MasticationKIDYCROCNCT05821140
Orofacial Functions and Masticatory Function in Children With Different Types of Deterioration in Oral Health
A study testing dental treatment for global oral rehabilitation and oral health check up in people with Mastication and Disability, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Mastication, Disability, Oral Stage
- What is being tested?
- dental treatment for global oral rehabilitation and oral health check up
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jul 2022to Feb 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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,
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU clermont-ferrand
Clermont-Ferrand
Lise Laclautre
Valérie Collado
About this study
Official title: 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
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:
Read more
- 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.
Read the 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
- Being tested
- dental treatment for global oral rehabilitation, oral health check up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental treatment for global oral rehabilitationProcedure or surgery
dental treatment can include conservative, orthodontic, prosthetic or surgical procedures
oral health check upOther
regular preventive follow-up visit (every 6 months)
| Study group | Role | What they receive |
|---|---|---|
| children with ECC | Experimental | Children under 6 with early childhood caries receiving comprehensive dental treatment under general anesthesia Receives: Procedure: dental treatment for global oral rehabilitation; Other: oral health check up |
| Children with orofacial dysmorphologies/malocclusion | Experimental | Children with orofacial dysmorphologies/malocclusion associated or not with a general condition and in need of a functional or orthodontic treatment Receives: Procedure: dental treatment for global oral rehabilitation; Other: oral health check up |
| Children with dental abnormalities | Experimental | Children with dental abnormalities associated or not with a general condition and in need of conservative, orthodontic or prosthetic treatment Receives: Procedure: dental treatment for global oral rehabilitation; Other: oral health check up |
| children with healthy oral state | Experimental | children with healthy oral state in the course of their annual follow-up visits. Receives: Other: oral health check up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Particle size analysis of ready to swallow natural food bolus
Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
Measured: at 6 months
Particle size analysis of ready to swallow natural food bolus
Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
Measured: at 12 months
Particle size analysis of ready to swallow natural food bolus
Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
Measured: at 18 months
Particle size analysis of ready to swallow natural food bolus
Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
Measured: at 24 months
Particle size analysis of ready to swallow natural food bolus
Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
Measured: at 36 months
Particle size analysis of ready to swallow natural food bolus
Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
Measured: at 48 months
Particle size analysis of ready to swallow natural food bolus
Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
Measured: at 60 months
Secondary outcomes (15)
Correlation between mastication capability, and the type of oral health alteration
Mastication capability is evaluated by particle size analysis (D50).
The type of oral health alterations are defined by
- presence of multiple caries
- oro facial dysmorphologies
- dental abnormalities
- health oral state
Measured: every 6 months for 1year, and then each year for 4 years
Correlation between mastication behavior and the type of oral health alteration
Mastication behavior is measured by measuring the number of food refusals during mastication tests, measuring the kinematic parameters (number of cycle (nc), mastication time (T) to calculate the masticatory frequency (nc/T)
The type of oral health alterations are defined by
- presence of multiple caries
- oro facial dysmorphologies
- dental abnormalities
- health oral state
Measured: every 6 months for 1year, and then each year for 4 years
Correlation between mastication performance and the type of oral health alteration
Mastication performance is evaluated by measuring the heterogeneity of the color of a bicolor chewing gum masticated during a given number of cycles (chewgum test) (Hue standard deviation)
The type of oral health alterations are defined by
- presence of multiple caries
- oro facial dysmorphologies
- dental abnormalities
- health oral state
Measured: every 6 months for 1year, and then each year for 4 years
Correlation between muscle activity and the type of oral health alteration
Muscle activity will be evaluated by measuring the electromyographic activity of masseter and temporal muscles during mastication of gelatines of various hardness.
The type of oral health alterations are defined by
- presence of multiple caries
- oro facial dysmorphologies
- dental abnormalities
- health oral state
Measured: every 6 months for 1year, and then each year for 4 years
Correlation between mastiaction capability and quality of life
The quality of life will be assessed using questionnaires:
- ECOHIS for children less than 6 years old
- COHIP for children above 6 years old
Mastication capability is evaluated by particle size analysis (D50).
Measured: every 6 months for 1year, and then each year for 4 years
Correlation between mastication behavior and quality of life
The quality of life will be assessed using questionnaires:
- ECOHIS for children less than 6 years old
- COHIP for children above 6 years old
Mastication behavior is measured by measuring the number of food refusals during mastication tests, measuring the kinematic parameters (number of cycle (nc), mastication time (T) to calculate the masticatory frequency (nc/T)
Measured: every 6 months for 1year, and then each year for 4 years
Correlation between mastication muscular activity and quality of life
The quality of life will be assessed using questionnaires:
- ECOHIS for children less than 6 years old
- COHIP for children above 6 years old
Muscle activity will be evaluated by measuring the electromyographic activity of masseter and temporal muscles during mastication of gelatines of various hardness.
Measured: every 6 months for 1year, and then each year for 4 years
Correlation between mastication performance and quality of life
The quality of life will be assessed using questionnaires:
- ECOHIS for children less than 6 years old
- COHIP for children above 6 years old
Mastication performance is evaluated by measuring the heterogeneity of the color of a bicolor chewing gum masticated during a given number of cycles (chewgum test) (Hue standard deviation)
Measured: every 6 months for 1year, and then each year for 4 years
Correlation between mastication capability and eating habits
Eating habits are measured by measuring the number of food refusals and texture adaptation at home according to the 7 categories of food (PNNS)
Mastication capability is evaluated by particle size analysis (D50).
Measured: every 6 months for 1year, and then each year for 4 years
Correlation between mastication behavior and eating habits
Eating habits are measured by measuring the number of food refusals and texture adaptation at home according to the 7 categories of food (PNNS)
Mastication behavior is measured by measuring the number of food refusals during mastication tests, measuring the kinematic parameters (number of cycle (nc), mastication time (T) to calculate the masticatory frequency (nc/T)
Measured: every 6 months for 1year, and then each year for 4 years
Correlation between muscular activity and eating habits
Eating habits are measured by measuring the number of food refusals and texture adaptation at home according to the 7 categories of food (PNNS)
Muscle activity will be evaluated by measuring the electromyographic activity of masseter and temporal muscles during mastication of gelatines of various hardness.
Measured: every 6 months for 1year, and then each year for 4 years
Correlation between mastication performance and eating habits
Eating habits are measured by measuring the number of food refusals and texture adaptation at home according to the 7 categories of food (PNNS)
Mastication performance is evaluated by measuring the heterogeneity of the color of a bicolor chewing gum masticated during a given number of cycles (chewgum test) (Hue standard deviation)
Measured: every 6 months for 1year, and then each year for 4 years
Correlation between mastication behavior and height and weight status
Mastication behavior is measured by measuring the number of food refusals during mastication tests, measuring the kinematic parameters (number of cycle (nc), mastication time (T) to calculate the masticatory frequency (nc/T)
Height and weight status is evaluated by calculating the BMI (body mass index) of children
Measured: every 6 months for 1year, and then each year for 4 years
Correlation between muscular activity and height and weight status
Muscle activity will be evaluated by measuring the electromyographic activity of masseter and temporal muscles during mastication of gelatines of various hardness.
Height and weight status is evaluated by calculating the BMI (body mass index) of children
Measured: every 6 months for 1year, and then each year for 4 years
Correlation between mastication performance and height and weight status
Mastication performance is evaluated by measuring the heterogeneity of the color of a bicolor chewing gum masticated during a given number of cycles (chewgum test) (Hue standard deviation)
Height and weight status is evaluated by calculating the BMI (body mass index) of children
Measured: every 6 months for 1year, and then each year for 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start5 Jul 2022
- Primary completionSep 2031 (estimated)
- Study completionFeb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MasticationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Odontologie Clinique UR4847
- Responsible party
- Sponsor
- Investigators
- Valérie Collado, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821140
- Sponsor's protocol ID
- RBHP 2021 COLLADO
- Other IDs
- 2021-A00478-33
- Acronym
- KIDYCROC
- Status last verified
- Nov 2022
- First submitted
- 9 Dec 2022
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05821140
- Acronym / sponsor ID
- KIDYCROC / RBHP 2021 COLLADO
- Conditions
- Mastication, Disability, Oral Stage, Child Development
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Centre de Recherche en Odontologie Clinique UR4847
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Feb 2032 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| children with ECC | Experimental | Procedure: dental treatment for global oral rehabilitation, Other: oral health check upChildren under 6 with early childhood caries receiving comprehensive dental treatment under general anesthesia |
| Children with orofacial dysmorphologies/malocclusion | Experimental | Procedure: dental treatment for global oral rehabilitation, Other: oral health check upChildren with orofacial dysmorphologies/malocclusion associated or not with a general condition and in need of a functional or orthodontic treatment |
| Children with dental abnormalities | Experimental | Procedure: dental treatment for global oral rehabilitation, Other: oral health check upChildren with dental abnormalities associated or not with a general condition and in need of conservative, orthodontic or prosthetic treatment |
| children with healthy oral state | Experimental | Other: oral health check upchildren with healthy oral state in the course of their annual follow-up visits. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
- children with multiple caries, requiring full rehabilitation under sedation or general anesthesia +/- prosthetic rehabilitation,
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dental treatment for global oral rehabilitationdental treatment can include conservative, orthodontic, prosthetic or surgical procedures | Procedure or surgery | Children with dental abnormalities, Children with orofacial dysmorphologies/malocclusion, children with ECC |
| oral health check upregular preventive follow-up visit (every 6 months) | Other | Children with dental abnormalities, Children with orofacial dysmorphologies/malocclusion, children with ECC, children with healthy oral state |
Primary outcome
Particle size analysis of ready to swallow natural food bolus
Time frame: at 6 months
Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
Particle size analysis of ready to swallow natural food bolus
Time frame: at 12 months
Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
Particle size analysis of ready to swallow natural food bolus
Time frame: at 18 months
Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
Particle size analysis of ready to swallow natural food bolus
Time frame: at 24 months
Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
Particle size analysis of ready to swallow natural food bolus
Time frame: at 36 months
Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
Particle size analysis of ready to swallow natural food bolus
Time frame: at 48 months
Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
Particle size analysis of ready to swallow natural food bolus
Time frame: at 60 months
Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals.
15 secondary outcomes
Correlation between mastication capability, and the type of oral health alteration
Time frame: every 6 months for 1year, and then each year for 4 years
Correlation between mastication behavior and the type of oral health alteration
Time frame: every 6 months for 1year, and then each year for 4 years
Correlation between mastication performance and the type of oral health alteration
Time frame: every 6 months for 1year, and then each year for 4 years
Correlation between muscle activity and the type of oral health alteration
Time frame: every 6 months for 1year, and then each year for 4 years
Correlation between mastiaction capability and quality of life
Time frame: every 6 months for 1year, and then each year for 4 years
Correlation between mastication behavior and quality of life
Time frame: every 6 months for 1year, and then each year for 4 years
Correlation between mastication muscular activity and quality of life
Time frame: every 6 months for 1year, and then each year for 4 years
Correlation between mastication performance and quality of life
Time frame: every 6 months for 1year, and then each year for 4 years
Correlation between mastication capability and eating habits
Time frame: every 6 months for 1year, and then each year for 4 years
Correlation between mastication behavior and eating habits
Time frame: every 6 months for 1year, and then each year for 4 years
Correlation between muscular activity and eating habits
Time frame: every 6 months for 1year, and then each year for 4 years
Correlation between mastication performance and eating habits
Time frame: every 6 months for 1year, and then each year for 4 years
Correlation between mastication behavior and height and weight status
Time frame: every 6 months for 1year, and then each year for 4 years
Correlation between muscular activity and height and weight status
Time frame: every 6 months for 1year, and then each year for 4 years
Correlation between mastication performance and height and weight status
Time frame: every 6 months for 1year, and then each year for 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valérie Collado principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental treatment for global oral rehabilitation and oral health check up in people with Mastication and Disability, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Particle size analysis of ready to swallow natural food bolus (time frame: at 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.