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

NCT07538869 | Completed DMC

• 2 other identifiers: Ortho332Cairo University
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bond, Pair

Outcome Measures

Primary Outcomes (1)

• bond failure

  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 Outcomes (4)

• chairside time

  Periprocedural (during retainer bonding procedure on Day 1)

• wire breakage

  Every 3months for 12 months

• plaque accumulation

  Baseline (before retainer bonding) and at 3, 6, 9, and 12 months

• posttreatment relapse

  Baseline (before retainer bonding) and at 12 months

Study Arms (2)

Conventional fixed bonded retainer

ACTIVE COMPARATOR

Device: conventional fixed retainer

Bar 3d printed metal fixed retainer

EXPERIMENTAL

Device: bar 3d printed metal fixed retainer

Interventions

bar 3d printed metal fixed retainer DEVICE

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.

Bar 3d printed metal fixed retainer

conventional fixed retainer DEVICE

Participants will receive a conventional fixed bonded lingual retainer (canine-to-canine) fabricated using multistranded stainless steel wire and bonded using standard clinical procedures.

Conventional fixed bonded retainer

Eligibility Criteria

• Age: 13 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Amany Ibrahim: lead

Study Sites (1)

Amany Eltantawy

Giza, Cairo University, Egypt

Location

MeSH Terms

Conditions

Pair Bond

Condition Hierarchy (Ancestors)

Sexual Behavior, Animal; Consummatory Behavior; Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 20, 2026
• Study Start: April 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

EG (1)