NCT05343247

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2024

Completed
Last Updated

August 22, 2024

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

April 18, 2022

Last Update Submit

August 20, 2024

Conditions

Keywords

childrendental age estimationamelogenesis imperfectachronological ageLondon AtlasCameriere European Formula

Outcome Measures

Primary Outcomes (2)

  • Correlation coefficient of London Atlas method.

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

    day 1

  • Correlation coefficient of Cameriere European formula.

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

    day 1

Secondary Outcomes (1)

  • Dental age estimation in children with AI

    day 1

Study Arms (2)

Children with AI

Diagnostic Test: Cameriere methodDiagnostic Test: London Atlas method

Healthy controls with gender-age match

Diagnostic Test: Cameriere methodDiagnostic Test: London Atlas method

Interventions

Cameriere methodDIAGNOSTIC_TEST

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 AIHealthy controls with gender-age match
London Atlas methodDIAGNOSTIC_TEST

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 AIHealthy controls with gender-age match

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Amelogenesis Imperfecta

Condition Hierarchy (Ancestors)

Developmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

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

April 18, 2022

First Posted

April 25, 2022

Study Start

March 1, 2022

Primary Completion

April 15, 2024

Study Completion

April 23, 2024

Last Updated

August 22, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations