Evaluating chewing function in children with oral health issues
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
NA · University Hospital, Clermont-Ferrand · NCT05821140
This study is testing how chewing ability changes in children with oral health problems during treatment to see how it affects their eating habits and overall growth.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand (other) |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT05821140 on ClinicalTrials.gov |
What this trial studies
This project investigates how masticatory function evolves during oral rehabilitation in children with various oral health impairments. It focuses on parameters such as food bolus granulometry, masticatory behavior, muscle activity, and performance. The study also examines the relationship between masticatory function and factors like oral health alterations, eating behaviors, and children's growth metrics. Data collection includes clinical indicators, frequency of orofacial dysfunctions, and quality of life assessments for children and their families.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 17 years with various oral health impairments requiring dental rehabilitation.
Not a fit: Patients with no oral health issues or those not requiring any form of dental treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance oral rehabilitation strategies, leading to improved chewing function and overall quality of life for affected children.
How similar studies have performed: While similar studies have explored masticatory function, this specific approach focusing on pediatric oral rehabilitation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 1. children with multiple caries, requiring full rehabilitation under sedation or general anesthesia +/- prosthetic rehabilitation, 2. children with orofacial dysmorphologies/malocclusions, associated or not with a general syndrome, requiring orthodontic and/or prosthetic treatment 3. children with dental abnormalities, associated or not with a general syndrome, requiring conservative, orthodontic and/or prosthetic treatment, 4. 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
Where this trial is running
Clermont-Ferrand
- CHU clermont-ferrand — Clermont-Ferrand, France (RECRUITING)
Study contacts
- Principal investigator: Valérie Collado — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mastication, Disability, Oral Stage, Child Development