A Digital Method for Measurement of Palatal Asymmetry in Twins

• Sponsor: Semmelweis University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05349942
• Collaborator: (none)
• Enrollment: 201
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.6
• Patients Per Site Per Month: 23.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Identity, Body; Palate; Deformity	Device: Intraoral scanning and data acquisition	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 201 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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.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)
• Primary Purpose: Screening
• Official Title: A Digital Method for Measurement of Palatal Asymmetry in Twins
• Actual Study Start Date: Jan 10, 2019
• Actual Primary Completion Date: Feb 20, 2019
• Actual Study Completion Date: Sep 29, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Deviation value between 3 human palatal scans [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.

2. Deviation value among scans [30 second between data acquisition]

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

3. Deviation value between 2 scans [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.

4. Deviation value between original scans and mirrored scans of the individual [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.

5. Deviation value between original human palatal scans and mirrored human palatal scans of the twins [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Monozygotic twins

• Same-sex Dizygotic twins

• Opposite-sex Dizygotic twins

• Triplets

Exclusion Criteria:

• Marfan-syndrome

• Non-twins

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Semmelweis University, Department of Conservative Dentistry	Budapest		Hungary	1088

Sponsors and Collaborators

• Semmelweis University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Vag Janos, Professor, Semmelweis University
• ClinicalTrials.gov Identifier: NCT05349942
• Other Study ID Numbers: MIRROR
• First Posted: Apr 27, 2022
• Last Update Posted: Apr 27, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Vag Janos, Professor, Semmelweis University: Human identification; Palate morphology; Intraoral scanner; Digital dentistry
• Additional relevant MeSH terms: Congenital Abnormalities

Study Results

No Results Posted as of Apr 27, 2022