Masticatory Efficiency in Children

NCT ID: NCT05000385

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Mastication Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy

healthy complete dentition

Assesment of masticatory efficiency with optical scanning method

Intervention Type 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.

body mass index

Intervention Type DIAGNOSTIC_TEST

as an indication of nutritional status

Dental caries

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

Assesment of masticatory efficiency with optical scanning method

Intervention Type 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.

body mass index

Intervention Type DIAGNOSTIC_TEST

as an indication of nutritional status

Occlusal contacts

occlusal contacts are lost bilaterally due to extraction, changing dentition or orthodontic anomalies; no dental caries

Assesment of masticatory efficiency with optical scanning method

Intervention Type 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.

body mass index

Intervention Type DIAGNOSTIC_TEST

as an indication of nutritional status

Dentures

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

Assesment of masticatory efficiency with optical scanning method

Intervention Type 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.

body mass index

Intervention Type DIAGNOSTIC_TEST

as an indication of nutritional status

Interventions

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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.

Intervention Type OTHER

body mass index

as an indication of nutritional status

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Hospital Center Rijeka

OTHER

Sponsor Role lead

Responsible Party

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Odri Cicvarić

DMD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Odri Cicvaric, DMD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Clinical Hospital Center Rijeka

Rijeka, Primorje-Gorski Kotar County, Croatia

Site Status RECRUITING

Faculty of Dental Medicine of the University of Rijeka

Rijeka, Primorje-Gorski Kotar County, Croatia

Site Status ACTIVE_NOT_RECRUITING

Countries

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Croatia

Central Contacts

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Odri Cicvaric, DMD

Role: CONTACT

0038551345636

Facility Contacts

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prof.prim.dr.sc. Danko Bakarcic, DMD

Role: primary

0038551345640

Other Identifiers

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1111

Identifier Type: -

Identifier Source: org_study_id

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