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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

NCT07659041 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-06-22

No results posted yet for this study

Summary

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

Conditions

  • Orthodontic Relapse
  • Retention in Orthodontic

Interventions

DEVICE

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

DEVICE

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) .

Sponsors & Collaborators

  • University of Malaya

    collaborator OTHER

  • Universiti Teknologi Mara

    collaborator OTHER

  • National University of Malaysia

    lead OTHER

Principal Investigators

  • Asma Ashari, MClinDent Lon · National University of Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07659041 on ClinicalTrials.gov