OdontologyPhyDentchildNCT03620214
Physiological and Oral Dental Parameters of Young Child
An observational study of Odontology, run by CHU de Reims at 1 site in France.
Trial summary
The aim of this study is to measure some oral and maxillofacial physiological parameters, with a view to creating a modular prototype articulator from young children to adolescents by 3D printing. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Odontology
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2018to 23 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Healthy children consulting at the odontology department of Reims CHU for carious screening or orthodontic diagnosis; excluding research
Who may be able to join
- First 30 children in each age group ([3; 6 [; [6; 9 [; [9; 12]) presenting to the Odontology Division as part of a first dental care or orthodontic consultation.
Who cannot join
- Any child consulting to the Odontology Department in emergencies.
- Any child coming out of the weight-of- height growth curve. For example, a child below is considered to have hypo-development. Conversely, a child located above the growth curve is considered to be hyper-developed.
- Any child with absence of at least 2 teeth per quadrant whether it is a genetic etiology (agenesis), infectious (avulsion) or traumatic (expulsion).
- Any child with a maxillofacial malformation generating disorders of the face development (ex: child with a cleft palate ...)
- Any child presenting a Class III of Angle. Indeed the intermaxillary ratios being reversed, a hypo-development of the maxillary is often observed.
- Any child with a cognitive impairment that limits the understanding of the examination undertaken.
- Any non-cooperating child
Trial locations and contacts
1 site in 1 country.
Véronique VALLOT contact
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Marie-Paule GELLE, 0326913455 ext. 0033, marie-paule.gelle@univ-reims.fr
About this study
Official title: Descriptive Study of the Physiological and Oral Parameters of the Young Child to the Adolescent
The aim of this study is to measure some oral and maxillofacial physiological parameters, with a view to creating a modular prototype articulator from young children to adolescents by 3D printing.
Read the detailed description
In the dental field, the articulators present different interests during the diagnostic and treatments of the dental diseases. Thus they are used to perform dental prostheses, pre-orthodontic analysis or in the context of dysfunction of the manducatory apparatus.
Many children affecting with genetic disease need prosthetic rehabilitation. However, none commercial articulators are adaptable to children. Consequently little dental prosthetic are taken before adolescence, or even adulthood.
The aim of this study is to measure some oral and maxillofacial physiological parameters, with a view to creating a modular prototype articulator from young children to adolescents by 3D printing.
On average, 30 children per week visit the dental department of Reims CHU for dental screening or orthodontic diagnosis. From this cohort, an epidemiological study will be carried out. It will concern different physiological parameters of the face and the oral cavity necessary to make a prototype articulator.
Ideally, the creation of a modular articulator to monitor the growth of a child would remove a number of diagnostic locks, therapeutic and technical.
- Conditions
- Odontology
- Keywords
- CHILD, GROWTH, PHYSIOLOGICAL PARAMETERS, FACE, MAXILLARY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy children | Healthy children consulting at the odontology department of Reims CHU for carious screening or orthodontic diagnosis; excluding research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-ear distance
distance between ears
Measured: Day 0
Measurements of the upper floor of the face
distance between the hair line and the glabella (in cm) measured using a calliper
Measured: Day 0
Inter-commissural distance when closed and opened mouth
Distance between commissures of the lips, mouth opened and closed
Measured: Day 0
Tempo-mandibular joint
The calculation of the condylar track inclination (in degrees) will be done using an axiographe or the displacement of the mandible in propulsion
Measured: Day 0
Frontal plane
distance between the two pterygoid-maxillary ligaments
Measured: Day 0
Inter canine distance
distance between canines
Measured: Day 0
Measurements of the middle floor of the face
distance between the glabella and the sub nasal point (in cm) measured using a calliper
Measured: Day 0
Measurements of the lower floor of the face
distance between the sub nasal point ans the chin (in cm) measured using a calliper
Measured: Day 0
Secondary outcomes (2)
age
age in years
Measured: Day 0
sex
male or female
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start23 May 2018
- Primary completion23 Sep 2018 (estimated)
- Study completion23 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OdontologyStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620214
- Sponsor's protocol ID
- PO18043
- Acronym
- PhyDentchild
- Status last verified
- Jul 2018
- First submitted
- 28 Mar 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of the Physiological and Oral Parameters of the Young Child to the Adolescent
- ClinicalTrials.gov ID
- NCT03620214
- Acronym / sponsor ID
- PhyDentchild / PO18043
- Conditions
- Odontology
- Keywords
- CHILD, GROWTH, PHYSIOLOGICAL PARAMETERS, FACE, MAXILLARY
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 23 May 2018 (actual)
- Primary completion
- 23 Sep 2018 (estimated)
- Study completion
- 23 Sep 2018 (estimated)
- First posted
- 8 Aug 2018 (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.
The aim of this study is to measure some oral and maxillofacial physiological parameters, with a view to creating a modular prototype articulator from young children to adolescents by 3D printing.
Detailed description
In the dental field, the articulators present different interests during the diagnostic and treatments of the dental diseases. Thus they are used to perform dental prostheses, pre-orthodontic analysis or in the context of dysfunction of the manducatory apparatus.
Many children affecting with genetic disease need prosthetic rehabilitation. However, none commercial articulators are adaptable to children. Consequently little dental prosthetic are taken before adolescence, or even adulthood.
The aim of this study is to measure some oral and maxillofacial physiological parameters, with a view to creating a modular prototype articulator from young children to adolescents by 3D printing.
On average, 30 children per week visit the dental department of Reims CHU for dental screening or orthodontic diagnosis. From this cohort, an epidemiological study will be carried out. It will concern different physiological parameters of the face and the oral cavity necessary to make a prototype articulator.
Ideally, the creation of a modular articulator to monitor the growth of a child would remove a number of diagnostic locks, therapeutic and technical.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy children | – | –Healthy children consulting at the odontology department of Reims CHU for carious screening or orthodontic diagnosis; excluding research |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Healthy children consulting at the odontology department of Reims CHU for carious screening or orthodontic diagnosis; excluding research
Key inclusion criteria (1 listed)
- First 30 children in each age group ([3; 6 [; [6; 9 [; [9; 12]) presenting to the Odontology Division as part of a first dental care or orthodontic consultation.
Key exclusion criteria (7 listed)
- Any child consulting to the Odontology Department in emergencies.
- Any child coming out of the weight-of- height growth curve. For example, a child below is considered to have hypo-development. Conversely, a child located above the growth curve is considered to be hyper-developed.
- Any child with absence of at least 2 teeth per quadrant whether it is a genetic etiology (agenesis), infectious (avulsion) or traumatic (expulsion).
- Any child with a maxillofacial malformation generating disorders of the face development (ex: child with a cleft palate ...)
- Any child presenting a Class III of Angle. Indeed the intermaxillary ratios being reversed, a hypo-development of the maxillary is often observed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inter-ear distance
Time frame: Day 0
distance between ears
Measurements of the upper floor of the face
Time frame: Day 0
distance between the hair line and the glabella (in cm) measured using a calliper
Inter-commissural distance when closed and opened mouth
Time frame: Day 0
Distance between commissures of the lips, mouth opened and closed
Tempo-mandibular joint
Time frame: Day 0
The calculation of the condylar track inclination (in degrees) will be done using an axiographe or the displacement of the mandible in propulsion
Frontal plane
Time frame: Day 0
distance between the two pterygoid-maxillary ligaments
Inter canine distance
Time frame: Day 0
distance between canines
Measurements of the middle floor of the face
Time frame: Day 0
distance between the glabella and the sub nasal point (in cm) measured using a calliper
Measurements of the lower floor of the face
Time frame: Day 0
distance between the sub nasal point ans the chin (in cm) measured using a calliper
2 secondary outcomes
age
Time frame: Day 0
sex
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
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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. This study is not recruiting at the moment.
Véronique VALLOT contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Odontology, run by CHU de Reims 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Paule GELLE (0326913455 ext. 0033, marie-paule.gelle@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-ear distance (time frame: Day 0). The study lists 8 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 8 Aug 2018.