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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 giugno 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

28

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Asma Ashari, BDS Adel, MClinDent Lon, MOrth
  • Numero di telefono: +603 8921 5555
  • Email: asmaashari@ukm.edu.my

Backup dei contatti dello studio

Luoghi di studio

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50300
        • National University of Malaysia
        • Contatto:
        • Investigatore principale:
          • Mei Ling Cheng
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
        • University Malaya
        • Contatto:
        • Sub-investigatore:
          • Zhang Yi Tan
    • Selangor
      • Sungai Buloh, Selangor, Malaysia, 47000
        • University Teknologi Mara Selangor branch
        • Contatto:
        • Sub-investigatore:
          • Siti Nor Hafizah Salehun

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Dispositivo: 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) .
Sperimentale: 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.
Dispositivo: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Retention of the maxillary expansion
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient acceptance
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National University of Malaysia

Collaboratori

University of Malaya
Universiti Teknologi Mara

Investigatori

  • Direttore dello studio: Asma Ashari, MClinDent Lon, National University of Malaysia

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

8 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 giugno 2026

Primo Inserito (Effettivo)

22 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • JEP 2025-630 (Altro identificatore: National university of Malaysia)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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