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Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances

NCT07599202 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-05-20

No results posted yet for this study

Summary

The goal of this clinical trial is to determine whether two types of rapid maxillary expansion (RME) appliances produce different outcomes in children. RME is a treatment utilized to expand a narrow upper jaw. This study will include children aged 8 to 10 years who need upper jaw expansion during the mixed dentition period (when they have both temporary and permanent teeth).

The main questions this study aims to answer are:

* Do 3D-printed expansion appliances produce different skeletal and dental changes compared to conventionally fabricated appliances?
* Do children feel more comfortable with one type of appliance?
* Is there a difference in pain levels or oral hygiene between the two groups?

Researchers aimed to compare a conventionally fabricated expansion appliance manufactured in a dental laboratory with a 3D-printed expansion appliance produced digitally to determine whether the method of production affects treatment outcomes and patient comfort.

Participants:

* Being treated with one of the two expansion appliances (assigned randomly)
* Follow a standard activation protocol at home with parental guidance
* Attend regular clinic visits during expansion and retention phases
* Have dental photographs, X-rays, and digital scans taken before and after treatment
* Complete an oral health-related quality of life questionnaire
* Rate their pain using a pain scale
* Have their oral hygiene measured

Conditions

  • Maxillary Constriction

Interventions

DEVICE

Laboratory-fabricated rapid maxillary expansion appliance

A rapid maxillary expansion (RME) appliance fabricated on a dental cast obtained from conventional impressions. The expansion screw arms are adapted and soldered to orthodontic molar bands on the cast.

DEVICE

3D-printed rapid maxillary expansion appliance

A rapid maxillary expansion (RME) appliance fabricated using digital intraoral scan data. Dental models are generated from intraoral scans, and the appliance framework is manufactured as a single-piece structure using three-dimensional (3D) metal printing with sintered cobalt-chromium alloy.

Sponsors & Collaborators

  • Baskent University

    lead OTHER

Principal Investigators

  • Habibe Sinem Ince Bingol, DDS, Orthodontist · Hacettepe Unversity, Faculty of Dentistry, Department of Orthodontics

  • Sinem Tekdemir, DDS · Baskent University, Faculty of Dentistry, Department of Orthodontics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-07
Primary Completion
2026-07-31
Completion
2026-09-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07599202 on ClinicalTrials.gov