NCT05821140

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Mastication
• Disability
• Oral Stage
• Child Development

Interventions

Type	Name	Description
PROCEDURE	dental treatment for global oral rehabilitation	dental treatment can include conservative, orthodontic, prosthetic or surgical procedures
OTHER	oral health check up	regular preventive follow-up visit (every 6 months)

Timeline

• Start date: 2022-07-05
• Primary completion: 2031-09-01
• Completion: 2032-02-01
• First posted: 2023-04-20
• Last updated: 2023-04-20

Locations

1 site across 1 country: France