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

NCT05821140 | Recruiting

• 2 other identifiers: RBHP 2021 COLLADO2021-A00478-33
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mastication; Disability; Oral Stage; Child Development

Outcome Measures

Primary Outcomes (7)

• 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.

  at 6 months

• 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.

  at 12 months

• 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.

  at 18 months

• 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.

  at 24 months

• 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.

  at 36 months

• 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.

  at 48 months

• 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.

  at 60 months

Secondary Outcomes (15)

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

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

• Correlation between mastication behavior and the type of oral health alteration

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

• Correlation between mastication performance and the type of oral health alteration

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

• Correlation between muscle activity and the type of oral health alteration

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

• Correlation between mastiaction capability and quality of life

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

Study Arms (4)

children with ECC

EXPERIMENTAL

Children under 6 with early childhood caries receiving comprehensive dental treatment under general anesthesia

Procedure: dental treatment for global oral rehabilitation; Other: oral health check up

Children with orofacial dysmorphologies/malocclusion

EXPERIMENTAL

Children with orofacial dysmorphologies/malocclusion associated or not with a general condition and in need of a functional or orthodontic treatment

Procedure: dental treatment for global oral rehabilitation; Other: oral health check up

Children with dental abnormalities

EXPERIMENTAL

Children with dental abnormalities associated or not with a general condition and in need of conservative, orthodontic or prosthetic treatment

Procedure: dental treatment for global oral rehabilitation; Other: oral health check up

children with healthy oral state

EXPERIMENTAL

children with healthy oral state in the course of their annual follow-up visits.

Other: oral health check up

Interventions

dental treatment for global oral rehabilitation PROCEDURE

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

Children with dental abnormalities; Children with orofacial dysmorphologies/malocclusion; children with ECC

oral health check up OTHER

regular preventive follow-up visit (every 6 months)

Children with dental abnormalities; Children with orofacial dysmorphologies/malocclusion; children with ECC; children with healthy oral state

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Centre de Recherche en Odontologie Clinique UR4847: collaborator

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Interventions

Dental Care

Intervention Hierarchy (Ancestors)

Dentistry; Dental Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Valérie Collado

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: April 20, 2023
• Study Start: July 5, 2022
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): February 1, 2032
• Last Updated: April 20, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)