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Bond PairNCT07552155

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

A study testing Resin fixed retainer and Conventional fixed retainer in people with Bond Pair, run by Raghda Alaa at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Bond Pair
What is being tested?
Resin 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 Feb 2025to 1 Jul 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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older 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

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.

Egypt1 site
  • Faculty of dentistry

    Cairo

Other trials in Egypt

About this study

Official title: 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

Conditions
Bond Pair
Being tested
Resin 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.

  • Resin fixed retainerDevice

    Resin wire as key modification

  • Conventional fixed retainerDevice

    Conventional fixed retainer

Study groups in NCT07552155
Study groupRoleWhat they receive
Conventional fixed retainerActive comparatorConventional fixed retainer
Receives: Device: Conventional fixed retainer
3d printed resin retainerExperimentalNot described
Receives: Device: Resin fixed retainer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bond failure

    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

    Measured: Baseline to 12 months

Secondary outcomes (4)
  1. Chairside time

    Measure: Time required for bonding the fixed retainer Measurement Tool: Digital stopwatch Unit: Seconds Time Frame: During bonding procedure (single visit, baseline)

    Measured: During bonding procedure (baseline visit)

  2. Plaque accumilation

    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

    Measured: Every 3 month

  3. Wire breakage

    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

    Measured: Every 3 month till 12 month

  4. Posttreatment relapse

    Measure: Alignment changes of mandibular anterior teeth Measurement Tool: Little's Irregularity Index Unit: Millimeters (mm) Time Frame: Baseline and12 months follow-up

    Measured: After 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2026
  2. Study start1 Feb 2025
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07552155
Sponsor's protocol ID
Orth332
Status last verified
Apr 2026
First submitted
8 Apr 2026
Last updated
27 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Resin fixed retainer and Conventional fixed retainer in people with Bond Pair, run by Raghda 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 27 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: Baseline 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 27 Apr 2026.

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