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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05573295
Other study ID # 2021/68
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date August 15, 2024

Study information

Verified date March 2024
Source Istanbul University
Contact Yelda Kasimoglu Eldem, Assoc. Prof.
Phone 00905336233978
Email yelda.kasimoglu@istanbul.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. It is aimed to create a new formula if there is a significant difference in dental age between children with CLP and healthy controls.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date August 15, 2024
Est. primary completion date July 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 14 Years
Eligibility Inclusion Criteria: - 5-14 years old - Healthy children - Children with CLP - Patients without missing left mandibular permanent teeth on panoramic radiography 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Diagnostic 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.
Diagnostic 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.
Diagnostic 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.

Locations

Country Name City State
Turkey Istanbul University, Faculty of Dentistry Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation coefficient of Willems method Dental age of children with Cleft Lip and Palate and healthy controls assessed by the correlation coefficient day 1
Primary Correlation coefficient of London Atlas method. Dental age of children with Cleft Lip and Palate and healthy controls assessed by the correlation coefficient. day 1
Primary Correlation coefficient of Cameriere European formula. Dental age of children with Cleft Lip and Palate and healthy controls assessed by the correlation coefficient. day 1
Secondary Dental age estimation in children with Cleft Lip and Palate Dental age estimation in Turkish children day 1
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