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

NCT ID: NCT02742493

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-16

Study Completion Date

2025-11-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Relapse Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0.028 bonded to canines

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

Group Type EXPERIMENTAL

0.028 bonded to canines

Intervention Type OTHER

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 6

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

Group Type EXPERIMENTAL

0.027 7-strand bonded to all 6

Intervention Type OTHER

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-type

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

Group Type ACTIVE_COMPARATOR

removable Hawley-type

Intervention Type OTHER

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

Interventions

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0.028 bonded to canines

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

Intervention Type OTHER

0.027 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)

Intervention Type OTHER

removable Hawley-type

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

Intervention Type OTHER

Eligibility Criteria

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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

* No missing teeth, impacted teeth or other dental anomalies
* No congenital anomalies/ syndromes
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Iosif Sifakakis

Associate Prof., Department of Orthodontics, School of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iosif Sifakakis, Lecturer

Role: PRINCIPAL_INVESTIGATOR

National and Kapodistrian University of Athens

Locations

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Department of Orthodontics, School of Dentistry, University of Athens

Athens, Goudi, Greece

Site Status

Countries

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Greece

Other Identifiers

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294

Identifier Type: -

Identifier Source: org_study_id

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