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OpenTrials
Active, Not Recruiting

NCT Number: NCT06851897

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bond, Pair Behavior Behavior, Animal Consummatory Behavior Pair Bond Sexual Behavior, Animal

Age range

15 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

perforated 3D printed metal fixed retainer

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.

conventional fixed retainer

Other

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

Primary outcomes

  1. Bond Failure

    Time frame: immediate up to 12 months

    Counting number of teeth debonded immediately after placement of wire up to 12 months

Secondary outcomes

  1. Chairside Time

    Time frame: Baseline

  2. Plaque accumulation

    Time frame: every 3 months up to 6 months

    By using Loe & Silness plaque index to go give score for each tooth.

  3. Wire breakage

    Time frame: every 3 months for 12 months

    Through detecting (by naked eye) any breakage in fixed retainer wire intrarally.

  4. Post treatment relapse

    Time frame: after 12 months

    By using Little irregularity index to detect any teeth irregularity that may occur starting from placement of wire till 12 months.

Sponsors and collaborators

Lead sponsor

Mariam Alaa

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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