Masticatory Efficiency in Children

NCT05000385 | Unknown

• 1 other identifier: 1111
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 2

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.

Conditions

Mastication Disorder

Keywords

Body Mass Index; Child; Mastication; Stomatognathic Diseases; Particle size

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• dental caries and masticatory efficiency

  2 years

• occlusal contact and masticatory efficiency

  2 years

Study Arms (4)

Healthy

healthy complete dentition

Other: Assesment of masticatory efficiency with optical scanning method; Diagnostic Test: body mass index

Dental caries

complete dentition with bilateral dental caries (ICDAS 4,5 or 6)

Other: Assesment of masticatory efficiency with optical scanning method; Diagnostic Test: body mass index

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; Diagnostic Test: body mass index

Dentures

patients with dentures, no caries and/or missing occlusal contacts on remaining teeth

Other: Assesment of masticatory efficiency with optical scanning method; Diagnostic Test: body mass index

Interventions

Assesment of masticatory efficiency with optical scanning method OTHER

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.

Dental caries; Dentures; Healthy; Occlusal contacts

body mass index DIAGNOSTIC_TEST

as an indication of nutritional status

Dental caries; Dentures; Healthy; Occlusal contacts

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Center Rijeka: lead

Study Sites (2)

Clinical Hospital Center Rijeka

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

RECRUITING

Faculty of Dental Medicine of the University of Rijeka

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Stomatognathic Diseases

Interventions

Body Mass Index

Intervention Hierarchy (Ancestors)

Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Odri Cicvaric, DMD

  Department of Paediatric Dentistry, Faculty of Dental Medicine of the University of Rijeka

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Odri Cicvaric, DMD

CONTACT

0038551345636; odri.cicvaric@fdmri.uniri.hr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DMD, Principal Investigator

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 11, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

CR (2)