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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Gingival Recession; Relapse
• Intervention / Treatment: Other: 0.028 bonded to canines; Other: 0.027 7-strand bonded to all 6; Other: removable Hawley-type

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.028 bonded to canines; lower fixed canine and canine retainer and upper removable Hawley (Intervention A)	Other: 0.028 bonded to canines; lower fixed canine and canine retainer (0.028 stainless steel bonded to canines) and upper removable Hawley (Intervention A)
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; lower fixed canine to canine retainer (7-strand Twistflex 0.027 bonded to all six anterior teeth) and upper removable Hawley (Intervention B)
Active Comparator: removable Hawley-type; lower hawley-type and upper hawley removable retainer (Control)	Other: removable Hawley-type; lower Hawley-type and upper Hawley removable retainer (Control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Changes in Overbite and Overjet (mm)	1 year in retention, 2 years in retention, 5 years in retention
Accidental bond failures of fixed retainers or breakages of removable ones	1 year in retention, 2 years in retention, 5 years in retention
Leveling or torque related problems of the lower anterior teeth	1 year in retention, 2 years in retention, 5 years in retention

Collaborators and Investigators

• Sponsor: University of Athens
• Investigators: Principal Investigator: Iosif Sifakakis, Lecturer, National and Kapodistrian University of Athens

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: April 14, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: relapse; retention; irregularity; recession
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Recurrence; Gingival Recession
• Other Study ID Numbers: 294

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes