3D-Printed vs Conventional Fixed Retainers After Orthodontic Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional Multistranded Stainless Steel Fixed Retainer, 3D-Printed Cobalt-Chromium Fixed Retainer, 3D-Printed Titanium Fixed Retainer.
- Who it may be relevant to
- Registry conditions: Orthodontic Relapse, Malocclusion. Basic parameters: 21 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison Between Three-Dimensionally Printed Fixed Retainers Versus Conventional Multistranded Stainless Steel Fixed Retainers: Randomized Clinical Trial
Overview
This randomized clinical trial aims to compare the clinical performance of two types of three-dimensionally printed fixed retainers (Cobalt-Chromium and Titanium Grade 5) with the conventional multistranded stainless steel fixed retainer following orthodontic treatment. Thirty-six participants will be randomly allocated into three parallel groups with a 1:1:1 allocation ratio. The primary outcome is post-treatment stability assessed by Little's Irregularity Index and lower arch dimensions. Secondary outcomes include bond failure rate and periodontal parameters over a 12-month follow-up period.
Detailed description
Orthodontic relapse remains one of the greatest challenges following the completion of orthodontic treatment. Conventional multistranded stainless steel fixed retainers are considered the gold standard for long-term retention; however, they have several limitations, including operator-dependent adaptation, prolonged chairside time, structural instability, and possible unwanted tooth movement.
Advances in digital dentistry have introduced CAD/CAM technology and additive manufacturing (3D printing), enabling the fabrication of customized fixed retainers with improved adaptation and manufacturing accuracy. Three-dimensional printed retainers fabricated from Cobalt-Chromium (Co-Cr) and Titanium Grade 5 (Ti-6Al-4V) alloys may provide superior mechanical properties, greater manufacturing precision, and potentially improved clinical performance compared with conventional retainers.
Interventions
- Device Conventional Multistranded Stainless Steel Fixed Retainer
Conventional 0.0215-inch six-stranded stainless steel bonded fixed retainer. - Device 3D-Printed Cobalt-Chromium Fixed Retainer
Customized 3D-printed cobalt-chromium bonded fixed retainer fabricated from intraoral scans. - Device 3D-Printed Titanium Fixed Retainer
Customized 3D-printed titanium (Ti-6Al-4V) bonded fixed retainer fabricated from intraoral scans.
Primary outcome measures
- Orthodontic stability assessed using Little's Irregularity Index [Time frame: 12 months]
Secondary outcome measures (5)
- Retainer failure rate [Time frame: 12 months]
- Plaque Index (Silness and Löe Plaque Index) [Time frame: 12 months]
- Gingival Index (Löe and Silness Gingival Index) [Time frame: 12 months]
- Bleeding on Probing (BOP) [Time frame: 12 months]
- Probing Pocket Depth (PPD) [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Age range 21-35 years old after finishing orthodontic treatment.
- Presence of all maxillary and mandibular anterior teeth with normal shape and size.
- Completion of orthodontic treatment with full fixed appliances.
Exclusion criteria
- Patients with cleft lip and/or palate or any other craniofacial syndrome
- Patients with compromised oral hygiene or periodontal disease
- Patients who had orthognathic surgery
- Lingual appliance treatments
- Enamel hypoplasia, fluorosis, active caries, restorations, or fractures in the anterior teeth
- Patients who had separate arch debondings with a difference of more than 2 months in-between jaws
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07730476 · SDD-RCT-2026-01