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

NCT05573295 | Recruiting

• 1 other identifier: 2021/68
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• Correlation coefficient of Willems method

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

  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.

  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.

  day 1

Secondary Outcomes (1)

• Dental age estimation in children with Cleft Lip and Palate

  day 1

Study Arms (2)

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

Diagnostic Test: Willems method OTHER

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.

Children with CLP; Healthy controls with gender-age match

Diagnostic Test: Cameriere method OTHER

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.

Children with CLP; Healthy controls with gender-age match

Diagnostic Test: London Atlas method OTHER

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.

Children with CLP; Healthy controls with gender-age match

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Faculty of Dentistry

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Yelda Kasimoglu Eldem, Assoc. Prof.

CONTACT

00905336233978; yelda.kasimoglu@istanbul.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 10, 2022
• Study Start: March 1, 2022
• Primary Completion: November 15, 2024
• Study Completion: December 15, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)