Masticatory Efficiency in Children

August 29, 2023 updated by: Odri Cicvarić, Clinical Hospital Center Rijeka

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Croatia
    • Primorsko-goranska Županija
      • Rijeka, Primorsko-goranska Županija, Croatia, 51000
        • Recruiting
        • Clinical Hospital Center Rijeka
        • Contact:
      • Rijeka, Primorsko-goranska Županija, Croatia, 51000
        • Active, not recruiting
        • Faculty of Dental Medicine of the University of Rijeka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
level of masticatory efficiency in children
Time Frame: 2 years
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
Time Frame: 2 years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
dental caries and masticatory efficiency
Time Frame: 2 years
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
Time Frame: 2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinical Hospital Center Rijeka

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Odri Cicvaric, DMD, Department of Paediatric Dentistry, Faculty of Dental Medicine of the University of Rijeka

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1111 (Other Grant/Funding Number: Prima Psychiatry internal research fund)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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