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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-17
SponsorUniversity Hospital, Clermont-Ferrand

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • dental treatment for global oral rehabilitation

    Procedure/Surgery

    dental treatment can include conservative, orthodontic, prosthetic or surgical procedures

  • oral health check up

    Other intervention

    regular preventive follow-up visit (every 6 months)

Treatment groups

112 Participants
are divided into 4 treatment groups
Group A: children with ECCExperimental treatment 2 interventions
Group B: Children with orofacial dysmorphologies/malocclusionExperimental treatment 2 interventions
Group C: Children with dental abnormalitiesExperimental treatment 2 interventions
Group D: children with healthy oral stateExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
at 6 months
2

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.

Time frame
at 12 months
3

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.

Time frame
at 18 months
4

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.

Time frame
at 24 months

Secondary outcomes

1

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

Time frame
every 6 months for 1year, and then each year for 4 years
2

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

Time frame
every 6 months for 1year, and then each year for 4 years
3

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

Time frame
every 6 months for 1year, and then each year for 4 years
4

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

Time frame
every 6 months for 1year, and then each year for 4 years

Other outcomes

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