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Effectiveness, Patient Acceptance, and Cost Estimation of 3D-printed Retainer Compared to Hawley Retainer in Expansion Case: a Randomized Controlled Trial

15. juni 2026 oppdatert av: ASMA ASHARI, National University of Malaysia
Expansion of the arches is generally considered highly unstable and prone to relapse regardless of the type of expansion. Retention appliances play a vital role in preserving these changes. Hawley retainer users often avoid wearing them due to speech difficulties and less aesthetic appeal. They are also more prone to breakage, costlier, and require more labour. Despite the relatively recent introduction of 3D-printed retainers, they offer potential advantages in orthodontics, including the accuracy of digitally scanned images, reduced labour and material costs, and improved patient comfort. While 3D-printed retainers are quite new, most studies focus on laboratory testing of their mechanical properties, there is limited evidence directly comparing their effectiveness in retaining arch width increases, patient acceptance, and cost estimation. This knowledge gap creates uncertainty about the optimal choice of retainer for long-term stability, necessitating a comparative assessment of their performance. This study addresses this knowledge gap by evaluating the retention of arch width increases achieved using Hawley retainers versus 3D-printed retainers

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Maxillary dentoalveolar expansion is a procedure to correct transverse discrepancies between the maxillary and mandibular arches by applying forces to widen the maxillary arch. This procedure is inherently unstable and is susceptible to relapse. While Hawley retainers (HR) have served as the established standard for retention after maxillary expansion, recent studies have shown that modified thermoforming retainers can be as effective as HR. The emergence of computer-aided design and computer-aided manufacturing (CAD-CAM) and three-dimensional (3D) printing technology has significantly streamlined fabricating appliances and prostheses. 3D printing material is more rigid, with superior compression and tensile strength. Thus, a normal shape 3D-printed retainer may be a viable choice for the retention of maxillary expansion. A recent systematic review highlighted a critical gap in knowledge regarding the long-term clinical efficacy and durability of 3D-printed retainers. Thus, the present study aimed to address this research gap by investigating the long-term clinical effectiveness, patient acceptance, and cost estimation of 3D-printed retainers in expansion cases. This study will be carried out as a multicentre prospective randomized controlled clinical trial (RCT) conducted at Universiti Kebangsaan Malaysia (UKM), Universiti Malaya (UM), and Universiti Teknologi MARA (UiTM). Orthodontic patients who fulfil the inclusion criteria will be randomly allocated into the HR or 3D-printed retainer groups. Dental casts of patients will be measured at intercanine width (ICW), inter-premolar width (IPMW), inter-first molar mesiobuccal cusp width 1 (IFMW1), and inter-first molar distobuccal cusp width 2 (IFMW2) for both groups at debond(T0), 3(T1), 6(T2), and 12(T3). The outcome assessor and data analyst will be blinded to the retention method. The researcher will evaluate the patient's acceptance at T2 & T3 and conduct a cost analysis at T1 post-debond. The findings of this study will contribute valuable data to the field of orthodontics, aiding clinicians in determining the most effective long-term retention strategy for patients who have undergone maxillary dentoalveolar expansion.

Studietype

Intervensjonell

Registrering (Antatt)

28

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Asma Ashari, BDS Adel, MClinDent Lon, MOrth
  • Telefonnummer: +603 8921 5555
  • E-post: asmaashari@ukm.edu.my

Studer Kontakt Backup

Studiesteder

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50300
        • National University of Malaysia
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mei Ling Cheng
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
        • University Malaya
        • Ta kontakt med:
        • Underetterforsker:
          • Zhang Yi Tan
    • Selangor
      • Sungai Buloh, Selangor, Malaysia, 47000
        • University Teknologi Mara Selangor branch
        • Ta kontakt med:
        • Underetterforsker:
          • Siti Nor Hafizah Salehun

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Patients aged 16 years or older at the time of debonding
  • Treatment plan of extraction or non-extraction followed by straight wire appliances in the upper arch only or both arches
  • Undergone expansion treatment in the upper arch causing an arch width increase of 3-10mm, either using a Quadhelix, expansion with archwires, or URA with midline screw
  • Had pretreatment dental cast
  • Had no chronic medical condition.

Exclusion Criteria:

  • Cleft lip and palate
  • Chronic medical conditions
  • Broken teeth or bubbles on study model at site of measurement.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Hawley retainer
A screening will be done to select suitable patients for the study. Only patients who fulfil the criteria will be invited to participate in this study. Following informed consent, eligible subjects will be randomly allocated into one of two groups wither hawley retainer or 3D printed retainer. Fabrication of Hawley retainers will be done using a standardized design across all centres.
Enhet: Hawley retainer
Hawley retainers have served as the established standard for retention after maxillary expansion. Standard design of Hawley Retainer: - Labial bow (0.8mm hard stainless steel) from canine to canine - Adam clasp on the molar (0.7mm hard stainless steel) - acrylic baseplate (2-3mm thickness) .
Eksperimentell: 3D printed retainer
A screening will be done to select suitable patients for the study. Only patients who fulfil the criteria will be invited to participate in this study. Following informed consent, eligible subjects will be randomly allocated into one of two groups wither hawley retainer or 3D printed retainer. Fabrication of 3d printed retainers will be done using a standardized design at one main centres by one technician using Nextdent Orhtoflex Resin.
Enhet: 3D printed retainer

3D-printed retainer Using Nextdent Orthoflex resin

Standard design of 3D printed retainer:

  • Monolithic design (no wires)
  • Thickness 0.8mm-1.0 mm
  • Fully cover the teeth and part of the gingiva (1-2mm)
  • Undercut block - 0.25-0.5mm

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Retention of the maxillary expansion
Tidsramme: 12 months
  1. Subjects will be scheduled for follow-up at T1-T3 after the initiation of retention wear. During these visits, impressions will be acquired with alginate impression material, and ICW, IPMW, IFMW1, and IFMW2 will be measured intraorally and on dental casts.
  2. Calibrated researchers will collect the study models, and the ID and intervention will be covered by opaque tape once they are ready for measurement. Only one dental cast at a time will be picked out of its box without showing any previous measurements. Two dental casts from the same patient will not be measured in connection. Due to the prospective nature of the study, it was inconvenient to anonymize dental casts from the start of the study.
  3. Intraclass correlation coefficient (ICC) will be done within and between researchers one week after the T0.
12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient acceptance
Tidsramme: 12 months

Subjects will be given and asked to complete a questionnaire on patient acceptance (see attachment) at 6 and 12 months post-debond. The Questionnaire has been validated and published by (Saw et al. 2025). It uses a Visual Analogue Scale (VAS) to ask six questions related to subject acceptance of orthodontic retainers in fitting, speech, appearance, oral hygiene, durability, and comfort.

Refer to Attachment 1 (Malay version) and Attachment 2 (English Version) for the questionnaires.
12 months
cost estimation
Tidsramme: 6 months
To estimate and compare the costs associated with the implementation and provision of 3D-printed retainers between clinics with existing in-house 3D-printing facilities and clinics planning to acquire 3D-printing services. The analysis will include direct costs such as equipment acquisition, materials, software, maintenance, laboratory procedures, and staff chairside time.
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National University of Malaysia

Samarbeidspartnere

University of Malaya
Universiti Teknologi Mara

Etterforskere

  • Studieleder: Asma Ashari, MClinDent Lon, National University of Malaysia

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

8. juni 2026

Først innsendt som oppfylte QC-kriteriene

15. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • JEP 2025-630 (Annen identifikator: National university of Malaysia)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

Only data relevant to the study analyses will be provided. All personal identifiers and information that could reveal participant identity will be removed to protect confidentiality and comply with ethical requirements.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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