Maxillary ExpansionNCT07667933
Evaluation of Palatal Rugae-Based Identification After Maxillary Expansion Using Local Morphological Patch Analysis
A study testing SARME and MARPE in people with Maxillary Expansion and Forensic Dentistry, run by Semmelweis University at 1 site in Hungary.
Trial summary
This study investigates the reliability of palatal rugae-based identification following maxillary expansion procedures, including Miniscrew-Assisted Rapid Palatal Expansion (MARPE) and Surgically Assisted Rapid Maxillary Expansion (SARME). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Maxillary Expansion, Forensic Dentistry, Intraoral Scanner
- What is being tested?
- SARME and MARPE
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteHungary
- Study dates
- 1 Dec 2025to 16 May 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- transverse maxillary deficiency requiring 5-8 mm of expansion
- indication for either non-surgical miniscrew-assisted palatal expansion or surgically assisted miniscrew-assisted palatal expansion
- availability of complete pre- and post-treatment intraoral scans
- good general health
- permanent dentition
Who cannot join
- Previous maxillary expansion treatment
- Craniofacial syndromes or cleft lip/palate
- Severe periodontal disease
- Active oral infection
- Systemic conditions affecting bone metabolism
- Pregnancy or breastfeeding
- Inability to comply with study procedures or follow-up visits
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the reliability of palatal rugae-based identification following maxillary expansion procedures, including Miniscrew-Assisted Rapid Palatal Expansion (MARPE) and Surgically Assisted Rapid Maxillary Expansion (SARME). Because maxillary expansion alters the morphology of the palatal vault and the spatial relationship of the palatal rugae, conventional global alignment of the anterior palate may not provide stable post-treatment identification. The study evaluates a novel three-dimensional analysis approach based on separately segmented and independently aligned palatal ruga patches, with emphasis on preserving local morphological characteristics rather than global palatal configuration. Within-subject deviations before and after treatment will be compared with between-subject deviations to determine whether individual-specific ruga morphology remains distinguishable after expansion. Machine learning-based classification models using four independently aligned ruga patches will be developed to differentiate genuine matches from impostor comparisons. The primary analysis focuses on surgical expansion groups (MARPE and SARME) to assess whether pre-expansion scans can still be matched to post-expansion scans of the same individual. Secondary analyses will compare the performance of the ruga patch model with conventional anterior palate alignment and will simulate a mixed forensic database containing both treated and untreated individuals. The findings may provide evidence for the forensic applicability of palatal rugae identification after orthopedic and surgically assisted maxillary expansion procedures.
- Conditions
- Maxillary Expansion, Forensic Dentistry, Intraoral Scanner, Orthodontic Appliance, Orthognathic Surgical Procedures
- Being tested
- SARME, MARPE, Untreated Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARMEProcedure or surgery
Surgically assisted rapid palatal expansion (SARPE
MARPEDevice
Miniscrew-assisted rapid palatal expander (MARPE)
Untreated ControlOther
Untreated Control
| Study group | Role | What they receive |
|---|---|---|
| Surgically Assisted Rapid Maxillary Expansion | Experimental | Participants in this arm will undergo surgically assisted rapid palatal expansion (SARPE). The procedure will include surgical weakening of the maxillary sutures followed by maxillary expansion using a palatal expansion appliance. The appliance will be activated according to a standardized protocol. Clinical and radiographic assessments will be performed to evaluate treatment outcomes. Receives: Procedure: SARME |
| Non-Surgically Assisted Rapid Maxillary Expansion | Experimental | Participants in this arm will undergo non-surgical maxillary expansion using a miniscrew-assisted rapid palatal expansion (MARPE) appliance. The appliance will be anchored to the palate using temporary anchorage devices (TADs) and activated according to a standardized expansion protocol. No surgical assistance will be performed in this group. Clinical and radiographic assessments will be used to evaluate treatment outcomes. Receives: Device: MARPE |
| No Maxillary Expansion | Active comparator | Participants in this arm won't undergo any maxillary expansion, or any surgery procedure. Receives: Other: Untreated Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Absolute Deviation (MAD) in Millimeters of Four Separately Aligned Palatal Ruga Patches Measured by Three-Dimensional Surface Superimposition Using ZEISS INSPECT Software
Mean absolute deviation (MAD), measured in millimeters, for each of four separately aligned palatal ruga patches obtained by three-dimensional surface superimposition using ZEISS INSPECT software. Measurements are calculated from comparisons between pre-treatment intraoral scans and follow-up intraoral scans acquired 250 days after completion of active maxillary expansion treatment.
Measured: From pre-treatment intraoral scan acquisition (Baseline) to follow-up intraoral scan acquisition performed 250 days after completion of active maxillary expansion treatment.
Secondary outcomes (1)
Mean Absolute Deviation (MAD) in Millimeters of Anterior Palatal Surface Measured by Three-Dimensional Surface Superimposition Using ZEISS INSPECT Software
Mean absolute deviation (MAD), measured in millimeters, for the anterior palatal surface, obtained by three-dimensional surface superimposition using ZEISS INSPECT software. Measurements are calculated from comparisons between pre-treatment intraoral scans and follow-up intraoral scans acquired 250 days after completion of active maxillary expansion treatment.
Measured: From pre-treatment intraoral scan acquisition (Baseline) to follow-up intraoral scan acquisition performed 250 days after completion of active maxillary expansion treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Dec 2025
- Primary completion2 May 2026
- Study completion16 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary ExpansionStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- PICO
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667933
- Sponsor's protocol ID
- SE RKEB 163/2023
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared upon reasonable request after publication of the primary results. Requests will be reviewed by the study investigators and data will be provided in accordance with institutional and ethical regulations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Palatal Rugae-Based Identification After Maxillary Expansion Using Local Morphological Patch Analysis
- ClinicalTrials.gov ID
- NCT07667933
- Acronym / sponsor ID
- SE RKEB 163/2023
- Conditions
- Maxillary Expansion, Forensic Dentistry, Intraoral Scanner, Orthodontic Appliance, Orthognathic Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 2 May 2026 (actual)
- Study completion
- 16 May 2026 (actual)
- First posted
- 25 Jun 2026 (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.
This study investigates the reliability of palatal rugae-based identification following maxillary expansion procedures, including Miniscrew-Assisted Rapid Palatal Expansion (MARPE) and Surgically Assisted Rapid Maxillary Expansion (SARME). Because maxillary expansion alters the morphology of the palatal vault and the spatial relationship of the palatal rugae, conventional global alignment of the anterior palate may not provide stable post-treatment identification. The study evaluates a novel three-dimensional analysis approach based on separately segmented and independently aligned palatal ruga patches, with emphasis on preserving local morphological characteristics rather than global palatal configuration. Within-subject deviations before and after treatment will be compared with between-subject deviations to determine whether individual-specific ruga morphology remains distinguishable after expansion. Machine learning-based classification models using four independently aligned ruga patches will be developed to differentiate genuine matches from impostor comparisons. The primary analysis focuses on surgical expansion groups (MARPE and SARME) to assess whether pre-expansion scans can still be matched to post-expansion scans of the same individual. Secondary analyses will compare the performance of the ruga patch model with conventional anterior palate alignment and will simulate a mixed forensic database containing both treated and untreated individuals. The findings may provide evidence for the forensic applicability of palatal rugae identification after orthopedic and surgically assisted maxillary expansion procedures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- PICO
| Arm | Type | Receives |
|---|---|---|
| Surgically Assisted Rapid Maxillary Expansion | Experimental | Procedure: SARMEParticipants in this arm will undergo surgically assisted rapid palatal expansion (SARPE). The procedure will include surgical weakening of the maxillary sutures followed by maxillary expansion using a palatal expansion appliance. The appliance will be activated according to a standardized protocol. Clinical and radiographic assessments will be performed to evaluate treatment outcomes. |
| Non-Surgically Assisted Rapid Maxillary Expansion | Experimental | Device: MARPEParticipants in this arm will undergo non-surgical maxillary expansion using a miniscrew-assisted rapid palatal expansion (MARPE) appliance. The appliance will be anchored to the palate using temporary anchorage devices (TADs) and activated according to a standardized expansion protocol. No surgical assistance will be performed in this group. Clinical and radiographic assessments will be used to evaluate treatment outcomes. |
| No Maxillary Expansion | Active comparator | Other: Untreated ControlParticipants in this arm won't undergo any maxillary expansion, or any surgery procedure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- transverse maxillary deficiency requiring 5-8 mm of expansion
- indication for either non-surgical miniscrew-assisted palatal expansion or surgically assisted miniscrew-assisted palatal expansion
- availability of complete pre- and post-treatment intraoral scans
- good general health
- permanent dentition
Key exclusion criteria (7 listed)
- Previous maxillary expansion treatment
- Craniofacial syndromes or cleft lip/palate
- Severe periodontal disease
- Active oral infection
- Systemic conditions affecting bone metabolism
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 |
|---|---|---|
| SARMESurgically assisted rapid palatal expansion (SARPE | Procedure or surgery | Surgically Assisted Rapid Maxillary Expansion |
| MARPEMiniscrew-assisted rapid palatal expander (MARPE) | Device | Non-Surgically Assisted Rapid Maxillary Expansion |
| Untreated ControlUntreated Control | Other | No Maxillary Expansion |
Primary outcome
Mean Absolute Deviation (MAD) in Millimeters of Four Separately Aligned Palatal Ruga Patches Measured by Three-Dimensional Surface Superimposition Using ZEISS INSPECT Software
Time frame: From pre-treatment intraoral scan acquisition (Baseline) to follow-up intraoral scan acquisition performed 250 days after completion of active maxillary expansion treatment.
Mean absolute deviation (MAD), measured in millimeters, for each of four separately aligned palatal ruga patches obtained by three-dimensional surface superimposition using ZEISS INSPECT software. Measurements are calculated from comparisons between pre-treatment intraoral scans and follow-up intraoral scans acquired 250 days after completion of active maxillary expansion treatment.
1 secondary outcome
Mean Absolute Deviation (MAD) in Millimeters of Anterior Palatal Surface Measured by Three-Dimensional Surface Superimposition Using ZEISS INSPECT Software
Time frame: From pre-treatment intraoral scan acquisition (Baseline) to follow-up intraoral scan acquisition performed 250 days after completion of active maxillary expansion treatment.
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 13 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared upon reasonable request after publication of the primary results. Requests will be reviewed by the study investigators and data will be provided in accordance with institutional and ethical regulations.
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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 SARME and MARPE in people with Maxillary Expansion and Forensic Dentistry, 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 5 inclusion and 7 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 13 Aug 2026. 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?
Mean Absolute Deviation (MAD) in Millimeters of Four Separately Aligned Palatal Ruga Patches Measured by Three-Dimensional Surface Superimposition Using ZEISS INSPECT Software (time frame: From pre-treatment intraoral scan acquisition (Baseline) to follow-up intraoral scan acquisition performed 250 days after completion of active maxillary expansion treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.