A Digital Method for Measurement of Palatal Asymmetry in Twins

April 22, 2022 updated by: Dr. Vag Janos, Semmelweis University
The aim of the study is to evaluate the digital palatal model as a possible tool of human identification.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis University, Department of Conservative Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Marfan-syndrome
  • Non-twins

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraoral scanning and data acquisition
Device: Intraoral scanning and data acquisition
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deviation value between 3 human palatal scans
Time Frame: 30 second between data acquisition
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
Time Frame: 30 second between data acquisition
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
Time Frame: 30 second between data acquisition
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
Time Frame: 30 second between data acquisition
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
Time Frame: 30 second between data acquisition
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2019

Primary Completion (Actual)

February 20, 2019

Study Completion (Actual)

September 29, 2019

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

April 22, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 22, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIRROR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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