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

14. Mai 2026 aktualisiert von: Baskent University

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

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

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

48

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Türkei (türkiye)
      • Ankara, Türkei (türkiye), 06490
        • Baskent University Faculty of Dentistry, Department of Orthodontics

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Laboratory-fabricated rapid maxillary expansion appliance
Participants are treated with a laboratory-fabricated rapid maxillary expansion (RME) appliance produced on a dental cast obtained from conventional impressions. The arms of the palatal expansion screw are adapted and soldered to orthodontic molar bands on the cast model. Following adaptation, acrylic resin is added in the palatal region to increase the force distribution area. The appliance is cemented to the teeth using glass ionomer cement. Activation and retention protocols are standardized across both groups.
Gerät: 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.
Andere Namen:
  • Conventional rapid maxillary expansion appliance
  • Modified haas-type RME appliance used in mixed dentition
Experimental: 3D-printed rapid maxillary expansion appliance
Participants are treated with a rapid maxillary expansion (RME) appliance fabricated using digital intraoral scans. Dental models are generated from intraoral scan data, and the appliance framework, including the arms and tooth-supporting components, is manufactured as a single-piece structure using three-dimensional (3D) metal printing technology with sintered cobalt-chromium alloy. After fabrication, acrylic resin is added to the palatal region to increase the force distribution area. The appliance is cemented to the teeth using glass ionomer cement. Activation and retention protocols are standardized across both groups.
Gerät: 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.
Andere Namen:
  • Digitally fabricated modified haas-type RME appliance used in mixed dentition

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in maxillary transverse skeletal width and intermolar width from T0 to T2
Zeitfenster: -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.
-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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Wong-Baker FACES Pain Rating Scale score
Zeitfenster: -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.
-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)
Child Perceptions Questionnaire (CPQ 8-10)
Zeitfenster: -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.
-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)
Modified Silness-Löe Plaque Index score
Zeitfenster: -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.
-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)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
3D digital model superimposition-based surface deviation
Zeitfenster: -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.
-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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Baskent University

Ermittler

  • Studienstuhl: Habibe Sinem Ince Bingol, DDS, Orthodontist, Hacettepe Unversity, Faculty of Dentistry, Department of Orthodontics
  • Hauptermittler: Sinem Tekdemir, DDS, Baskent University, Faculty of Dentistry, Department of Orthodontics

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

7. August 2025

Primärer Abschluss (Geschätzt)

1. Juli 2026

Studienabschluss (Geschätzt)

1. September 2026

Studienanmeldedaten

Zuerst eingereicht

23. Februar 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Mai 2026

Zuerst gepostet (Tatsächlich)

20. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • D-KA24/41
  • 2025-066 (Andere Kennung: Turkish Medicines and Medical Devices Agency Clinical Trial Authorization Number)
  • 25/31 (Andere Kennung: Baskent University Institutional Ethics Committee Approval Number)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data (IPD) will not be shared due to institutional policies, ethical committee regulations, and patient confidentiality considerations.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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