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NCT Number: NCT07599202

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Maxillary Constriction

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baskent University Faculty of Dentistry, Department of Orthodontics

Ankara, 06490, Turkey (Türkiye)

About this study

Treatment effectiveness, amount of expansion, and patient comfort will be evaluated between the two groups. Additionally, the impact of digital appliance production on treatment outcomes and patient satisfaction will be investigated.

This prospective, parallel-group, randomized clinical trial aims to compare the skeletal, dentoalveolar, and patient-reported effects of conventionally fabricated and three-dimensional (3D) printed rapid maxillary expansion (RME) appliances in children with transverse maxillary deficiency during the mixed dentition period.

Participants aged 8-10 years who meet the predefined inclusion criteria and require rapid maxillary expansion as part of their orthodontic treatment will be enrolled.

The results are expected to contribute evidence-based guidance for orthodontists when selecting appliance fabrication methods, balancing biological effectiveness with patient comfort and quality-of-life considerations.

Findings from this study may also support future digital workflow integration strategies in pediatric orthodontic treatment planning.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged between 7 and 11 years
  • In the mixed dentition period
  • Fully erupted permanent first molars
  • Presence of primary canines and primary second molars suitable for use as anchorage units for at least 6 months
  • Angle Class I or Class II molar relationship
  • Presence of posterior crossbite and/or moderate maxillary transverse deficiency or moderate crowding
  • Prepubertal growth stage corresponding to Cervical Vertebral Maturation Stage 1 (CVM1) or Stage 2 (CVM2)
  • Receiving orthodontic treatment at the Başkent University Department of Orthodontics
  • Parents or legal guardians willing to provide written informed consent

Exclusion criteria

  • Previous orthodontic treatment
  • Periodontal disease
  • Enamel hypocalcification or significant calcium deficiency
  • Root resorption
  • Signs or symptoms of temporomandibular joint dysfunction
  • Angle Class III molar relationship
  • Craniofacial syndromes
  • Cleft lip and/or palate
  • Known allergy to acrylic materials or metal alloys
  • Inability to maintain adequate oral hygiene during treatment
  • Lack of cooperation during treatment
  • Repeated appliance breakage or dislodgement (three or more times)

Treatment and study plan

Laboratory-fabricated rapid maxillary expansion appliance

Device

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.

Other names: Conventional rapid maxillary expansion appliance, Modified haas-type RME appliance used in mixed dentition

3D-printed rapid maxillary expansion appliance

Device

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.

Other names: Digitally fabricated modified haas-type RME appliance used in mixed dentition

Primary outcomes

  1. Change in maxillary transverse skeletal width and intermolar width from T0 to T2

    Time frame: -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.

Secondary outcomes

  1. Wong-Baker FACES Pain Rating Scale score

    Time frame: -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)

    Pain perception will be assessed using the Wong-Baker FACES Pain Rating Scale at predefined time points during treatment. Scores will be recorded and compared between groups.

  2. Child Perceptions Questionnaire (CPQ 8-10)

    Time frame: -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)

    Oral health-related quality of life will be assessed using the validated Child Perceptions Questionnaire (CPQ 8-10). Total and domain scores (oral symptoms, functional limitations, emotional well-being, social well-being) will be recorded and compared between groups.

  3. Modified Silness-Löe Plaque Index score

    Time frame: -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)

    Oral hygiene status will be evaluated using the Modified Silness-Löe Plaque Index at predefined time points during treatment to monitor plaque accumulation and compare oral hygiene changes between groups.

Other outcomes

  1. 3D digital model superimposition-based surface deviation

    Time frame: -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)

    Digital models obtained at T0 and T2 will be superimposed using the medial two-thirds of the third palatal rugae and the posterior palatal vault as stable reference areas.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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