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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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

Eligibility

Primary outcome measure(s)

• Change in maxillary transverse skeletal width and intermolar width from T0 to T2 — -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
  The primary outcome is the difference in transverse skeletal maxillary width and maxillary intermolar width between baseline (T0) and the end of the 3-month retention period (T2). Skeletal measurements will be obtained from standardized posteroanterior cephalometric radiographs, and dental measurements will be obtained from digital model analysis.

Trial sites (1)

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