Orofacial Functions and Masticatory Function in Children With Different Types of Deterioration in Oral Health
NCT ID: NCT05821140
Last Updated: 2023-04-20
Study Results
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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RECRUITING
NA
112 participants
INTERVENTIONAL
2022-07-05
2032-02-29
Brief Summary
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Secondary objectives are to study the relationships between children masticatory function (food bolus granulometry, masticatory behavior, muscle activity and masticatory performance) and its evolution during oral rehabilitation, and:
* their type of oral health alteration
* their eating behaviors
* their height and weight status
During examination the following parameters are collected:
* Various clinical indicators of oral health
* The child's weight and height
* Frequency and nature of orofacial dysfunctions
* The oral health related quality of life of children and their families
* Chewing tests are performed (chewing gum, natural food such as carrot, cereals, and cheese samples, samples of gelatins of different hardness)
Examination and differents tests are performed every six months for a total of 5 years (per participant)
The dental care procedures performed during the study were carried out in the usual way.
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Detailed Description
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The main objective is to study the evolution of masticatory function (food bolus granulometry, behavior, muscle activity and performance) during a rehabilitation program, in children with different types of oral health impairment.
Secondary objectives are to study the relationships between children masticatory function (food bolus granulometry, masticatory behavior, muscle activity and masticatory performance) and its evolution during oral rehabilitation, and:
* their type of oral health alteration
* their eating behaviors
* their height and weight status
This is a follow-up study using criteria from clinical orofacial examination, questionnaires, video recordings of natural food chewing sequences and analysis of food bolus.
Indeed, objective and non-invasive indicators of oro-facial functions and mastication are recorded as part of the usual follow-up of children (according to the recommendations of the American Association of Pediatric Dentistry 2020) during observations (live or on video recordings outside the presence of the family) or interviews with the child and his/her parents (questionnaires), or following masticatory tests.
During children examination, and after questionnaires are completed with the parents or the child himself, these data are collected:
* Various clinical indicators of oral health (caod/CAOD; PUFA; ICDAS)
* The child's weight and height for the calculation of the Body Mass Index (BMI) as a clinical indicator of the child's growth
* Frequency of orofacial dysfunctions (NOT-S test)
* The impact of oral health on the quality of life of children and their families (ECOHIS or COHIP tests depending on age)
The following parameters are collected from chewing tests:
* Children's chewing behavior described by the family (feeding behaviors) or observed during the visit (clinical index of "quality of muscle function during chewing") or determined outside the presence of the family from video recordings made during the visit while chewing test foods (chewing kinematic parameters).
* Granulometry of natural food boluses (D50: median particle size of food boluses)
* A chewing performance measured by the heterogeneity of a two-colored chewing gum after chewing for a defined number of cycles.
* The muscular activity during mastication of samples of gelatins of different hardness, carried out with recording of the masseter and temporal muscles activity (EMG)
The dental care procedures performed during the study were carried out in the usual way.
Examination and differents tests are performed every six months for a total of 5 years (per participant).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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children with ECC
Children under 6 with early childhood caries receiving comprehensive dental treatment under general anesthesia
dental treatment for global oral rehabilitation
dental treatment can include conservative, orthodontic, prosthetic or surgical procedures
oral health check up
regular preventive follow-up visit (every 6 months)
Children with orofacial dysmorphologies/malocclusion
Children with orofacial dysmorphologies/malocclusion associated or not with a general condition and in need of a functional or orthodontic treatment
dental treatment for global oral rehabilitation
dental treatment can include conservative, orthodontic, prosthetic or surgical procedures
oral health check up
regular preventive follow-up visit (every 6 months)
Children with dental abnormalities
Children with dental abnormalities associated or not with a general condition and in need of conservative, orthodontic or prosthetic treatment
dental treatment for global oral rehabilitation
dental treatment can include conservative, orthodontic, prosthetic or surgical procedures
oral health check up
regular preventive follow-up visit (every 6 months)
children with healthy oral state
children with healthy oral state in the course of their annual follow-up visits.
oral health check up
regular preventive follow-up visit (every 6 months)
Interventions
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dental treatment for global oral rehabilitation
dental treatment can include conservative, orthodontic, prosthetic or surgical procedures
oral health check up
regular preventive follow-up visit (every 6 months)
Eligibility Criteria
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Inclusion Criteria
* Children and adolescents who have given their consent (6-17 years) and whose legal guardians have given their consent.
* Children (3-6 years old) with consent from the legal guardian.
* The subject is affiliated with a Social Security system.
This may include:
1. children with multiple caries, requiring full rehabilitation under sedation or general anesthesia +/- prosthetic rehabilitation,
2. children with orofacial dysmorphologies/malocclusions, associated or not with a general syndrome, requiring orthodontic and/or prosthetic treatment
3. children with dental abnormalities, associated or not with a general syndrome, requiring conservative, orthodontic and/or prosthetic treatment,
4. children with a healthy oral status in the course of their bi-annual oral health chek-up.
Exclusion Criteria
* Children who do not have a solid diet due to severe neuromotor disorders.
* Children for whom a geographical or organizational barrier prevents follow-up in the service, children in social placement
* Children over 18 years of age
* Children (6-17 years) who do not volunteer to participate
* Children (6-17 years old) who are unable to give consent to participate in the research.
* Children for whom one of the legal guardians refuses to participate in the study
* Children whose legal guardians are not capable of giving informed consent.
* Children who are not affiliated to a Social Security system.
* Pregnant or nursing teenagers
3 Years
17 Years
ALL
No
Sponsors
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Centre de Recherche en Odontologie Clinique UR4847
UNKNOWN
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Valérie Collado
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU clermont-ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Lise Laclautre
Role: primary
Other Identifiers
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2021-A00478-33
Identifier Type: OTHER
Identifier Source: secondary_id
RBHP 2021 COLLADO
Identifier Type: -
Identifier Source: org_study_id
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