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CompletedNCT05343247Updated Aug 22, 2024

Dental Age Estimation by Different Methods in Patients With Amelogenesis Imperfecta

An observational study in Amelogenesis Imperfecta and Dental Age Estimation, sponsored by Istanbul University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 5 Years to 13 Years. Per ClinicalTrials.gov, last updated 2024-08-22.

Sponsored by Istanbul University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
416
Ages
5 Years to 13 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 amelogenesis imperfecta (AI) and healthy controls using Cameriere European formula and London Atlas. If there is a significant difference in dental age between children with AI and healthy controls, it is aimed to create a new formula.

Read the detailed description

One of the developmental enamel defects, amelogenesis imperfecta (AI), is also known as enamel hypoplasia/hypomineralization. It is a rare inherited disease that affects the enamel structure, amount and component in primary and permanent teeth, and it has been reported to be accompanied by some dental anomalies and nephrocalcinosis. Dental anomalies and nephrocalcinosis can affect tooth development, and there are limited studies examining tooth development in these individuals.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.

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:

  1. evaluation of eruption of teeth in the oral cavity,
  2. 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.

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

  • Amelogenesis Imperfecta
  • Dental Age Estimation

Keywords

  • children
  • dental age estimation
  • amelogenesis imperfecta
  • chronological age
  • London Atlas
  • Cameriere European Formula
03

In context

Lead sponsor

Istanbul University is the lead sponsor of 507 studies on the registry; 80 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 13 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

This study was conducted on gender-age matched healthy control group of children aged 5-13 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

  • 5-13 years old
  • Healthy children
  • Children with AI
  • Patients without missing left mandibular permanent teeth on panoramic radiography

Exclusion criteria

Exclusion Criteria:

  • Children older than 5 years old and younger 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
416 participants (actual)
Patient registry
No

Groups and cohorts

  • Children with AI

    Diagnostic Test: Cameriere method · Diagnostic Test: London Atlas method

  • Healthy controls with gender-age match

    Diagnostic Test: Cameriere method · Diagnostic Test: London Atlas method

Interventions

  • Diagnostic testCameriere 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.

  • Diagnostic testLondon 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 London Atlas method.

    Dental age of children with AI and healthy controls assessed by the correlation coefficient.

    Time frame: day 1

  2. Correlation coefficient of Cameriere European formula.

    Dental age of children with AI and healthy controls assessed by the correlation coefficient.

    Time frame: day 1

Secondary outcomes

  1. Dental age estimation in children with AI

    Dental age estimation in Turkish children

    Time frame: day 1

07

Study locations

1 site
  • Istanbul University, Faculty of Dentistry
    Istanbul, Turkey (Türkiye)
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

Ran from Mar 2022 to primary completion in Apr 2024, 25 months.

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

Registered
Apr 18, 2022
First posted
Apr 25, 2022
StartActual
Mar 1, 2022
Primary completionActual
Apr 15, 2024
CompletionActual
Apr 23, 2024
Last update
Aug 22, 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 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05343247
Responsible party
Yelda Kasımoğlu (Principal investigator, Istanbul University) — Principal investigator
First posted
Apr 25, 2022
Start date
Mar 1, 2022
Primary completion
Apr 15, 2024
Completion
Apr 23, 2024
Last update
Aug 22, 2024

Oversight

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

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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