Identity, BodyNCT05349942
A Digital Method for Measurement of Palatal Asymmetry in Twins
A study testing Intraoral scanning and data acquisition in people with Identity, Body and Palate; Deformity, run by Semmelweis University at 1 site in Hungary.
Trial summary
The aim of the study is to evaluate the digital palatal model as a possible tool of human identification. Read more about this study
- Who is it for?
- Ages 17 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Identity, Body, Palate; Deformity
- What is being tested?
- Intraoral scanning and data acquisition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteHungary
- Study dates
- 10 Jan 2019to 29 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Monozygotic twins
- Same-sex Dizygotic twins
- Opposite-sex Dizygotic twins
- Triplets
Who cannot join
- Marfan-syndrome
- Non-twins
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University, Department of Conservative Dentistry
Budapest, 1088
About this study
The aim of the study is to evaluate the digital palatal model as a possible tool of human identification.
Read the 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.
- Conditions
- Identity, Body, Palate; Deformity
- Being tested
- Intraoral scanning and data acquisition
- Keywords
- Human identification, Palate morphology, Intraoral scanner, Digital dentistry
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intraoral scanning and data acquisition | Experimental | Not described Receives: Device: Intraoral scanning and data acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 second between data acquisition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start10 Jan 2019
- Primary completion20 Feb 2019
- Study completion29 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Identity, BodyStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Vag Janos, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349942
- Sponsor's protocol ID
- MIRROR
- Status last verified
- Apr 2022
- First submitted
- 15 Feb 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39543590Simon 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.
PubMed 37202781
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Method for Measurement of Palatal Asymmetry in Twins
- ClinicalTrials.gov ID
- NCT05349942
- Acronym / sponsor ID
- MIRROR
- Conditions
- Identity, Body, Palate; Deformity
- Keywords
- Human identification, Palate morphology, Intraoral scanner, Digital dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 29 Sep 2019 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intraoral scanning and data acquisition | Experimental | Device: Intraoral scanning and data acquisition |
Who may qualify
- Ages
- 17 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Monozygotic twins
- Same-sex Dizygotic twins
- Opposite-sex Dizygotic twins
- Triplets
Key exclusion criteria (2 listed)
- Marfan-syndrome
- Non-twins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoral scanning and data acquisitionIntraoral 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. | Device | Intraoral scanning and data acquisition |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 39543590Mikolicz 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.
- Derived from this study: PubMed 37202781Simon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoral scanning and data acquisition in people with Identity, Body and Palate; Deformity, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deviation value between 3 human palatal scans (time frame: 30 second between data acquisition). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05349942, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.