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RelapseOrthRe10tionNCT05926934

The Effectiveness of 3 Orthodontic Fixed Retention Schemes on Post-treatment Stability and Gingival Recession

A study testing Experimental: Single strand β-Ti fixed retainer, Experimental: SS fixed retainer and Experimental: Twisted fixed retainer in people with Relapse and Orthodontic Retention, run by University of Athens at 1 site in Greece.

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

There is high possibility of relapse of the lower anterior teeth after orthodontic treatment. Relapse is related with the initial orthodontic anomaly, pathology of surrounding tissues, patient's age and sex and compliance and the retention protocol applied. The options for the later are various. Read more about this study

Who is it for?
Ages 13 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Relapse, Orthodontic Retention
What is being tested?
Experimental: Single strand β-Ti fixed retainer, Experimental: SS fixed retainer and Experimental: Twisted fixed retainer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteGreece
Study dates
16 Jan 2022to Nov 2025
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 13 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Patients treated with fixed orthodontic appliances (Roth 0.018'' slot at their final finishing stage)
  • Patients with fixed orthodontic appliances at least between their lower first premolars
  • No lower anterior teeth crowding (total irregularity index score = 0)
  • Patients with no need of removable retention appliances on their lower teeth

Who cannot join

  • Active caries on adjacent or lingual surfaces of lower anterior teeth
  • Active periodontitis
  • Supragingival calculus
  • Gum bleeding during bonding of fixed retainer
  • Gingival pocket depth greater than 3mm
  • Syndromes or other anomalies of the craniofacial complex or other mental illness
Show all 15Show fewer
  • Missing or impacted teeth or other dental anomalies
  • Congenital anomalies/syndromes
  • Allergies regarding the alloys of fixed retainers
  • Need for chemoprevention before data collection of periodontal indexes
  • Diabetes
  • Smoking
  • Usage of antibiotics
  • Pregnancy
  • Participation in other clinical trials

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • National and Kapodistrian University of Athens, School of Dentistry, Departments of Orthodontics

    Athens, Attica, 11527

Other trials in Greece

About this study

Official title: A Single-center, 3-arm, Parallel-group Randomized Controlled Trial to Evaluate Bond Failures and the Effectiveness of Three Orthodontic Retention Schemes in Preventing Post-treatment Mandibular Arch Changes

There is high possibility of relapse of the lower anterior teeth after orthodontic treatment. Relapse is related with the initial orthodontic anomaly, pathology of surrounding tissues, patient's age and sex and compliance and the retention protocol applied. The options for the later are various. Permanent fixed retainers are considered of the most common ones and vastly vary based of composition. There are fixed retainers distinguished for their composition (SS, β-NiTi, fiber-reinforced composite retainers) or for their shape and dimensions (round or rectangular shape and single-strand or multi-strand respectively), and/or for the teeth they are placed on (canine and canine or canine to canine). Fixed retainers may require patient's cooperation , nevertheless debond failure rate varies between 0.1-53%.

The aim of this prospective randomized clinical study is to compare failure incidents and retention effect on lower anterior teeth after orthodontic finish between three different types of fixed retainers. There will be 3 arms studied in this research: a) single strand 0.016x0.022'' β-Ti canine to canine, b) 0.028'' SS canine to canine and c) 0.027'' multi-strand twistflex canine to canine. Variables such as repeatability of failures, and undesired tooth movements will be measured. Measurements will be repeated every 3 months after patient's recruitment in this study, for one year period (12 months in total). Intraoral scans will be collected during baseline (fixed retainer insertion) and after 12 months.

Being tested
Experimental: Single strand β-Ti fixed retainer, Experimental: SS fixed retainer, Experimental: Twisted fixed retainer
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: Single strand β-Ti fixed retainerDevice

    All 90 patients between 13-30 y.o. treated with fixed orthodontic appliances (Roth 0.018'' slot at their final finishing stage) on at least between their lower first premolars and with no lower anterior teeth crowding (total irregularity index score = 0) and no need of removable retention appliances on their lower teeth, were randomly assigned to one of the three experimental groups.

  • Experimental: SS fixed retainerDevice

    All 90 patients between 13-30 y.o. treated with fixed orthodontic appliances (Roth 0.018'' slot at their final finishing stage) on at least between their lower first premolars and with no lower anterior teeth crowding (total irregularity index score = 0) and no need of removable retention appliances on their lower teeth, were randomly assigned to one of the three experimental groups.

  • Experimental: Twisted fixed retainerDevice

    All 90 patients between 13-30 y.o. treated with fixed orthodontic appliances (Roth 0.018'' slot at their final finishing stage) on at least between their lower first premolars and with no lower anterior teeth crowding (total irregularity index score = 0) and no need of removable retention appliances on their lower teeth, were randomly assigned to one of the three experimental groups.

Study groups in NCT05926934
Study groupRoleWhat they receive
Single strand β-Ti fixed retainerExperimentalSingle strand β-Ti fixed retainer 0.011in diameter, bonded on each tooth separately from #33-43
Receives: Device: Experimental: Single strand β-Ti fixed retainer
SS fixed retainerExperimentalSS fixed retainer 0.028in diameter, bonded on each tooth separately from #33-43
Receives: Device: Experimental: SS fixed retainer
Twisted fixed retainerExperimentalTwisted fixed retainer 0.027in diameter, bonded on each tooth separately from #33-43
Receives: Device: Experimental: Twisted fixed retainer

What is being measured

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

  1. Number of teeth that failed regarding the bonding strength

    Measured: baseline-3 months

  2. Number of teeth that failed regarding the bonding strength

    Measured: 3 months-6 months

  3. Number of teeth that failed regarding the bonding strength

    Measured: 6 months-9 months

  4. Number of teeth that failed regarding the bonding strength

    Measured: 9 months-1 year

  5. Repeatability of bonding strength failure per patient and per tooth

    Measured: baseline-3 months

  6. Repeatability of bonding strength failure per patient and per tooth

    Measured: 3 months-6 months

  7. Repeatability of bonding strength failure per patient and per tooth

    Measured: 6 months-9months

  8. Repeatability of bonding strength failure per patient and per tooth

    Measured: 9months-1 year

  9. Breakage of fixed retainer wires

    Measured: baseline-3 months

  10. Breakage of fixed retainer wires

    Measured: 3 months-6 months

  11. Breakage of fixed retainer wires

    Measured: 6 months-9 months

  12. Breakage of fixed retainer wires

    Measured: 9 months-1 year

  13. Space discrepancy (Little index)(in mm)

    Measured: baseline-3 months

  14. Space discrepancy (Little index)(in mm)

    Measured: 3 months-6 months

  15. Space discrepancy (Little index)(in mm)

    Measured: 6 months-9 months

  16. Space discrepancy (Little index)(in mm)

    Measured: 9 months-1 year

  17. Mandibular intercanine distance

    Measured: baseline-3 months

  18. Mandibular intercanine distance

    Measured: 3 months-6 months

  19. Mandibular intercanine distance

    Measured: 6 months-9 months

  20. Mandibular arch length (in mm)

    Measured: 9 months-1 year

Secondary outcomes (12)

  1. Tooth rotations in lower anterior teeth

    Measured: baseline-3 months

  2. Tooth rotations in lower anterior teeth

    Measured: 3 months-6 months

  3. Tooth rotations in lower anterior teeth

    Measured: 6 months-9 months

  4. Tooth rotations in lower anterior teeth

    Measured: 9 months-1 year

  5. Extrusion in lower anterior teeth

    Measured: baseline-3 months

  6. Extrusion in lower anterior teeth

    Measured: 3 months-6 months

  7. Extrusion in lower anterior teeth

    Measured: 6 months-9 months

  8. Extrusion in lower anterior teeth

    Measured: 9 months-1 year

  9. Tip inclinations anteroposteriorly

    Measured: baseline-3 months

  10. Tip inclinations anteroposteriorly

    Measured: 3 months-6 months

  11. Tip inclinations anteroposteriorly

    Measured: 6 months-9 months

  12. Tip inclinations anteroposteriorly

    Measured: 9 months -1 year

Timeline

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

  1. First posted3 Jul 2023
  2. Study start16 Jan 2022
  3. Primary completionJun 2025 (estimated)
  4. Study completionNov 2025 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05926934
Sponsor's protocol ID
409/08.02.2022
Acronym
OrthRe10tion
Status last verified
Jan 2025
First submitted
31 May 2023
Last updated
6 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Single strand β-Ti fixed retainer, Experimental: SS fixed retainer and Experimental: Twisted fixed retainer in people with Relapse and Orthodontic Retention, run by University of Athens at 1 site in Greece.

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 15 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 6 Jan 2025. 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 Greece. 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?

Number of teeth that failed regarding the bonding strength (time frame: baseline-3 months). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05926934.

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 6 Jan 2025.

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