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ACTIVE NOT RECRUITING
NCT07599202
NA

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

Sponsor: Baskent University

View on ClinicalTrials.gov

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

Official title: Comparison of the Skeletal and Dentoalveolar Effects and Patient Comfort of Conventional and 3D-Printed Maxillary Expansion Appliances in Mixed Dentition Patients

Key Details

Gender

All

Age Range

7 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2025-08-07

Completion Date

2026-12

Last Updated

2026-09-04

Healthy Volunteers

No

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.

Locations (1)

Baskent University Faculty of Dentistry, Department of Orthodontics

Ankara, Turkey (Türkiye)