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Completed

NCT Number: NCT07667933

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University

Budapest, Pest County, 1088, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SARME

Procedure

Surgically assisted rapid palatal expansion (SARPE

MARPE

Device

Miniscrew-assisted rapid palatal expander (MARPE)

Untreated Control

Other

Untreated Control

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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