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

April 13, 2026 updated by: Amany Ibrahim
Despite the growing diversity of materials used for mandibular fixed retainers, the evidence base remains inconclusive. In particular, conflicting findings have been reported regarding the bond failure of titanium retainers across different evaluation periods, including immediate and 12-month outcomes. Additionally, the emergence of 3D metal-printed retainers has not yet been matched by sufficient clinical evidence, with current data being limited and lacking long-term validation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In recent years, CAD/CAM technology and 3D printing have introduced new possibilities in orthodontic practice, with expanding applications across various treatment modalities. Additive manufacturing, commonly known as 3D printing, enables the fabrication of objects through the sequential layering of material to produce precise three-dimensional structures. While orthodontists are already familiar with 3D-printed appliances such as clear aligners, the application of these technologies in fixed retention is still evolving. Recent studies have reported the fabrication of customized lingual retainers using CAD/CAM techniques, including nickel-titanium-milled retainers and zirconia bars designed for use as bonded mandibular fixed retainers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo University
      • Giza, Cairo University, Egypt
        • Amany Eltantawy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ≥ 13 years
  • Complete permanent dentition up to second molars
  • Completed Class I orthodontic treatment and requiring a mandibular fixed -bonded retainer
  • No sex predilection.

Exclusion Criteria:

  • Enamel defects that may compromise bonding (e.g., hypoplasia, fluorosis)
  • Poor oral hygiene
  • Active dental or periodontal pathology at the site of intervention
  • Lingual restorations on mandibular anterior teeth
  • Poor compliance or inability to attend follow-up visits
  • Psychological or medical conditions that may interfere with study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conventional fixed bonded retainer
Device: conventional fixed retainer
Participants will receive a conventional fixed bonded lingual retainer (canine-to-canine) fabricated using multistranded stainless steel wire and bonded using standard clinical procedures.
Experimental: Bar 3d printed metal fixed retainer
Device: bar 3d printed metal fixed retainer
Participants will receive a custom-designed 3D-printed metal fixed retainer. The retainer is digitally designed using intraoral scans and fabricated using metal 3D printing technology to achieve a precise fit tailored to each patient.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
bond failure
Time Frame: immediate (within 24 hours after bonding) and at 3, 6, 9, and 12 months
Bond failure will be assessed clinically by detecting any detachment of the retainer from the tooth surface (number of debonded teeth).
immediate (within 24 hours after bonding) and at 3, 6, 9, and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
chairside time
Time Frame: Periprocedural (during retainer bonding procedure on Day 1)

Time measurement will start from the beginning of acid etching of the teeth and end after completion of composite curing for all bonded teeth.

The duration will be recorded in minutes using a digital stopwatch by an independent assessor using a digital stopwatch (minutes)
Periprocedural (during retainer bonding procedure on Day 1)
wire breakage
Time Frame: Every 3months for 12 months
Every 3months for 12 months
plaque accumulation
Time Frame: Baseline (before retainer bonding) and at 3, 6, 9, and 12 months

Plaque accumulation will be assessed using the Silness-Löe Plaque Index, which scores plaque presence on the tooth surface adjacent to the fixed retainer.

Each tooth will be scored on a scale from 0 to 3:

0: No plaque

  1. Thin film of plaque detectable by probe
  2. Moderate accumulation visible to the naked eye
  3. Abundant plaque accumulation

Assessment will be performed by direct intraoral clinical examination using a dental mirror and probe by a calibrated examiner.

The outcome will be reported as the mean plaque index score per patient at each time point.
Baseline (before retainer bonding) and at 3, 6, 9, and 12 months
posttreatment relapse
Time Frame: Baseline (before retainer bonding) and at 12 months

Post-treatment relapse will be assessed using Little's Irregularity Index, which measures the linear displacement of the anatomic contact points of the mandibular anterior teeth.

Relapse will be calculated as the difference in Little's Irregularity Index between baseline (pre-retention) and 12 months follow-up.
Baseline (before retainer bonding) and at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amany Ibrahim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ortho332
  • 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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