3D Evaluation of Maxillary Expansion Methods

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Maxillary Transverse Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Acrylic Cap Splint Rapid Maxillary Expansion (RME) Appliance

Intervention Type 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.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Invisalign Palatal Expander (IPE)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes