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NCT Number: NCT05821140

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

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.

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Key information

Conditions

Mastication Child Development Disability Oral Stage

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU clermont-ferrand

Clermont-Ferrand, France

Location status: Recruiting

Location contact

Lise Laclautre

CONTACT

Valérie Collado

PRINCIPAL_INVESTIGATOR

About this study

This project aims at studying the masticatory parameters and their evolution in children receiving oral rehabilitation at the special care unit (Odontology Department, CHU Estaing, Clermont-Ferrand), for different types of oral health alterations. These data could be used to support the validity of procedural guidelines in the field of functional rehabilitation in pediatric dentistry. The impact of the type of oral alteration on mastication, and the influence of the masticatory function on the quality of life, the eating habits and the height and weight status of children will also be analyzed.

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • children with multiple caries, requiring full rehabilitation under sedation or general anesthesia +/- prosthetic rehabilitation,
  • children with orofacial dysmorphologies/malocclusions, associated or not with a general syndrome, requiring orthodontic and/or prosthetic treatment
  • children with dental abnormalities, associated or not with a general syndrome, requiring conservative, orthodontic and/or prosthetic treatment,
  • 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

Treatment and study plan

dental treatment for global oral rehabilitation

Procedure

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

oral health check up

Other

regular preventive follow-up visit (every 6 months)

Primary outcomes

  1. Particle size analysis of ready to swallow natural food bolus

    Time frame: at 6 months

    Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.

  2. Particle size analysis of ready to swallow natural food bolus

    Time frame: at 12 months

    Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.

  3. Particle size analysis of ready to swallow natural food bolus

    Time frame: at 18 months

    Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.

  4. Particle size analysis of ready to swallow natural food bolus

    Time frame: at 24 months

    Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.

  5. Particle size analysis of ready to swallow natural food bolus

    Time frame: at 36 months

    Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.

  6. Particle size analysis of ready to swallow natural food bolus

    Time frame: at 48 months

    Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.

  7. Particle size analysis of ready to swallow natural food bolus

    Time frame: at 60 months

    Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.

Secondary outcomes

  1. Correlation between mastication capability, and the type of oral health alteration

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

    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

  2. Correlation between mastication behavior and the type of oral health alteration

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

    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

  3. Correlation between mastication performance and the type of oral health alteration

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

    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

  4. Correlation between muscle activity and the type of oral health alteration

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

    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

  5. Correlation between mastiaction capability and quality of life

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

    The quality of life will be assessed using questionnaires:

    • ECOHIS for children less than 6 years old
    • COHIP for children above 6 years old

    Mastication capability is evaluated by particle size analysis (D50).

  6. Correlation between mastication behavior and quality of life

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

    The quality of life will be assessed using questionnaires:

    • ECOHIS for children less than 6 years old
    • COHIP for children above 6 years old

    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)

  7. Correlation between mastication muscular activity and quality of life

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

    The quality of life will be assessed using questionnaires:

    • ECOHIS for children less than 6 years old
    • COHIP for children above 6 years old

    Muscle activity will be evaluated by measuring the electromyographic activity of masseter and temporal muscles during mastication of gelatines of various hardness.

  8. Correlation between mastication performance and quality of life

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

    The quality of life will be assessed using questionnaires:

    • ECOHIS for children less than 6 years old
    • COHIP for children above 6 years old

    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)

  9. Correlation between mastication capability and eating habits

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

    Eating habits are measured by measuring the number of food refusals and texture adaptation at home according to the 7 categories of food (PNNS)

    Mastication capability is evaluated by particle size analysis (D50).

  10. Correlation between mastication behavior and eating habits

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

    Eating habits are measured by measuring the number of food refusals and texture adaptation at home according to the 7 categories of food (PNNS)

    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)

  11. Correlation between muscular activity and eating habits

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

    Eating habits are measured by measuring the number of food refusals and texture adaptation at home according to the 7 categories of food (PNNS)

    Muscle activity will be evaluated by measuring the electromyographic activity of masseter and temporal muscles during mastication of gelatines of various hardness.

  12. Correlation between mastication performance and eating habits

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

    Eating habits are measured by measuring the number of food refusals and texture adaptation at home according to the 7 categories of food (PNNS)

    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)

  13. Correlation between mastication behavior and height and weight status

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

    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)

    Height and weight status is evaluated by calculating the BMI (body mass index) of children

  14. Correlation between muscular activity and height and weight status

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

    Muscle activity will be evaluated by measuring the electromyographic activity of masseter and temporal muscles during mastication of gelatines of various hardness.

    Height and weight status is evaluated by calculating the BMI (body mass index) of children

  15. Correlation between mastication performance and height and weight status

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

    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)

    Height and weight status is evaluated by calculating the BMI (body mass index) of children

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Centre de Recherche en Odontologie Clinique UR4847

Registry information

Official study title

Evolution of the Maturation of Orofacial Functions and of the Masticatory Function During a Rehabilitation Program, in Children With Different Types of Deterioration in Oral Health

Acronym: KIDYCROC

Important dates

Study start
2022
Primary completion
2031
Study completion
2032
First posted
Apr 20, 2023
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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