3D Evaluation of Maxillary Expansion Methods

ConditionMaxillary Transverse Deficiency

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-12

SponsorBüşra Zeynep Yörük

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged 6-12 years

Good oral hygiene and adequate patient cooperation

No previous orthodontic expansion treatment

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 3 treatment groups

Group A: IPE GroupExperimental treatment 1 intervention

Group B: RME GroupExperimental treatment 1 intervention

Group C: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

Change in Maxillary First Molar Tipping

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.

Time frame

Baseline (T0), 3 months after expansion (T1), and 6-month retention period (T2)

Sponsors and contacts

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Büşra Zeynep Yörük

Lead sponsor

Bezmialem Vakif University

Sponsor institution

Centerdent Orthodontics & Aesthetic Dentistry Clinic

Collaborator

Source ClinicalTrials.gov

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