Bond, PairNCT06851897
Comparison of Perforated 3D Printed Versus Conventional Metal Fixed Bonded Retainer
A study testing perforated 3D printed metal fixed retainer and conventional fixed retainer in people with Bond, Pair, run by Mariam Alaa at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Bond, Pair
- What is being tested?
- perforated 3D printed metal fixed retainer and conventional fixed retainer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Feb 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Perforated 3D Printed Metal Fixed Mandibular Retainer Versus Conventional Fixed Bonded Retainer A Randomized Clinical Trial
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.
Read the detailed description
In recent years a new possibility is available for dental practitioners: CAD-CAM technology and 3D printing, which find their application in all aspects of orthodontics. Orthodontists are already familiar with several products that use 3D printers (i.e. invisible aligners), also known as additive manufacturing, 3D printing is a technology whereby sequential layers of material are layered on top of one another to form an object23. Two recent articles reported the fabrication of a custom lingual retainer cut from a nickel-titanium block with CAD/CAM technology and a CAD/CAM Zirconium bar as a bonded mandibular fixed retainer.
- Conditions
- Bond, Pair
- Being tested
- perforated 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.
perforated 3D printed metal fixed retainerOther
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 retainerOther
Conventional fixed metal retainer will be used. Multi strand wire will be used
| Study group | Role | What they receive |
|---|---|---|
| Conventional fixed retainer | Active comparator | multistrand or braided metal wire Receives: Other: conventional fixed retainer |
| Perforated 3D printed metal fixed retainer | Experimental | 3D printed wire custom made to each patient after intraoral scanning Receives: Other: perforated 3D printed metal fixed retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bond Failure
Counting number of teeth debonded immediately after placement of wire up to 12 months
Measured: immediate up to 12 months
Secondary outcomes (4)
Chairside Time
Measured: Baseline
Plaque accumulation
By using Loe \& Silness plaque index to go give score for each tooth.
Measured: every 3 months up to 6 months
Wire breakage
Through detecting (by naked eye) any breakage in fixed retainer wire intrarally.
Measured: every 3 months for 12 months
Post treatment relapse
By using Little irregularity index to detect any teeth irregularity that may occur starting from placement of wire till 12 months.
Measured: after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start14 Feb 2025
- Primary completion1 Mar 2026
- Study completion1 Jun 2026 (estimated)
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 (estimated)
Sponsor and investigators
- Lead sponsor
- Mariam Alaa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mariam Alaa, Cairo University
- Investigators
- Mariam MA Elsebaey, Phd, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851897
- Sponsor's protocol ID
- Orth 332
- Other IDs
- Cairo University
- Status last verified
- Apr 2026
- First submitted
- 12 Feb 2025
- Last updated
- 23 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perforated 3D Printed Metal Fixed Mandibular Retainer Versus Conventional Fixed Bonded Retainer A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06851897
- Acronym / sponsor ID
- Orth 332
- Conditions
- Bond, Pair
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Mariam AlaaUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 28 Feb 2025 (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.
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.
Detailed description
In recent years a new possibility is available for dental practitioners: CAD-CAM technology and 3D printing, which find their application in all aspects of orthodontics. Orthodontists are already familiar with several products that use 3D printers (i.e. invisible aligners), also known as additive manufacturing, 3D printing is a technology whereby sequential layers of material are layered on top of one another to form an object23. Two recent articles reported the fabrication of a custom lingual retainer cut from a nickel-titanium block with CAD/CAM technology and a CAD/CAM Zirconium bar as a bonded mandibular fixed retainer.
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 retainer | Active comparator | Other: conventional fixed retainermultistrand or braided metal wire |
| Perforated 3D printed metal fixed retainer | Experimental | Other: perforated 3D printed metal fixed retainer3D printed wire custom made to each patient after intraoral scanning |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| perforated 3D printed metal fixed retainerThe 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. | Other | Perforated 3D printed metal fixed retainer |
| conventional fixed retainerConventional fixed metal retainer will be used. Multi strand wire will be used | Other | Conventional fixed retainer |
Primary outcome
Bond Failure
Time frame: immediate up to 12 months
Counting number of teeth debonded immediately after placement of wire up to 12 months
4 secondary outcomes
Chairside Time
Time frame: Baseline
Plaque accumulation
Time frame: every 3 months up to 6 months
Wire breakage
Time frame: every 3 months for 12 months
Post treatment relapse
Time frame: after 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Related trials for Bond, Pair
Active, not recruiting
Comparison of 3D Printed Resin Fixed Mandibular Retainer Versus Conventional Fixed Bonded Retainer
Bond Pair
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.
Mariam MA Elsebaey, Phd principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perforated 3D printed metal fixed retainer and conventional fixed retainer in people with Bond, Pair, run by Mariam Alaa 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 5 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: under way, not looking for participants, as of the sponsor's last update on 23 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?
This study is still under way. Results are not available in the source record yet.
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 up to 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 23 Apr 2026.