Comparison of 3D Printed Resin Fixed Mandibular Retainer Versus Conventional Fixed Bonded Retainer

April 20, 2026 updated by: Raghda Alaa

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

Although there are many studies in the literature concerning with methods of bonding of mandibular retainers whether directly or indirectly, there is a very limited evidence regarding their chair side time and bond failure. Also there are scarce data on 3D printed fixed mandibular retainers. Choic

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • 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, Egypt
        • Faculty of Dentistry

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

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

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
Intervention / Treatment
Active Comparator: Conventional fixed retainer
Device: Conventional fixed retainer
Conventional fixed retainer
Experimental: 3d printed resin retainer
Device: Resin fixed retainer
Resin wire as key modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bond failure
Time Frame: Baseline to 12 months
Primary Outcome Bond Failure Measured by number of debonded teeth using clinical examination and during follow ups Time Frame: Immediately after bonding (baseline visit) till 12 months
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chairside time
Time Frame: During bonding procedure (baseline visit)
Measure: Time required for bonding the fixed retainer Measurement Tool: Digital stopwatch Unit: Seconds Time Frame: During bonding procedure (single visit, baseline)
During bonding procedure (baseline visit)
Plaque accumilation
Time Frame: Every 3 month
Measure: Plaque score around mandibular anterior teeth Measurement Tool: Silness and Löe Plaque Index Unit: Numerical score Time Frame: Baseline ,3 month 6 months and 12 months follow-up
Every 3 month
Wire breakage
Time Frame: Every 3 month till 12 month
Measure: Presence or absence of retainer wire fracture Measurement Tool: Clinical examination Unit: Binary (Yes/No) Time Frame: During 3 month ,6-month and 12 months follow-up period
Every 3 month till 12 month
Posttreatment relapse
Time Frame: After 12 month
Measure: Alignment changes of mandibular anterior teeth Measurement Tool: Little's Irregularity Index Unit: Millimeters (mm) Time Frame: Baseline and12 months follow-up
After 12 month

Collaborators and Investigators

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

Sponsor

Raghda Alaa

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)

February 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Orth332

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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