NCT02742493

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

January 14, 2025

Status Verified

August 1, 2023

Enrollment Period

9.3 years

First QC Date

April 14, 2016

Last Update Submit

January 10, 2025

Conditions

RelapseGingival Recession

Keywords

relapseirregularityrecessionretention

Outcome Measures

Primary Outcomes (5)

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

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

  • Changes in Intercanine width in the mandible (mm)

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

  • Changes in Interpremolar width in the mandible (mm)

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

  • Changes in Intermolar width in the mandible (mm)

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

  • Changes in Arch length in the mandible (mm)

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

Secondary Outcomes (8)

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

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

  • Changes in Intercanine width in the maxilla (mm)

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

  • Changes in Interpremolar width in the maxilla (mm)

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

  • Changes in Intermolar width in the maxilla (mm)

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

  • Changes in Arch length in the maxilla (mm)

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

  • +3 more secondary outcomes

Study Arms (3)

0.028 bonded to canines

EXPERIMENTAL

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

Other: 0.028 bonded to canines

0.027 7-strand bonded to all 6

EXPERIMENTAL

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

Other: 0.027 7-strand bonded to all 6

removable Hawley-type

ACTIVE COMPARATOR

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

Other: removable Hawley-type

Interventions

0.028 bonded to caninesOTHER

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

0.028 bonded to canines
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)

0.027 7-strand bonded to all 6
removable Hawley-typeOTHER

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

removable Hawley-type

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics, School of Dentistry, University of Athens

Athens, Goudi, 11527, Greece

Location

MeSH Terms

Conditions

RecurrenceGingival Recession

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Iosif Sifakakis, Lecturer

    National and Kapodistrian University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof., Department of Orthodontics, School of Dentistry

Study Record Dates

First Submitted

April 14, 2016

First Posted

April 19, 2016

Study Start

March 16, 2016

Primary Completion

June 30, 2025

Study Completion

November 1, 2025

Last Updated

January 14, 2025

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

Locations

GR(1)