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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bond, Pair
• Intervention / Treatment: Other: conventional fixed retainer; Other: perforated 3D printed metal fixed retainer

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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional fixed retainer; multistrand or braided metal wire	Other: conventional fixed retainer; Conventional fixed metal retainer will be used. Multi strand wire will be used
Experimental: Perforated 3D printed metal fixed retainer; 3D printed wire custom made to each patient after intraoral scanning	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bond Failure	Counting number of teeth debonded immediately after placement of wire up to 12 months	immediate up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chairside Time		Baseline
Plaque accumulation	By using Loe & Silness plaque index to go give score for each tooth.	every 3 months up to 6 months
Wire breakage	Through detecting (by naked eye) any breakage in fixed retainer wire intrarally.	every 3 months for 12 months
Post treatment relapse	By using Little irregularity index to detect any teeth irregularity that may occur starting from placement of wire till 12 months.	after 12 months

Collaborators and Investigators

• Sponsor: Mariam Alaa
• Investigators: Principal Investigator: Mariam MA Elsebaey, Phd, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2025
• Primary Completion (Actual): March 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): February 28, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Behavior, Animal; Consummatory Behavior; Sexual Behavior, Animal; Pair Bond
• Other Study ID Numbers: Orth 332; Cairo University (Other Identifier: Cairo University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No