Mastication DisorderNCT05000385
Masticatory Efficiency in Children
An observational study of Mastication Disorder, run by Clinical Hospital Center Rijeka at 2 sites in Croatia.
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. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Mastication Disorder
- What is being tested?
- Assesment of masticatory efficiency with optical scanning method and body mass index
- Type of treatment
- Pill or oral medicine
- How many people
- 96 participants
- Where
- 2 sitesCroatia
- Study dates
- 1 May 2021to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Croatia2 sites, 1 recruiting
- Recruiting
Clinical Hospital Center Rijeka
Rijeka, Primorje-Gorski Kotar County, 51000
prof.prim.dr.sc. Danko Bakarcic, DMD, 0038551345640, danko.bakarcic@fdmri.uniri.hr
- Active, not recruiting
Faculty of Dental Medicine of the University of Rijeka
Rijeka, Primorje-Gorski Kotar County, 51000
About this study
Official title: 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.
- Conditions
- Mastication Disorder
- Being tested
- Assesment of masticatory efficiency with optical scanning method, body mass index
- Keywords
- Body Mass Index, Child, Mastication, Stomatognathic Diseases, Particle size
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assesment of masticatory efficiency with optical scanning methodOther
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 indexDiagnostic test
as an indication of nutritional status
| Study group | Role | What they receive |
|---|---|---|
| Healthy | healthy complete dentition Receives: 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) Receives: 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 Receives: 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 Receives: Other: Assesment of masticatory efficiency with optical scanning method; Diagnostic Test: body mass index |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 2 years
Secondary outcomes (2)
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
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 May 2021
- Primary completion1 May 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastication DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Center Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Odri Cicvarić, Clinical Hospital Center Rijeka
- Investigators
- Odri Cicvaric, DMD, Principal investigator, Department of Paediatric Dentistry, Faculty of Dental Medicine of the University of Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000385
- Sponsor's protocol ID
- 1111
- Status last verified
- Aug 2023
- First submitted
- 22 Jul 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Masticatory Efficiency With the Condition of the Stomatognathic System in Children
- ClinicalTrials.gov ID
- NCT05000385
- Acronym / sponsor ID
- 1111
- Conditions
- Mastication Disorder
- Keywords
- Body Mass Index, Child, Mastication, Stomatognathic Diseases, Particle size
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Clinical Hospital Center RijekaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Other: Assesment of masticatory efficiency with optical scanning method, Diagnostic Test: body mass indexhealthy complete dentition |
| Dental caries | – | Other: Assesment of masticatory efficiency with optical scanning method, Diagnostic Test: body mass indexcomplete dentition with bilateral dental caries (ICDAS 4,5 or 6) |
| Occlusal contacts | – | Other: Assesment of masticatory efficiency with optical scanning method, Diagnostic Test: body mass indexocclusal contacts are lost bilaterally due to extraction, changing dentition or orthodontic anomalies; no dental caries |
| Dentures | – | Other: Assesment of masticatory efficiency with optical scanning method, Diagnostic Test: body mass indexpatients with dentures, no caries and/or missing occlusal contacts on remaining teeth |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (7 listed)
- children of both genders aged 3 to 14, with:
- signed informed consent by participant's parents
- verbal consent of the children
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assesment of masticatory efficiency with optical scanning methodParticipants 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. | Other | Dental caries, Dentures, Healthy, Occlusal contacts |
| body mass indexas an indication of nutritional status | Diagnostic test | Dental caries, Dentures, Healthy, Occlusal contacts |
Primary outcome
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
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 secondary outcomes
dental caries and masticatory efficiency
Time frame: 2 years
occlusal contact and masticatory efficiency
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odri Cicvaric, DMD principal investigator
Department of Paediatric Dentistry, Faculty of Dental Medicine of the University of Rijeka
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mastication Disorder, run by Clinical Hospital Center Rijeka at 2 sites in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Odri Cicvaric, DMD (0038551345636, odri.cicvaric@fdmri.uniri.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of masticatory efficiency in children (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.