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RecruitingNCT05573295Updated Aug 27, 2024

Dental Age Estimation by Different Methods in Patients With Cleft Lip and Palate

An observational study in Dental Age Estimation and Cleft Lip and Palate, sponsored by Istanbul University. Recruiting at 1 site in Turkey. Open to participants aged 5 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by Istanbul University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Mar 2022; still recruiting 4 years 8 months later.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
240
Ages
5 Years to 14 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Dental Age Estimation
  • Cleft Lip and Palate

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Keywords

  • children
  • dental age estimation
  • Cleft Lip and Palate
  • chronological age
  • London Atlas
  • Cameriere European Formula
  • Willems method
03

In context

Cleft Lip

168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.

This study's planned enrollment of 240 is above the median of 100 across 49 observational studies indexed under Cleft Lip.

Browse Cleft Lip studies →

Lead sponsor

Istanbul University is the lead sponsor of 511 studies on the registry; 78 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 5-14 years old
  • Healthy children
  • Children with CLP
  • Patients without missing left mandibular permanent teeth on panoramic radiography

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
240 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherDiagnostic Test: Willems method

    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.

  • OtherDiagnostic Test: Cameriere method

    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.

  • OtherDiagnostic Test: London Atlas method

    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.

06

What researchers measure

Primary outcomes

  1. Correlation coefficient of Willems method

    Dental age of children with Cleft Lip and Palate and healthy controls assessed by the correlation coefficient

    Time frame: day 1

  2. Correlation coefficient of London Atlas method.

    Dental age of children with Cleft Lip and Palate and healthy controls assessed by the correlation coefficient.

    Time frame: day 1

  3. Correlation coefficient of Cameriere European formula.

    Dental age of children with Cleft Lip and Palate and healthy controls assessed by the correlation coefficient.

    Time frame: day 1

Secondary outcomes

  1. Dental age estimation in children with Cleft Lip and Palate

    Dental age estimation in Turkish children

    Time frame: day 1

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2022 (actual). Primary completion is estimated for Nov 2024, 32 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2022
First posted
Oct 10, 2022
StartActual
Mar 1, 2022
Primary completionEst.
Nov 15, 2024
CompletionEst.
Dec 15, 2024
Last update
Aug 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05573295
Responsible party
Yelda Kasımoğlu (Principal investigator, Istanbul University) — Principal investigator
First posted
Oct 10, 2022
Start date
Mar 1, 2022
Primary completion
Nov 15, 2024 (estimated)
Completion
Dec 15, 2024 (estimated)
Last update
Aug 27, 2024

Study contacts

Yelda Kasimoglu Eldem, Assoc. Prof.
Contact
yelda.kasimoglu@istanbul.edu.tr
00905336233978

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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