Actively Recruiting

Phase Not Applicable
Age: 3Years - 17Years
All Genders
ID05821140

Evolution of Orofacial and Masticatory Function During Rehabilitation in Children with Various Oral Health Conditions

Led by University Hospital, Clermont-Ferrand · Updated on 2023-04-20

112

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Clermont-Ferrand

Lead Sponsor

C

Centre de Recherche en Odontologie Clinique UR4847

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how chewing function changes during oral rehabilitation in children aged 3 to 17 with different types of oral health problems. The study aims to understand how chewing ability, muscle activity, and behavior evolve, and how these relate to oral health issues, eating habits, and children's height and weight. This research is conducted at a special care dental unit and focuses on improving guidelines for pediatric dental rehabilitation. Children in the study receive dental treatments such as conservative care, orthodontics, prosthetics, or surgery as part of their usual care. They are grouped based on their oral health condition: early childhood caries treated under anesthesia, orofacial dysmorphologies needing orthodontic or functional treatment, dental abnormalities requiring various dental procedures, and those with healthy oral status during routine check-ups. These treatments and follow-ups occur regularly every six months over a five-year period. Participants undergo examinations every six months that include clinical oral health checks, weight and height measurements, and assessments of orofacial function and quality of life through questionnaires. Chewing tests with different foods and muscle activity recordings are performed to evaluate chewing performance. Researchers analyze particle size of chewed food and correlate chewing parameters with oral health, quality of life, eating behavior, and growth over time. The total participation lasts five years per child.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 3Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 3 to 17 years attending the special dental care units involved in the study
  • Consent given by children aged 6-17 and their legal guardians, or by legal guardians for children aged 3-6
  • Participants must be affiliated with a Social Security system
  • Includes children with multiple caries requiring dental rehabilitation under anesthesia
  • Includes children with orofacial dysmorphologies or malocclusions needing orthodontic or prosthetic treatment
  • Includes children with dental abnormalities requiring conservative, orthodontic, or prosthetic treatment
  • Includes children with healthy oral status attending routine bi-annual dental check-ups
Not Eligible

You will not qualify if you...

  • Children classified as ASA III or IV according to the American Society of Anesthesiologists
  • Children unable to eat a solid diet due to severe neuromotor disorders
  • Children with geographic or organizational barriers preventing follow-up
  • Children over 18 years old
  • Children aged 6-17 who do not volunteer or cannot give consent
  • Children whose legal guardians refuse consent or cannot provide informed consent
  • Children not affiliated with a Social Security system
  • Pregnant or nursing teenagers

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Ongoing during the rehabilitation program lasting up to 5 years

Participants receive dental treatment for global oral rehabilitation, which may include conservative, orthodontic, prosthetic, or surgical procedures to improve oral health.

Visits every 6 months for up to 5 years

Monitoring

Duration - 6 months to 5 years

Participants are observed through clinical examinations, questionnaires, video recordings of chewing, and tests of masticatory function to assess the evolution of oral and masticatory function during and after rehabilitation.

Visits every 6 months for up to 5 years

Trial Site Locations

Total: 1 location

1

CHU clermont-ferrand

Clermont-Ferrand, France

Actively Recruiting

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Research Team

L

Lise Laclautre

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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