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3D Evaluation of Maxillary Expansion Methods

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07262892
Enrollment
60
Registered
2025-12-04
Start date
2025-11-20
Completion date
2026-06-30
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Transverse Deficiency

Keywords

Maxillary Expansion, Rapid Maxillary Expansion (RME), Invisalign Palatal Expander (IPE), Transverse Maxillary Deficiency, Three-Dimensional Evaluation, Orthodontics, Pediatric Dentistry

Brief summary

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.

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.

Interventions

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.

DEVICEAcrylic 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.

Sponsors

Centerdent Orthodontics & Aesthetic Dentistry Clinic
CollaboratorUNKNOWN
Büşra Zeynep Yörük
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Maxillary First Molar TippingBaseline (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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactBanu Kılıç, Associate Professor
bkilic@bezmialem.edu.tr+90 532 243 2756
Backup ContactBüşra Zeynep Yörük, Phd Student
dr.zeynepyoruk@gmail.com+90 531 287 8055

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026