About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
children with multiple caries, requiring full rehabilitation under sedation or general anesthesia +/- prosthetic rehabilitation,
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
dental treatment for global oral rehabilitation
Procedure/Surgerydental treatment can include conservative, orthodontic, prosthetic or surgical procedures
oral health check up
Other interventionregular preventive follow-up visit (every 6 months)
Treatment groups
Trial outcomes
Primary outcomes
Particle size analysis of ready to swallow natural food bolus
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
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
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
Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
Secondary outcomes
Correlation between mastication capability, and the type of oral health alteration
Mastication capability is evaluated by particle size analysis (D50). The type of oral health alterations are defined by * presence of multiple caries * oro facial dysmorphologies * dental abnormalities * health oral state
Correlation between mastication behavior and the type of oral health alteration
Mastication behavior is measured by measuring the number of food refusals during mastication tests, measuring the kinematic parameters (number of cycle (nc), mastication time (T) to calculate the masticatory frequency (nc/T) The type of oral health alterations are defined by * presence of multiple caries * oro facial dysmorphologies * dental abnormalities * health oral state
Correlation between mastication performance and the type of oral health alteration
Mastication performance is evaluated by measuring the heterogeneity of the color of a bicolor chewing gum masticated during a given number of cycles (chewgum test) (Hue standard deviation) The type of oral health alterations are defined by * presence of multiple caries * oro facial dysmorphologies * dental abnormalities * health oral state
Correlation between muscle activity and the type of oral health alteration
Muscle activity will be evaluated by measuring the electromyographic activity of masseter and temporal muscles during mastication of gelatines of various hardness. The type of oral health alterations are defined by * presence of multiple caries * oro facial dysmorphologies * dental abnormalities * health oral state
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Clermont-Ferrand
Lead sponsor
Centre de Recherche en Odontologie Clinique UR4847
Collaborator