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Status unknownNCT02742493OrthRe10tionUpdated Jan 14, 2025

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

An interventional study of 0.028 bonded to canines and 0.027 7-strand bonded to all 6 in Relapse and Gingival Recession, sponsored by University of Athens. Status unknown at 1 site in Greece. Open to participants aged 10 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by University of Athens · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
10 Years to 16 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Relapse
  • Gingival Recession

Keywords

  • relapse
  • irregularity
  • recession
  • retention
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In context

Recurrence

4,349 studies on the registry are indexed under Recurrence; 1,004 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 3,429 interventional studies indexed under Recurrence.

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Lead sponsor

University of Athens is the lead sponsor of 139 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • No missing teeth, impacted teeth or other dental anomalies
  • No congenital anomalies/ syndromes
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    0.028 bonded to canines

    lower fixed canine and canine retainer and upper removable Hawley (Intervention A)

    Other: 0.028 bonded to canines

  • Experimental
    0.027 7-strand bonded to all 6

    lower fixed canine to canine retainer and upper removable Hawley (Intervention B)

    Other: 0.027 7-strand bonded to all 6

  • Active comparator
    removable Hawley-type

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

    Other: removable Hawley-type

Interventions

  • Other0.028 bonded to canines

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

  • Other0.027 7-strand bonded to all 6

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

  • Otherremovable Hawley-type

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

06

What researchers measure

Primary outcomes

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

    Time frame: 1 year in retention, 2 years in retention, 5 years in retention

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

    Time frame: 1 year in retention, 2 years in retention, 5 years in retention

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

    Time frame: 1 year in retention, 2 years in retention, 5 years in retention

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

    Time frame: 1 year in retention, 2 years in retention, 5 years in retention

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

    Time frame: 1 year in retention, 2 years in retention, 5 years in retention

Secondary outcomes

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

    Time frame: 1 year in retention, 2 years in retention, 5 years in retention

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

    Time frame: 1 year in retention, 2 years in retention, 5 years in retention

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

    Time frame: 1 year in retention, 2 years in retention, 5 years in retention

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

    Time frame: 1 year in retention, 2 years in retention, 5 years in retention

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

    Time frame: 1 year in retention, 2 years in retention, 5 years in retention

  6. Changes in Overbite and Overjet (mm)

    Time frame: 1 year in retention, 2 years in retention, 5 years in retention

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

    Time frame: 1 year in retention, 2 years in retention, 5 years in retention

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

    Time frame: 1 year in retention, 2 years in retention, 5 years in retention

07

Study locations

1 site
  • Department of Orthodontics, School of Dentistry, University of Athens
    Athens, Goudi 11527, Greece
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02742493
Responsible party
Iosif Sifakakis (Associate Prof., Department of Orthodontics, School of Dentistry, University of Athens) — Principal investigator
First posted
Apr 19, 2016
Start date
Mar 16, 2016
Primary completion
Jun 30, 2025 (estimated)
Completion
Nov 1, 2025 (estimated)
Last update
Jan 14, 2025

Study contacts

Iosif Sifakakis, Lecturer
principal investigator · National and Kapodistrian University of Athens

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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