3D Evaluation of Maxillary Expansion Methods

December 2, 2025 updated by: Büşra Zeynep Yörük

Three-Dimensional Evaluation of the Effects of Different Maxillary Expansion Methods

This controlled prospective clinical trial aims to evaluate the effectiveness of different maxillary expansion methods in children with maxillary transverse deficiency. A total of 60 participants will be included: 20 patients will receive Invisalign Palatal Expander (IPE), 20 will receive acrylic cap splint Rapid Maxillary Expansion (RME), and 20 will serve as an untreated control group. Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months. Primary outcomes include maxillary arch width, first molar angulation, palatal surface area, and palatal volume. Secondary outcomes include soft tissue changes in the facial region. This study provides a direct comparison between a traditional and a modern digital expansion method, generating evidence for clinical decision-making in pediatric orthodontics.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Maxillary transverse deficiency is a common craniofacial problem that often presents with posterior crossbite and dental crowding. Rapid Maxillary Expansion (RME) achieves sutural separation and bone remodeling, typically activated at 0.5 mm per day. Invisalign® Palatal Expander (IPE) is a modern digital system using 3D printing to produce removable nylon expanders adapted to palatal curvature, with 0.25 mm activations, simplifying oral hygiene and eliminating screw activation.

This controlled prospective clinical trial will recruit 60 children with maxillary transverse deficiency. Participants will be assigned to three groups: IPE (n=20), RME (n=20), and untreated control (n=20). Intraoral scans will be obtained at the end of expansion, at 3 months, and at 6 months to create three-dimensional digital models. Maxillary dental arch widths, first molar angulations, palatal surface areas, and volumes will be measured. Extraoral 3D facial scans will evaluate soft tissue changes, including nasal tip, alar width, and interzygomatic distance.

Statistical analyses will be performed using SPSS, applying t-tests for intra- and inter-group comparisons. The study aims to provide comparative data on a traditional (RME) and a contemporary digital (IPE) maxillary expansion method. No prior studies have directly compared these two techniques in children.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34093
        • Recruiting
        • Bezmialem Vakif University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Children aged 6-12 years
  • Good oral hygiene and adequate patient cooperation
  • No previous orthodontic expansion treatment

Exclusion Criteria:

  • Systemic diseases affecting growth, bone metabolism, or craniofacial development
  • Craniofacial syndromes or congenital anomalies
  • Severe behavioral or cooperation problems
  • Previous orthodontic or orthopedic maxillary expansion
  • Patients undergoing medications that affect bone metabolism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IPE Group
Participants in this group will receive treatment with the Invisalign Palatal Expander (IPE). Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months.
Device: Invisalign Palatal Expander (IPE)
A removable, nylon palatal expander produced via digital workflow and 3D printing. Activations are planned at 0.25 mm per activation according to manufacturer protocol. Device is fitted to palatal curvature and used until desired expansion achieved, followed by retention.
Experimental: RME Group
Participants in this group will receive treatment with an acrylic cap splint Rapid Maxillary Expansion (RME) appliance. Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months.
Device: Acrylic Cap Splint Rapid Maxillary Expansion (RME) Appliance
Bonded acrylic cap splint RME with a jackscrew activated typically at 0.5 mm per day until expansion goal is reached, followed by retention period. Used in pediatric orthodontic practice.
No Intervention: Control Group
Participants in this group will not receive orthodontic expansion treatment during the study period and will serve as untreated controls. 3D intraoral and extraoral scans will be obtained at the same time points as treatment groups (end of expansion period equivalent, 3 months, 6 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Maxillary First Molar Tipping
Time Frame: Baseline (T0), 3 months after expansion (T1), and 6-month retention period (T2)
The angulation of the maxillary first molars will be measured using three-dimensional digital models obtained at T0, at 3 months after completion of expansion (T1), and at the 6-month retention follow-up (T2). Angular changes will be calculated through superimposition of maxillary 3D models and standardized angular measurements.
Baseline (T0), 3 months after expansion (T1), and 6-month retention period (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Büşra Zeynep Yörük

Collaborators

Centerdent Orthodontics & Aesthetic Dentistry Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E.181356

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) from this study, including intraoral and extraoral 3D scans, radiographs will be made available to other researchers upon reasonable request. All data will be anonymized to protect patient confidentiality. Access requests will be reviewed by the principal investigator, and researchers will be required to sign a data use agreement to ensure appropriate and secure use of the data.

IPD Sharing Time Frame

Data will be available beginning 6 months after publication of the study results, for a period of 5 years.

IPD Sharing Access Criteria

De-identified individual participant data (IPD), including intraoral and extraoral 3D scans, radiographs along with the study protocol, statistical analysis plan, and analytic code, will be available to qualified researchers. Access will be granted upon reasonable request, reviewed by the principal investigator. Researchers must submit a proposal and sign a data use agreement to ensure confidentiality and appropriate use of the data. Data will be shared through a secure repository after publication of the primary results.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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