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RelapseOrthRe10tionNCT02742493

RCT for the Effectiveness of 3 Orthodontic Retention Schemes on Post-treatment Stability and Gingival Recession

A study testing 0.028 bonded to canines, 0.027 7-strand bonded to all 6 and removable Hawley-type in people with Relapse and Gingival Recession, run by University of Athens at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The present study aims to assess the effectiveness of three different retention schemes used to maintain tooth position after orthodontic treatment with fixed orthodontic appliances (stability) and to evaluate possible association between retention scheme and gingival recessions on the lingual surfaces of the lower… Read more about this study

Who is it for?
Ages 10 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Relapse, Gingival Recession
What is being tested?
0.028 bonded to canines, 0.027 7-strand bonded to all 6 and removable Hawley-type
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteGreece
Study dates
16 Mar 2016to 1 Nov 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 10 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Both sexes
  • Age between 10 and 16 years
  • At the finishing stage of orthodontic treatment, programmed for debonding
  • Class I to Class II molar relationship before the beginning of orthodontic treatment
  • Non-extraction treatment plan with fixed straight-wire appliances
  • Space deficiencies and irregularity of no more than 6mm in the maxillary/ mandibular arch (Irregularity Index)

Who cannot join

  • No missing teeth, impacted teeth or other dental anomalies
  • No congenital anomalies/ syndromes

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Department of Orthodontics, School of Dentistry, University of Athens

    Athens, Goudi, 11527

Other trials in Greece

About this study

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

The present study aims to assess the effectiveness of three different retention schemes used to maintain tooth position after orthodontic treatment with fixed orthodontic appliances (stability) and to evaluate possible association between retention scheme and gingival recessions on the lingual surfaces of the lower anterior teeth seen for up to 5 years post-treatment. Moreover the possible association between primary relapse tendency and long term occlusal stability will be evaluated.

Read the detailed description

This is a randomized, controlled, single-center, equivalence trial with three parallel groups and an allocation ratio of 1:1:1, that aims to investigate the effectiveness of 3 orthodontic retention schemes on post-treatment mandibular arch stability and gingival recession.

Being tested
0.028 bonded to canines, 0.027 7-strand bonded to all 6, removable Hawley-type
Keywords
relapse, irregularity, recession, retention
Medical subject headings
Recurrence, Gingival Recession

What participants receive

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

  • 0.028 bonded to caninesOther

    lower fixed canine and canine retainer (0.028 stainless steel bonded to canines) and upper removable Hawley (Intervention A)

  • 0.027 7-strand bonded to all 6Other

    lower fixed canine to canine retainer (7-strand Twistflex 0.027 bonded to all six anterior teeth) and upper removable Hawley (Intervention B)

  • removable Hawley-typeOther

    lower Hawley-type and upper Hawley removable retainer (Control)

Study groups in NCT02742493
Study groupRoleWhat they receive
0.028 bonded to caninesExperimentallower fixed canine and canine retainer and upper removable Hawley (Intervention A)
Receives: Other: 0.028 bonded to canines
0.027 7-strand bonded to all 6Experimentallower fixed canine to canine retainer and upper removable Hawley (Intervention B)
Receives: Other: 0.027 7-strand bonded to all 6
removable Hawley-typeActive comparatorlower hawley-type and upper hawley removable retainer (Control)
Receives: Other: removable Hawley-type

What is being measured

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

  1. Changes in Little's Irregularity Index in the mandible (mm)

    Measured: 1 year in retention, 2 years in retention, 5 years in retention

  2. Changes in Intercanine width in the mandible (mm)

    Measured: 1 year in retention, 2 years in retention, 5 years in retention

  3. Changes in Interpremolar width in the mandible (mm)

    Measured: 1 year in retention, 2 years in retention, 5 years in retention

  4. Changes in Intermolar width in the mandible (mm)

    Measured: 1 year in retention, 2 years in retention, 5 years in retention

  5. Changes in Arch length in the mandible (mm)

    Measured: 1 year in retention, 2 years in retention, 5 years in retention

Secondary outcomes (8)

  1. Changes in Gingival Recessions on the lingual surfaces of the six lower anterior teeth

    Measured: 1 year in retention, 2 years in retention, 5 years in retention

  2. Changes in Intercanine width in the maxilla (mm)

    Measured: 1 year in retention, 2 years in retention, 5 years in retention

  3. Changes in Interpremolar width in the maxilla (mm)

    Measured: 1 year in retention, 2 years in retention, 5 years in retention

  4. Changes in Intermolar width in the maxilla (mm)

    Measured: 1 year in retention, 2 years in retention, 5 years in retention

  5. Changes in Arch length in the maxilla (mm)

    Measured: 1 year in retention, 2 years in retention, 5 years in retention

  6. Changes in Overbite and Overjet (mm)

    Measured: 1 year in retention, 2 years in retention, 5 years in retention

  7. Accidental bond failures of fixed retainers or breakages of removable ones

    Measured: 1 year in retention, 2 years in retention, 5 years in retention

  8. Leveling or torque related problems of the lower anterior teeth

    Measured: 1 year in retention, 2 years in retention, 5 years in retention

Timeline

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

  1. First posted19 Apr 2016 (estimated)
  2. Study start16 Mar 2016
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion1 Nov 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
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02742493
Sponsor's protocol ID
294
Acronym
OrthRe10tion
Status last verified
Aug 2023
First submitted
14 Apr 2016
Last updated
14 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing 0.028 bonded to canines, 0.027 7-strand bonded to all 6 and removable Hawley-type in people with Relapse and Gingival Recession, 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 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?

Results are not available in the source record.

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?

Changes in Little's Irregularity Index in the mandible (mm) (time frame: 1 year in retention, 2 years in retention, 5 years in retention). The study lists 5 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 NCT02742493.

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 14 Jan 2025.

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