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.

Study Overview

• Status: Completed
• Conditions: Maxillary Expansion; Orthodontic Appliance; Orthognathic Surgical Procedures; Intraoral Scanner; Forensic Dentistry
• Intervention / Treatment: Device: MARPE; Procedure: SARME; Other: Untreated Control

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-Surgically Assisted Rapid Maxillary Expansion; 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.	Device: MARPE; Miniscrew-assisted rapid palatal expander (MARPE)
Experimental: 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
Active Comparator: No Maxillary Expansion; Participants in this arm won't undergo any maxillary expansion, or any surgery procedure.	Other: Untreated Control; Untreated Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From pre-treatment intraoral scan acquisition (Baseline) to follow-up intraoral scan acquisition performed 250 days after completion of active maxillary expansion treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From pre-treatment intraoral scan acquisition (Baseline) to follow-up intraoral scan acquisition performed 250 days after completion of active maxillary expansion treatment.

Collaborators and Investigators

• Sponsor: Semmelweis University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Actual): March 30, 2026
• Study Completion (Actual): May 16, 2026

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 19, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 19, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SE RKEB 163/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: 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 Sharing Access Criteria: 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 Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No