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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Particle size analysis of ready to swallow natural food bolus
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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.
排除标准
- •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
结局指标
主要结局
Particle size analysis of ready to swallow natural food bolus
时间窗: at 60 months
Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
次要结局
- 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 mastication performance and quality of life(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 mastication capability and eating habits(every 6 months for 1year, and then each year for 4 years)
- Correlation between muscular activity and eating habits(every 6 months for 1year, and then each year for 4 years)
- Correlation between muscular activity and height and weight status(every 6 months for 1year, and then each year for 4 years)
- 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 mastiaction capability and quality of life(every 6 months for 1year, and then each year for 4 years)
- Correlation between mastication behavior and quality of life(every 6 months for 1year, and then each year for 4 years)
- Correlation between mastication muscular activity and quality of life(every 6 months for 1year, and then each year for 4 years)
- Correlation between mastication behavior and eating habits(every 6 months for 1year, and then each year for 4 years)
- Correlation between mastication performance and height and weight status(every 6 months for 1year, and then each year for 4 years)
- Correlation between mastication performance and eating habits(every 6 months for 1year, and then each year for 4 years)
- Correlation between mastication behavior and height and weight status(every 6 months for 1year, and then each year for 4 years)