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

14. maj 2026 opdateret af: 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

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
      • Ankara, Tyrkiet (Türkiye), 06490
        • Baskent University Faculty of Dentistry, Department of Orthodontics

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Andre navne:
  • Conventional rapid maxillary expansion appliance
  • Modified haas-type RME appliance used in mixed dentition
Eksperimentel: 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.
Enhed: 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.
Andre navne:
  • Digitally fabricated modified haas-type RME appliance used in mixed dentition

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in maxillary transverse skeletal width and intermolar width from T0 to T2
Tidsramme: -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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Wong-Baker FACES Pain Rating Scale score
Tidsramme: -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)
Tidsramme: -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
Tidsramme: -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)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
3D digital model superimposition-based surface deviation
Tidsramme: -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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Baskent University

Efterforskere

  • Studiestol: Habibe Sinem Ince Bingol, DDS, Orthodontist, Hacettepe Unversity, Faculty of Dentistry, Department of Orthodontics
  • Ledende efterforsker: Sinem Tekdemir, DDS, Baskent University, Faculty of Dentistry, Department of Orthodontics

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. august 2025

Primær færdiggørelse (Anslået)

1. juli 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

23. februar 2026

Først indsendt, der opfyldte QC-kriterier

14. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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