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Comparison of Perforated 3D Printed Versus Conventional Metal Fixed Bonded Retainer

Comparison of Perforated 3D Printed Metal Fixed Mandibular Retainer Versus Conventional Fixed Bonded Retainer A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06851897
Enrollment
64
Registered
2025-02-28
Start date
2025-02-14
Completion date
2026-06-01
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bond, Pair

Brief summary

Although different materials of mandibular fixed retainer were discussed in the literature, there is contradicting evidence regarding the bond failure of Titanium fixed metal retainer, whether immediate or after 12 months. Moreover, insufficient evidence is present regarding 3D metal printed fixed mandibular retainers.

Detailed description

In recent years a new possibility is available for dental practitioners: CAD-CAM technology and 3D printing, which find their application in all aspects of orthodontics. Orthodontists are already familiar with several products that use 3D printers (i.e. invisible aligners), also known as additive manufacturing, 3D printing is a technology whereby sequential layers of material are layered on top of one another to form an object23. Two recent articles reported the fabrication of a custom lingual retainer cut from a nickel-titanium block with CAD/CAM technology and a CAD/CAM Zirconium bar as a bonded mandibular fixed retainer.

Interventions

OTHERperforated 3D printed metal fixed retainer

The key of modification is digitally designing fixed metal retainer which will be custom made for each patient, and 3D metal printing of the fixed retention wire using Metal printer instead of using generic metal wire for all patients.

Conventional fixed metal retainer will be used. Multi strand wire will be used

Sponsors

Mariam Alaa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with properly finished orthodontic treatment. * No sex predilection. * The presence of 4 permanent mandibular incisors and 2 permanent mandibular canines. * No active caries, restorations, fractures, or periodontal disease of previously mentioned teeth * Patients with good oral hygiene.

Exclusion criteria

* Patients with no need of fixed mandibular retention. * Enamel hypoplasia or hypocalcification of mandibular anterior teeth. * Abnormal morphology of mandibular anterior teeth * Periodontal disease that contraindicates fixed orthodontic retention. * No or poor patient's compliance \& bad oral hygiene. * Psychological problems.

Design outcomes

Primary

MeasureTime frameDescription
Bond Failureimmediate up to 12 monthsCounting number of teeth debonded immediately after placement of wire up to 12 months

Secondary

MeasureTime frameDescription
Chairside TimeBaseline
Plaque accumulationevery 3 months up to 6 monthsBy using Loe \& Silness plaque index to go give score for each tooth.
Wire breakageevery 3 months for 12 monthsThrough detecting (by naked eye) any breakage in fixed retainer wire intrarally.
Post treatment relapseafter 12 monthsBy using Little irregularity index to detect any teeth irregularity that may occur starting from placement of wire till 12 months.

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORMariam MA Elsebaey, Phd

Cairo University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026