Forensic Dental Age Estimation : Validation of Computed T... | NCT04907552

Studies
Forensic Dental Age Estimation : Validation of Computed Tomography for Third Molar Demirjian's Staging

NCT04907552

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

May 28, 2021Actual

Enrollment

557Estimated

Phase

Not provided

Conditions

Mandible Fracture

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Actual

Primary Completion Date

Nov 1, 2021Estimated

Completion Date

Nov 30, 2022Estimated

First Submitted Date

May 25, 2021

First Submission Date that Met QC Criteria

May 25, 2021

First Posted Date

May 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2021

Last Update Posted Date

May 28, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

557Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Mineralization difference	Mineralization difference between mandibular and maxillar third molar	day 1
Dental age estimation in a south french population	Dental age estimation in a south french population

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

Medical imaging missing on the PACS
Patient refuses to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Patient aged between 0 and 25 years old

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Catherine CYTEVAL, MD.PhD	Contact	04 67 33 81 78	33	c-cyteval@chu-montpellier.fr

Overall Officials

Name	Affiliation	Role
Catherine CYTEVAL, MD.PhD	University Hospital, Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier	Recruiting	Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008337	Mandibular Fractures

Ancestor Terms

ID	Term
D007572	Jaw Fractures
D008446	Maxillofacial Injuries
D005151	Facial Injuries
D006259	Craniocerebral Trauma

Browse Leaves

Not provided

Browse Branches

Not provided