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Clinical Trials in France / NCT05821140
Recruiting Not applicable

Orofacial Functions and Masticatory Function in Children With Different Types of Deterioration in Oral Health

NCT05821140 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Clermont-Ferrand
Phase
Not applicable
Started
2022-07-05
Last updated
2023-04-20

Condition(s) studied

MasticationDisabilityOral StageChild Development

Investigational drug(s) / intervention(s)

dental treatment for global oral rehabilitationoral health check up

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)

Study summary

This project aims at studying the evolution of masticatory function (food bolus granulometry, masticatory behavior, muscle activity and masticatory performance) during oral rehabilitation, 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

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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * All children, from 3 to 17 years old (inclusion limits), attending the special dental care unit of the CHU Estaing in Clermont Ferrand or the CH Guy Thomas in Riom are included in the study: * 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 with an ASA III or IV category according to the American Society of Anesthesiologists * 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

Primary outcome measure(s)

  • Particle size analysis of ready to swallow natural food bolus — at 6 months
    Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
  • Particle size analysis of ready to swallow natural food bolus — at 12 months
    Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
  • Particle size analysis of ready to swallow natural food bolus — at 18 months
    Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
  • Particle size analysis of ready to swallow natural food bolus — at 24 months
    Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
  • Particle size analysis of ready to swallow natural food bolus — at 36 months
    Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
  • Particle size analysis of ready to swallow natural food bolus — at 48 months
    Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
  • Particle size analysis of ready to swallow natural food bolus — at 60 months
    Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.

Trial sites (1)

FacilityCityRegionStatus
CHU clermont-ferrand Clermont-Ferrand France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05821140 on ClinicalTrials.gov ↗ ← All trials in France