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Evaluation of Palatal Rugae-Based Identification After Maxillary Expansion Using Local Morphological Patch Analysis

19. juni 2026 opdateret af: Semmelweis University
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

45

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Ungarn
    • Pest County
      • Budapest, Pest County, Ungarn, 1088
        • Semmelweis University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ikke-kirurgisk assisteret hurtig overkæbeudvidelse
Deltagerne i denne arm vil gennemgå ikke-kirurgisk maxillær ekspansion ved hjælp af et miniskrue-assisteret hurtig ganeudvidelsesapparat (MARPE). Apparatet vil blive forankret til ganen ved hjælp af midlertidige forankringsanordninger (TAD'er) og aktiveret i henhold til en standardiseret udvidelsesprotokol. Der vil ikke blive udført kirurgisk assistance i denne gruppe. Kliniske og radiografiske vurderinger vil blive brugt til at evaluere behandlingsresultaterne.
Enhed: MARPE
Miniskrueassisteret hurtig ganeudvider (MARPE)
Eksperimentel: Surgically Assisted Rapid Maxillary Expansion
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.
Procedure: SARME
Surgically assisted rapid palatal expansion (SARPE
Aktiv komparator: No Maxillary Expansion
Participants in this arm won't undergo any maxillary expansion, or any surgery procedure.
Andet: Untreated Control
Untreated Control

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Absolute Deviation (MAD) in Millimeters of Four Separately Aligned Palatal Ruga Patches Measured by Three-Dimensional Surface Superimposition Using ZEISS INSPECT Software
Tidsramme: 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.
From pre-treatment intraoral scan acquisition (Baseline) to follow-up intraoral scan acquisition performed 250 days after completion of active maxillary expansion treatment.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Absolute Deviation (MAD) in Millimeters of Anterior Palatal Surface Measured by Three-Dimensional Surface Superimposition Using ZEISS INSPECT Software
Tidsramme: 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 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.
From pre-treatment intraoral scan acquisition (Baseline) to follow-up intraoral scan acquisition performed 250 days after completion of active maxillary expansion treatment.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Semmelweis University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2025

Primær færdiggørelse (Faktiske)

30. marts 2026

Studieafslutning (Faktiske)

16. maj 2026

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

19. juni 2026

Først opslået (Faktiske)

25. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • SE RKEB 163/2023

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

De-identified individual participant data and the study protocol will be available after publication of the primary results and will remain available for 5 years.

IPD-delingsadgangskriterier

Access to de-identified individual participant data and supporting documents will be provided to qualified researchers upon reasonable request. Requests will be reviewed by the study investigators and data will be shared in accordance with institutional policies and ethical approvals.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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