Comparison of Perforated 3D Printed Versus Conventional Metal Fixed Bonded Retainer
2 other identifiers
interventional
64
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2025
CompletedStudy Start
First participant enrolled
February 14, 2025
CompletedFirst Posted
Study publicly available on registry
February 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
CompletedApril 23, 2026
April 1, 2026
1 year
February 12, 2025
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Bond Failure
Counting number of teeth debonded immediately after placement of wire up to 12 months
immediate up to 12 months
Secondary Outcomes (4)
Chairside Time
Baseline
Plaque accumulation
every 3 months up to 6 months
Wire breakage
every 3 months for 12 months
Post treatment relapse
after 12 months
Study Arms (2)
Conventional fixed retainer
ACTIVE COMPARATORmultistrand or braided metal wire
Perforated 3D printed metal fixed retainer
EXPERIMENTAL3D printed wire custom made to each patient after intraoral scanning
Interventions
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 metal retainer will be used. Multi strand wire will be used
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mariam Alaalead
Study Sites (1)
Cairo University
Giza, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariam MA Elsebaey, Phd
Cairo University
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
February 12, 2025
First Posted
February 28, 2025
Study Start
February 14, 2025
Primary Completion
March 1, 2026
Study Completion
June 1, 2026
Last Updated
April 23, 2026
Record last verified: 2026-04