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RCT for the Effectiveness of 3 Orthodontic Retention Schemes on Post-treatment Stability and Gingival Recession (OrthRe10tion)

Primary Purpose

Relapse, Gingival Recession

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

0.028 bonded to canines

0.027 7-strand bonded to all 6

removable Hawley-type

About this trial

This is an interventional treatment trial for Relapse focused on measuring relapse, irregularity, recession, retention

Eligibility Criteria

10 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Orthodontics, School of Dentistry, University of Athens

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

0.028 bonded to canines

0.027 7-strand bonded to all 6

removable Hawley-type

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Changes in Intercanine width in the mandible (mm)

Changes in Interpremolar width in the mandible (mm)

Changes in Intermolar width in the mandible (mm)

Changes in Arch length in the mandible (mm)

Secondary Outcome Measures

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

Changes in Intercanine width in the maxilla (mm)

Changes in Interpremolar width in the maxilla (mm)

Changes in Intermolar width in the maxilla (mm)

Changes in Arch length in the maxilla (mm)

Changes in Overbite and Overjet (mm)

Accidental bond failures of fixed retainers or breakages of removable ones

Leveling or torque related problems of the lower anterior teeth

Full Information

NCT ID

NCT02742493

First Posted

April 14, 2016

Last Updated

May 17, 2022

Sponsor

University of Athens

1. Study Identification

Unique Protocol Identification Number

NCT02742493

Brief Title

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

Acronym

OrthRe10tion

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

April 2016 (undefined)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Athens

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapse, Gingival Recession

Keywords

relapse, irregularity, recession, retention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

0.028 bonded to canines

Arm Type

Experimental

Arm Description

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

Arm Title

0.027 7-strand bonded to all 6

Arm Type

Experimental

Arm Description

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

Arm Title

removable Hawley-type

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

0.028 bonded to canines

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

0.027 7-strand bonded to all 6

Intervention Description

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

Intervention Name(s)

removable Hawley-type

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame