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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorNational University of Malaysia

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Cleft lip and palate

Chronic medical conditions

Broken teeth or bubbles on study model at site of measurement.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3D printed retainer

    Device

    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

  • Hawley retainer

    Device

    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) .

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Hawley retainerActive comparator 1 intervention
Group B: 3D printed retainerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Retention of the maxillary expansion

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.

Time frame
12 months

Secondary outcomes

1

Patient acceptance

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.

Time frame
12 months
2

cost estimation

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

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National University of Malaysia

Lead sponsor

University of Malaya

Collaborator

Universiti Teknologi Mara

Collaborator

This trial is not recruiting at the moment. You can still explore other options: