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NCT05000385 Clinical Trial

Masticatory Efficiency in Children

Mastication Disorder Clinical Trial

Official title:
Association of Masticatory Efficiency With the Condition of the Stomatognathic System in Children

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05000385
Other study ID # 1111
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date December 1, 2024

Study information
Verified date August 2023
Source Clinical Hospital Center Rijeka
Contact Odri Cicvaric, DMD
Phone 0038551345636
Email odri.cicvaric@fdmri.uniri.hr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 96
Est. completion date December 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 3 Years to 14 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Croatia Clinical Hospital Center Rijeka Rijeka Primorsko-goranska Županija
Croatia Faculty of Dental Medicine of the University of Rijeka Rijeka Primorsko-goranska Županija

Sponsors (1)
Lead Sponsor Collaborator
Clinical Hospital Center Rijeka

Country where clinical trial is conducted

Croatia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
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