NCT05349942

Brief Summary

The aim of the study is to evaluate the digital palatal model as a possible tool of human identification.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2019

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

1 month

First QC Date

February 15, 2022

Last Update Submit

April 22, 2022

Conditions

Identity, BodyPalate; Deformity

Keywords

Human identificationPalate morphologyIntraoral scannerDigital dentistry

Outcome Measures

Primary Outcomes (5)

  • Deviation value between 3 human palatal scans

    The deviation value will be measured in mm between three human palatal scans of the same individual by GOM Inspection software.

    30 second between data acquisition

  • Deviation value among scans

    The deviation value will be measured in mm between 9 comparisons of twin siblings by GOM Inspection software.

    30 second between data acquisition

  • Deviation value between 2 scans

    The deviation value will be measured in mm between 2 human palatal scans of the same individual by GOM Inspection software.

    30 second between data acquisition

  • Deviation value between original scans and mirrored scans of the individual

    The deviation value will be measured in mm between the original human palatal scans and mirrored human palatal scans of the same individual by GOM Inspection software.

    30 second between data acquisition

  • Deviation value between original human palatal scans and mirrored human palatal scans of the twins

    The deviation value will be measured in mm between the original human palatal scans and mirrored human palatal scans of twin siblings by GOM Inspection software.

    30 second between data acquisition

Study Arms (1)

Intraoral scanning and data acquisition

EXPERIMENTAL
Device: Intraoral scanning and data acquisition

Interventions

Intraoral scanning and data acquisitionDEVICE

Intraoral scanner data acquisition, 3 scans are taken for each participant. Data will be exported from dedicated software (Planmeca, Romexis) and imported into GOM surface analysis software. Sample comparisons and sample preparation are performed here. The results are collected in excel spreadsheets and analyzed in SPSS statistical software.

Intraoral scanning and data acquisition

Eligibility Criteria

Age17 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Monozygotic twins
  • Same-sex Dizygotic twins
  • Opposite-sex Dizygotic twins
  • Triplets

You may not qualify if:

  • Marfan-syndrome
  • Non-twins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University, Department of Conservative Dentistry

Budapest, 1088, Hungary

Location

Related Publications (2)

  • Mikolicz A, Simon B, Roudgari A, Shahbazi A, Vag J. Human identification via digital palatal scans: a machine learning validation pilot study. BMC Oral Health. 2024 Nov 14;24(1):1381. doi: 10.1186/s12903-024-05162-0.

    PMID: 39543590DERIVED

  • Simon B, Mangano FG, Pal A, Simon I, Pellei D, Shahbazi A, Vag J. Palatal asymmetry assessed by intraoral scans: effects of sex, orthodontic treatment, and twinning. A retrospective cohort study. BMC Oral Health. 2023 May 18;23(1):305. doi: 10.1186/s12903-023-02993-1.

    PMID: 37202781DERIVED

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Intraoral scanner (Planmeca Emerald) data acquisition, 3 scans are taken for each participant. Data will be exported from dedicated software (Planmeca, Romexis) and imported into GOM surface analysis software. Sample comparisons and sample preparation are performed here. The results are collected in excel spreadsheets and analyzed in SPSS statistical software.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 15, 2022

First Posted

April 27, 2022

Study Start

January 10, 2019

Primary Completion

February 20, 2019

Study Completion

September 29, 2019

Last Updated

April 27, 2022

Record last verified: 2022-04

Locations

HU(1)