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NCT Number: NCT07262892

3D Evaluation of 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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location status: Recruiting

Location contact

Banu Kılıç, Associate Professor

CONTACT

[email protected]

+90 532 243 2756

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Invisalign Palatal Expander (IPE)

Device

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.

Acrylic Cap Splint Rapid Maxillary Expansion (RME) Appliance

Device

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Banu Kılıç, Associate Professor

CONTACT

[email protected]

+90 532 243 2756

Büşra Zeynep Yörük, Phd Student

CONTACT

[email protected]

+90 531 287 8055

Sponsors and collaborators

Lead sponsor

Büşra Zeynep Yörük

Other

Collaborators

  • Centerdent Orthodontics & Aesthetic Dentistry Clinic

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

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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