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

NCT07667933 | Completed

• 1 other identifier: SE RKEB 163/2023
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

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

  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 Outcomes (1)

• Mean Absolute Deviation (MAD) in Millimeters of Anterior Palatal Surface Measured by Three-Dimensional Surface Superimposition Using ZEISS INSPECT Software

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

Study Arms (3)

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.

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.

Device: MARPE

No Maxillary Expansion

ACTIVE COMPARATOR

Participants in this arm won't undergo any maxillary expansion, or any surgery procedure.

Other: Untreated Control

Interventions

SARME PROCEDURE

Surgically assisted rapid palatal expansion (SARPE

Surgically Assisted Rapid Maxillary Expansion

MARPE DEVICE

Miniscrew-assisted rapid palatal expander (MARPE)

Non-Surgically Assisted Rapid Maxillary Expansion

Untreated Control OTHER

Untreated Control

No Maxillary Expansion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University

Budapest, Pest County, 1088, Hungary

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PICO

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 25, 2026
• Study Start: December 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: May 16, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

HU (1)