Rijeka
      • Contact: prof.prim.dr.sc. Danko Bakarcic, DMD; Phone Number: 0038551345640; Email: danko.bakarcic@fdmri.uniri.hr
    • Rijeka, Primorsko-goranska Županija, Croatia, 51000
      • Active, not recruiting
      • Faculty of Dental Medicine of the University of Rijeka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 14 years (Child)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy; healthy complete dentition	Other: Assesment of masticatory efficiency with 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 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.; Diagnostic test: body mass index; as an indication of nutritional status
Dental caries; complete dentition with bilateral dental caries (ICDAS 4,5 or 6)	Other: Assesment of masticatory efficiency with 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 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.; Diagnostic test: body mass index; as an indication of nutritional status
Occlusal contacts; occlusal contacts are lost bilaterally due to extraction, changing dentition or orthodontic anomalies; no dental caries	Other: Assesment of masticatory efficiency with 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 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.; Diagnostic test: body mass index; as an indication of nutritional status
Dentures; patients with dentures, no caries and/or missing occlusal contacts on remaining teeth	Other: Assesment of masticatory efficiency with 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 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.; Diagnostic test: body mass index; as an indication of nutritional status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of masticatory efficiency in children	determining the masticator efficiency variable (mean area of chewed particles) with optical scanning method, data comparison between four groups	2 years
masticatory efficiency and body mass index	determining the correlation of the masticatory efficiency variable (mean area of chewed particles determined by the optical scanning method) with body mass index (weight and height will be combined to report BMI in kg/m^2)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dental caries and masticatory efficiency	determining the correlation of the masticatory efficiency (mean area of chewed particles determined by the optical scanning method) with the number of dental caries	2 years
occlusal contact and masticatory efficiency	determining the correlation of the masticatory efficiency (mean area of chewed particles determined by the optical scanning method) with the number of lost occlusal contacts	2 years

Collaborators and Investigators

• Sponsor: Clinical Hospital Center Rijeka
• Investigators: Principal Investigator: Odri Cicvaric, DMD, Department of Paediatric Dentistry, Faculty of Dental Medicine of the University of Rijeka

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Child; Body Mass Index; Stomatognathic Diseases; Mastication; Particle size
• Other Study ID Numbers: 1111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No