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A Digital Method for Measurement of Palatal Asymmetry in Twins

Primary Purpose

Identity, Body, Palate; Deformity

Status

Completed

Phase

Not Applicable

Locations

Hungary

Study Type

Interventional

Intervention

Intraoral scanning and data acquisition

About this trial

This is an interventional screening trial for Identity, Body focused on measuring Human identification, Palate morphology, Intraoral scanner, Digital dentistry

Eligibility Criteria

17 Years - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Marfan-syndrome
Non-twins

Sites / Locations

Semmelweis University, Department of Conservative Dentistry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraoral scanning and data acquisition

Arm Description

Outcomes

Primary Outcome Measures

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.

Deviation value among scans

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

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05349942

First Posted

February 15, 2022

Last Updated

April 22, 2022

Sponsor

Semmelweis University

1. Study Identification

Unique Protocol Identification Number

NCT05349942

Brief Title

A Digital Method for Measurement of Palatal Asymmetry in Twins

Official Title

A Digital Method for Measurement of Palatal Asymmetry in Twins

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

January 10, 2019 (Actual)

Primary Completion Date

February 20, 2019 (Actual)

Study Completion Date

September 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Semmelweis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

In this research, the investigators investigate the individual characteristics of the human upper and lower dentition and palate. The investigators use digital dentistry, record the data using an intraoral scanner, and store the extracted open source file format on a secure cloud-based server. Data validation is repeated annually. By comparing the initial and control digital samples, the investigators draw conclusions about the usability of the extracted information. The aim of the study is to develop a method and data storage protocol that will allow the patient data to be used years or decades later to replace or restore lost information.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Identity, Body, Palate; Deformity

Keywords

Human identification, Palate morphology, Intraoral scanner, Digital dentistry

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

201 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intraoral scanning and data acquisition

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Intraoral scanning and data acquisition

Intervention Description

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.

Primary Outcome Measure Information:

Title

Deviation value between 3 human palatal scans

Description

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

Time Frame