NCT05821140 Orofacial Functions and Masticatory Function in Children With Different Types of Deterioration in Oral Health
| NCT ID | NCT05821140 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Mastication |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2022-07-05 |
| Primary Completion | 2031-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 112 participants in total. It began in 2022-07-05 with a primary completion date of 2031-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Valérie Collado
PRINCIPAL INVESTIGATOR
University Hospital, Clermont-Ferrand
Frequently Asked Questions
Who can join the NCT05821140 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Mastication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05821140 currently recruiting?
Yes, NCT05821140 is actively recruiting participants. Contact the research team at promo_interne_drci@chu-clermontferrand.fr for enrollment information.
Where is the NCT05821140 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France.
Who is sponsoring the NCT05821140 clinical trial?
NCT05821140 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Valérie Collado at University Hospital, Clermont-Ferrand. The trial plans to enroll 112 participants.