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

NCT ID: NCT06851897

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-14

Study Completion Date

2025-06-01

Brief Summary

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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

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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.

Conditions

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Bond, Pair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional fixed retainer

multistrand or braided metal wire

Group Type ACTIVE_COMPARATOR

conventional fixed retainer

Intervention Type OTHER

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

Perforated 3D printed metal fixed retainer

3D printed wire custom made to each patient after intraoral scanning

Group Type EXPERIMENTAL

perforated 3D printed metal fixed retainer

Intervention Type OTHER

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.

Interventions

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perforated 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.

Intervention Type OTHER

conventional fixed retainer

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mariam Alaa

OTHER

Sponsor Role lead

Responsible Party

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Mariam Alaa

Assistant Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mariam MA Elsebaey, Phd

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo University

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mariam MA Elsebaey, Phd

Role: CONTACT

201006031988

Facility Contacts

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Mariam MA Elsebaey, PhD

Role: primary

2001006031988

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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Cairo University

Identifier Type: OTHER

Identifier Source: secondary_id

Orth 332

Identifier Type: -

Identifier Source: org_study_id

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