The Effectiveness of 3 Orthodontic Fixed Retention Schemes on Post-treatment Stability and Gingival Recession (OrthRe10tion)

January 3, 2025 updated by: Iosif Sifakakis, University of Athens

A Single-center, 3-arm, Parallel-group Randomized Controlled Trial to Evaluate Bond Failures and the Effectiveness of Three Orthodontic Retention Schemes in Preventing Post-treatment Mandibular Arch Changes

There is high possibility of relapse of the lower anterior teeth after orthodontic treatment. Relapse is related with the initial orthodontic anomaly, pathology of surrounding tissues, patient's age and sex and compliance and the retention protocol applied. The options for the later are various. Permanent fixed retainers are considered of the most common ones and vastly vary based of composition. There are fixed retainers distinguished for their composition (SS, β-NiTi, fiber-reinforced composite retainers) or for their shape and dimensions (round or rectangular shape and single-strand or multi-strand respectively), and/or for the teeth they are placed on (canine and canine or canine to canine). Fixed retainers may require patient's cooperation , nevertheless debond failure rate varies between 0.1-53%.

The aim of this prospective randomized clinical study is to compare failure incidents and retention effect on lower anterior teeth after orthodontic finish between three different types of fixed retainers. There will be 3 arms studied in this research: a) single strand 0.016x0.022'' β-Ti canine to canine, b) 0.028'' SS canine to canine and c) 0.027'' multi-strand twistflex canine to canine. Variables such as repeatability of failures, and undesired tooth movements will be measured. Measurements will be repeated every 3 months after patient's recruitment in this study, for one year period (12 months in total). Intraoral scans will be collected during baseline (fixed retainer insertion) and after 12 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Iosif Sifakakis, Associate Professor
  • Phone Number: 210 74612278
  • Email: isifak@dent.uoa.gr

Study Contact Backup

Study Locations

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 11527
        • National and Kapodistrian University of Athens, School of Dentistry, Departments of Orthodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients treated with fixed orthodontic appliances (Roth 0.018'' slot at their final finishing stage)
  • Patients with fixed orthodontic appliances at least between their lower first premolars
  • No lower anterior teeth crowding (total irregularity index score = 0)
  • Patients with no need of removable retention appliances on their lower teeth

Exclusion Criteria:

  • Active caries on adjacent or lingual surfaces of lower anterior teeth
  • Active periodontitis
  • Supragingival calculus
  • Gum bleeding during bonding of fixed retainer
  • Gingival pocket depth greater than 3mm
  • Syndromes or other anomalies of the craniofacial complex or other mental illness
  • Missing or impacted teeth or other dental anomalies
  • Congenital anomalies/syndromes
  • Allergies regarding the alloys of fixed retainers
  • Need for chemoprevention before data collection of periodontal indexes
  • Diabetes
  • Smoking
  • Usage of antibiotics
  • Pregnancy
  • Participation in other clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single strand β-Ti fixed retainer
Single strand β-Ti fixed retainer 0.011in diameter, bonded on each tooth separately from #33-43
Device: Experimental: Single strand β-Ti fixed retainer
All 90 patients between 13-30 y.o. treated with fixed orthodontic appliances (Roth 0.018'' slot at their final finishing stage) on at least between their lower first premolars and with no lower anterior teeth crowding (total irregularity index score = 0) and no need of removable retention appliances on their lower teeth, were randomly assigned to one of the three experimental groups.
Experimental: SS fixed retainer
SS fixed retainer 0.028in diameter, bonded on each tooth separately from #33-43
Device: Experimental: SS fixed retainer
All 90 patients between 13-30 y.o. treated with fixed orthodontic appliances (Roth 0.018'' slot at their final finishing stage) on at least between their lower first premolars and with no lower anterior teeth crowding (total irregularity index score = 0) and no need of removable retention appliances on their lower teeth, were randomly assigned to one of the three experimental groups.
Experimental: Twisted fixed retainer
Twisted fixed retainer 0.027in diameter, bonded on each tooth separately from #33-43
Device: Experimental: Twisted fixed retainer
All 90 patients between 13-30 y.o. treated with fixed orthodontic appliances (Roth 0.018'' slot at their final finishing stage) on at least between their lower first premolars and with no lower anterior teeth crowding (total irregularity index score = 0) and no need of removable retention appliances on their lower teeth, were randomly assigned to one of the three experimental groups.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of teeth that failed regarding the bonding strength
Time Frame: baseline-3 months
baseline-3 months
Number of teeth that failed regarding the bonding strength
Time Frame: 3 months-6 months
3 months-6 months
Number of teeth that failed regarding the bonding strength
Time Frame: 6 months-9 months
6 months-9 months
Number of teeth that failed regarding the bonding strength
Time Frame: 9 months-1 year
9 months-1 year
Repeatability of bonding strength failure per patient and per tooth
Time Frame: baseline-3 months
baseline-3 months
Repeatability of bonding strength failure per patient and per tooth
Time Frame: 3 months-6 months
3 months-6 months
Repeatability of bonding strength failure per patient and per tooth
Time Frame: 6 months-9months
6 months-9months
Repeatability of bonding strength failure per patient and per tooth
Time Frame: 9months-1 year
9months-1 year
Breakage of fixed retainer wires
Time Frame: baseline-3 months
baseline-3 months
Breakage of fixed retainer wires
Time Frame: 3 months-6 months
3 months-6 months
Breakage of fixed retainer wires
Time Frame: 6 months-9 months
6 months-9 months
Breakage of fixed retainer wires
Time Frame: 9 months-1 year
9 months-1 year
Space discrepancy (Little index)(in mm)
Time Frame: baseline-3 months
baseline-3 months
Space discrepancy (Little index)(in mm)
Time Frame: 3 months-6 months
3 months-6 months
Space discrepancy (Little index)(in mm)
Time Frame: 6 months-9 months
6 months-9 months
Space discrepancy (Little index)(in mm)
Time Frame: 9 months-1 year
9 months-1 year
Mandibular intercanine distance
Time Frame: baseline-3 months
baseline-3 months
Mandibular intercanine distance
Time Frame: 3 months-6 months
3 months-6 months
Mandibular intercanine distance
Time Frame: 6 months-9 months
6 months-9 months
Mandibular arch length (in mm)
Time Frame: 9 months-1 year
9 months-1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Tooth rotations in lower anterior teeth
Time Frame: baseline-3 months
baseline-3 months
Tooth rotations in lower anterior teeth
Time Frame: 3 months-6 months
3 months-6 months
Tooth rotations in lower anterior teeth
Time Frame: 6 months-9 months
6 months-9 months
Tooth rotations in lower anterior teeth
Time Frame: 9 months-1 year
9 months-1 year
Extrusion in lower anterior teeth
Time Frame: baseline-3 months
baseline-3 months
Extrusion in lower anterior teeth
Time Frame: 3 months-6 months
3 months-6 months
Extrusion in lower anterior teeth
Time Frame: 6 months-9 months
6 months-9 months
Extrusion in lower anterior teeth
Time Frame: 9 months-1 year
9 months-1 year
Tip inclinations anteroposteriorly
Time Frame: baseline-3 months
baseline-3 months
Tip inclinations anteroposteriorly
Time Frame: 3 months-6 months
3 months-6 months
Tip inclinations anteroposteriorly
Time Frame: 6 months-9 months
6 months-9 months
Tip inclinations anteroposteriorly
Time Frame: 9 months -1 year
9 months -1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 409/08.02.2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings