NCT04907552

Brief Summary

Age can be estimated in different ways by using skeletal age and dental age. Currently, bone age is determine thanks to the wrist x-rayed, and the dental age using variation in mineralization (Demirjian's score) on the dental panoramic (Mincer 1993). More recently, reviews indicate the Computed tomography (CT) scan of the medial clavicular epiphysics can contribute to improve the accuracy of individual's age estimation (Houpert, 2016). Furthermore, with the recent advances, the very low dose CT scan acquisitions can be perform with sufficient quality for the teeth analysis. The goal of this study is to validate the use of dental CT for Demirjdian's staging method.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
557

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

May 25, 2021

Last Update Submit

May 25, 2021

Conditions

Mandible Fracture

Keywords

Dental age estimationCT scandental panoramicValidation CT scanRadiography

Outcome Measures

Primary Outcomes (1)

  • weighted Kappa test between CT scan

    weighted Kappa test between CT scan and dental panoramic assessment of Demirjian's staging of third mandibular molar

    day 1

Secondary Outcomes (2)

  • Mineralization difference

    day 1

  • Dental age estimation in a south french population

    day 1

Eligibility Criteria

Age0 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patient aged between 0 and 25 years old

You may qualify if:

  • Patient aged between 0 and 25 years old
  • Complete dental panoramic
  • CT scan including mandible and maxilla
  • Maximum of 2 months between CT scan and dental panoramic
  • Medical imaging available on the PACS

You may not qualify if:

  • Medical imaging missing on the PACS
  • Patient refuses to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw FracturesMaxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and Injuries

Study Officials

  • Catherine CYTEVAL, MD.PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Central Study Contacts

Catherine CYTEVAL, MD.PhD

CONTACT

04 67 33 81 78c-cyteval@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2021

First Posted

May 28, 2021

Study Start

November 1, 2020

Primary Completion

November 1, 2021

Study Completion

November 30, 2022

Last Updated

May 28, 2021

Record last verified: 2021-05

Locations

FR(1)