Dental Age EstimationNCT05573295
Dental Age Estimation by Different Methods in Patients With Cleft Lip and Palate
An observational study of Dental Age Estimation and Cleft Lip and Palate, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate whether there is a significant difference in dental age between children with CLP and healthy controls using the Willems method, Cameriere European formula and London Atlas. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Age Estimation, Cleft Lip and Palate
- What is being tested?
- Diagnostic Test: Willems method, Diagnostic Test: Cameriere method and Diagnostic Test: London Atlas method
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 15 Dec 2024
- 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 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study was conducted on gender-age matched healthy control group of children aged 5-14 years, who applied to Istanbul University Faculty of Dentistry, Department of Pedodontics, had an AI record in their anamnesis, had panoramic radiographs in the archive of the Department of Oral and Maxillofacial Radiology, Istanbul University Faculty of Dentistry.
Who may be able to join
- 5-14 years old
- Healthy children
- Children with CLP
- Patients without missing left mandibular permanent teeth on panoramic radiography
Who cannot join
- Children younger than 5 years old and older than 14 years (children that cannot be assessed by the Willems and Cameriere method)
- Poor quality panoramic radiography
- Patients who have received orthodontic treatment
- Patients who received restorative or endodontic treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University, Faculty of Dentistry
Istanbul
Yelda Kasimoglu Eldem, Assoc. Prof.
About this study
Official title: Evaluation of Dental Age of Children With Cleft Lip and Palate Using Willems Method, Cameriere European Formula, and London Atlas
The aim of this study is to investigate whether there is a significant difference in dental age between children with CLP and healthy controls using the Willems method, Cameriere European formula and London Atlas. It is aimed to create a new formula if there is a significant difference in dental age between children with CLP and healthy controls.
Read the detailed description
Dental age is widely evaluated by pedodontists, forensic dentists and orthodontists. While a delay in tooth development may be associated with growth retardation and learning difficulties, dental age determination can also be used for forensic age determination for children whose birth information is uncertain. A clear assessment of maturation in children with continued growth is important in establishing a dental treatment plan.
There are two basic approaches to dental age determination in children:
evaluation of eruption of teeth in the oral cavity, evaluation of the development and mineralization of crowns and roots on dental radiographs.
In many methods, the developmental stages of different numbers of permanent teeth are used.
The most commonly used method for determining dental age in children; is the Demirjian method that evaluates the development of seven left permanent mandibular teeth in eight stages (from A to H). Willems et al. In 2001, they modified the Demirjian method by conducting a study on the fact that it showed higher age determination in the Belgian Caucasian population. The adapted method was named the Willems method. It is stated that one of the advantages of this method is that it is a relatively simple system for determining tooth age.
One of the most widely used methods of dental age determination recently is the European formula of Cameriere et al., which is calculated based on open apex. It has been reported that this method has been tested on different population groups, and the results are accurate and reliable.
An atlas method was proposed by a group of London researchers in 2010. The Atlas shows all the teeth array images of certain age groups as a schematic series. Age determination is made by deciding which reference image matches the individual's panoramic radiography image more.
- Conditions
- Dental Age Estimation, Cleft Lip and Palate
- Being tested
- Diagnostic Test: Willems method, Diagnostic Test: Cameriere method, Diagnostic Test: London Atlas method
- Keywords
- children, dental age estimation, Cleft Lip and Palate, chronological age, London Atlas, Cameriere European Formula, Willems method
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: Willems methodOther
Willems method measures the developmental stages of the seven left permanent mandibular teeth and is frequently used for dental age estimation. The score of each stage is allocated, and the sum of the scores provides an evaluation of the subject's dental maturity.
Diagnostic Test: Cameriere methodOther
Cameriere et al. designed a quantitative approach through a formula based on sex and the ratio between length and apex opening measurements of each lower left tooth.
Diagnostic Test: London Atlas methodOther
The London Atlas requires the user to assess the tooth development and eruption and then match it to one of the 31 pictures of age categories.
| Study group | Role | What they receive |
|---|---|---|
| Children with CLP | Not described Receives: Other: Diagnostic Test: Willems method; Other: Diagnostic Test: Cameriere method; Other: Diagnostic Test: London Atlas method | |
| Healthy controls with gender-age match | Not described Receives: Other: Diagnostic Test: Willems method; Other: Diagnostic Test: Cameriere method; Other: Diagnostic Test: London Atlas method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient of Willems method
Dental age of children with Cleft Lip and Palate and healthy controls assessed by the correlation coefficient
Measured: day 1
Correlation coefficient of London Atlas method.
Dental age of children with Cleft Lip and Palate and healthy controls assessed by the correlation coefficient.
Measured: day 1
Correlation coefficient of Cameriere European formula.
Dental age of children with Cleft Lip and Palate and healthy controls assessed by the correlation coefficient.
Measured: day 1
Secondary outcomes (1)
Dental age estimation in children with Cleft Lip and Palate
Dental age estimation in Turkish children
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Mar 2022
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Age EstimationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yelda Kasımoğlu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573295
- Sponsor's protocol ID
- 2021/68
- Status last verified
- Mar 2024
- First submitted
- 7 Oct 2022
- Last updated
- 27 Aug 2024
- 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dental Age of Children With Cleft Lip and Palate Using Willems Method, Cameriere European Formula, and London Atlas
- ClinicalTrials.gov ID
- NCT05573295
- Acronym / sponsor ID
- 2021/68
- Conditions
- Dental Age Estimation, Cleft Lip and Palate
- Keywords
- children, dental age estimation, Cleft Lip and Palate, chronological age, London Atlas, Cameriere European Formula, Willems method
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 10 Oct 2022 (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 investigate whether there is a significant difference in dental age between children with CLP and healthy controls using the Willems method, Cameriere European formula and London Atlas. It is aimed to create a new formula if there is a significant difference in dental age between children with CLP and healthy controls.
Detailed description
Dental age is widely evaluated by pedodontists, forensic dentists and orthodontists. While a delay in tooth development may be associated with growth retardation and learning difficulties, dental age determination can also be used for forensic age determination for children whose birth information is uncertain. A clear assessment of maturation in children with continued growth is important in establishing a dental treatment plan.
There are two basic approaches to dental age determination in children:
evaluation of eruption of teeth in the oral cavity, evaluation of the development and mineralization of crowns and roots on dental radiographs.
In many methods, the developmental stages of different numbers of permanent teeth are used.
The most commonly used method for determining dental age in children; is the Demirjian method that evaluates the development of seven left permanent mandibular teeth in eight stages (from A to H). Willems et al. In 2001, they modified the Demirjian method by conducting a study on the fact that it showed higher age determination in the Belgian Caucasian population. The adapted method was named the Willems method. It is stated that one of the advantages of this method is that it is a relatively simple system for determining tooth age.
One of the most widely used methods of dental age determination recently is the European formula of Cameriere et al., which is calculated based on open apex. It has been reported that this method has been tested on different population groups, and the results are accurate and reliable.
An atlas method was proposed by a group of London researchers in 2010. The Atlas shows all the teeth array images of certain age groups as a schematic series. Age determination is made by deciding which reference image matches the individual's panoramic radiography image more.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with CLP | – | Other: Diagnostic Test: Willems method, Other: Diagnostic Test: Cameriere method, Other: Diagnostic Test: London Atlas method |
| Healthy controls with gender-age match | – | Other: Diagnostic Test: Willems method, Other: Diagnostic Test: Cameriere method, Other: Diagnostic Test: London Atlas method |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study was conducted on gender-age matched healthy control group of children aged 5-14 years, who applied to Istanbul University Faculty of Dentistry, Department of Pedodontics, had an AI record in their anamnesis, had panoramic radiographs in the archive of the Department of Oral and Maxillofacial Radiology, Istanbul University Faculty of Dentistry.
Key inclusion criteria (4 listed)
- 5-14 years old
- Healthy children
- Children with CLP
- Patients without missing left mandibular permanent teeth on panoramic radiography
Key exclusion criteria (4 listed)
- Children younger than 5 years old and older than 14 years (children that cannot be assessed by the Willems and Cameriere method)
- Poor quality panoramic radiography
- Patients who have received orthodontic treatment
- Patients who received restorative or endodontic treatment
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 |
|---|---|---|
| Diagnostic Test: Willems methodWillems method measures the developmental stages of the seven left permanent mandibular teeth and is frequently used for dental age estimation. The score of each stage is allocated, and the sum of the scores provides an evaluation of the subject's dental maturity. | Other | Children with CLP, Healthy controls with gender-age match |
| Diagnostic Test: Cameriere methodCameriere et al. designed a quantitative approach through a formula based on sex and the ratio between length and apex opening measurements of each lower left tooth. | Other | Children with CLP, Healthy controls with gender-age match |
| Diagnostic Test: London Atlas methodThe London Atlas requires the user to assess the tooth development and eruption and then match it to one of the 31 pictures of age categories. | Other | Children with CLP, Healthy controls with gender-age match |
Primary outcome
Correlation coefficient of Willems method
Time frame: day 1
Dental age of children with Cleft Lip and Palate and healthy controls assessed by the correlation coefficient
Correlation coefficient of London Atlas method.
Time frame: day 1
Dental age of children with Cleft Lip and Palate and healthy controls assessed by the correlation coefficient.
Correlation coefficient of Cameriere European formula.
Time frame: day 1
Dental age of children with Cleft Lip and Palate and healthy controls assessed by the correlation coefficient.
1 secondary outcome
Dental age estimation in children with Cleft Lip and Palate
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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.
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 Dental Age Estimation and Cleft Lip and Palate, run by Istanbul University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 27 Aug 2024. 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 Turkey (Türkiye). 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 Yelda Kasimoglu Eldem, Assoc. Prof. (00905336233978, yelda.kasimoglu@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient of Willems method (time frame: day 1). The study lists 3 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 27 Aug 2024.