Bond, PairNCT07538869
Comparison of 3D Printed Metal Fixed Retainer Versus Conventional Fixed Bonded Retainer
A study testing bar 3d printed metal fixed retainer and conventional fixed retainer in people with Bond, Pair, run by Amany Ibrahim at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Bond, Pair
- What is being tested?
- bar 3d printed metal fixed retainer and conventional fixed retainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bond, Pair
- Being tested
- bar 3d printed metal fixed retainer, conventional fixed retainer
- Medical subject headings
- Pair Bond
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bar 3d printed metal fixed retainerDevice
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.
conventional fixed retainerDevice
Participants will receive a conventional fixed bonded lingual retainer (canine-to-canine) fabricated using multistranded stainless steel wire and bonded using standard clinical procedures.
| Study group | Role | What they receive |
|---|---|---|
| Conventional fixed bonded retainer | Active comparator | Not described Receives: Device: conventional fixed retainer |
| Bar 3d printed metal fixed retainer | Experimental | Not described Receives: Device: bar 3d printed metal fixed retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
bond failure
Bond failure will be assessed clinically by detecting any detachment of the retainer from the tooth surface (number of debonded teeth).
Measured: immediate (within 24 hours after bonding) and at 3, 6, 9, and 12 months
Secondary outcomes (4)
chairside time
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)
Measured: Periprocedural (during retainer bonding procedure on Day 1)
wire breakage
Measured: Every 3months for 12 months
plaque accumulation
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
- Thin film of plaque detectable by probe
- Moderate accumulation visible to the naked eye
- 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.
Measured: Baseline (before retainer bonding) and at 3, 6, 9, and 12 months
posttreatment relapse
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.
Measured: Baseline (before retainer bonding) and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Apr 2025
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bond, PairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amany Ibrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amany Ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538869
- Sponsor's protocol ID
- Ortho332
- Other IDs
- Cairo University
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 3D Printed Metal Fixed Retainer Versus Conventional Fixed Bonded Retainer
- ClinicalTrials.gov ID
- NCT07538869
- Acronym / sponsor ID
- Ortho332
- Conditions
- Bond, Pair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Amany IbrahimUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional fixed bonded retainer | Active comparator | Device: conventional fixed retainer |
| Bar 3d printed metal fixed retainer | Experimental | Device: bar 3d printed metal fixed retainer |
Who may qualify
- Ages
- 13 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bar 3d printed metal fixed retainerParticipants 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. | Device | Bar 3d printed metal fixed retainer |
| conventional fixed retainerParticipants will receive a conventional fixed bonded lingual retainer (canine-to-canine) fabricated using multistranded stainless steel wire and bonded using standard clinical procedures. | Device | Conventional fixed bonded retainer |
Primary outcome
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).
4 secondary outcomes
chairside time
Time frame: Periprocedural (during retainer bonding procedure on Day 1)
wire breakage
Time frame: Every 3months for 12 months
plaque accumulation
Time frame: Baseline (before retainer bonding) and at 3, 6, 9, and 12 months
posttreatment relapse
Time frame: Baseline (before retainer bonding) and at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bar 3d printed metal fixed retainer and conventional fixed retainer in people with Bond, Pair, run by Amany Ibrahim at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bond failure (time frame: immediate (within 24 hours after bonding) and at 3, 6, 9, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.