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

Primary Purpose

Relapse, Orthodontic Retention

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Experimental: Single strand β-Ti fixed retainer
Experimental: SS fixed retainer
Experimental: Twisted fixed retainer
Sponsored by
University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapse

Eligibility Criteria

13 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National and Kapodistrian University of Athens, School of Dentistry, Departments of OrthodonticsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Single strand β-Ti fixed retainer

SS fixed retainer

Twisted fixed retainer

Arm Description

Single strand β-Ti fixed retainer 0.011in diameter, bonded on each tooth separately from #33-43

SS fixed retainer 0.028in diameter, bonded on each tooth separately from #33-43

Twisted fixed retainer 0.027in diameter, bonded on each tooth separately from #33-43

Outcomes

Primary Outcome Measures

Number of teeth that failed regarding the bonding strength
Number of teeth that failed regarding the bonding strength
Number of teeth that failed regarding the bonding strength
Number of teeth that failed regarding the bonding strength
Repeatability of bonding strength failure per patient and per tooth
Repeatability of bonding strength failure per patient and per tooth
Repeatability of bonding strength failure per patient and per tooth
Repeatability of bonding strength failure per patient and per tooth
Breakage of fixed retainer wires
Breakage of fixed retainer wires
Breakage of fixed retainer wires
Breakage of fixed retainer wires
Space discrepancy (Little index)(in mm)
Space discrepancy (Little index)(in mm)
Space discrepancy (Little index)(in mm)
Space discrepancy (Little index)(in mm)
Mandibular intercanine distance
Mandibular intercanine distance
Mandibular intercanine distance
Mandibular arch length (in mm)

Secondary Outcome Measures

Tooth rotations in lower anterior teeth
Tooth rotations in lower anterior teeth
Tooth rotations in lower anterior teeth
Tooth rotations in lower anterior teeth
Extrusion in lower anterior teeth
Extrusion in lower anterior teeth
Extrusion in lower anterior teeth
Extrusion in lower anterior teeth
Tip inclinations anteroposteriorly
Tip inclinations anteroposteriorly
Tip inclinations anteroposteriorly
Tip inclinations anteroposteriorly

Full Information

First Posted
May 31, 2023
Last Updated
June 29, 2023
Sponsor
University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT05926934
Brief Title
The Effectiveness of 3 Orthodontic Fixed 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 Bond Failures and the Effectiveness of Three Orthodontic Retention Schemes in Preventing Post-treatment Mandibular Arch Changes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single strand β-Ti fixed retainer
Arm Type
Experimental
Arm Description
Single strand β-Ti fixed retainer 0.011in diameter, bonded on each tooth separately from #33-43
Arm Title
SS fixed retainer
Arm Type
Experimental
Arm Description
SS fixed retainer 0.028in diameter, bonded on each tooth separately from #33-43
Arm Title
Twisted fixed retainer
Arm Type
Experimental
Arm Description
Twisted fixed retainer 0.027in diameter, bonded on each tooth separately from #33-43
Intervention Type
Device
Intervention Name(s)
Experimental: Single strand β-Ti fixed retainer
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Experimental: SS fixed retainer
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Experimental: Twisted fixed retainer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of teeth that failed regarding the bonding strength
Time Frame
baseline-3 months
Title
Number of teeth that failed regarding the bonding strength
Time Frame
3 months-6 months
Title
Number of teeth that failed regarding the bonding strength
Time Frame
6 months-9 months
Title
Number of teeth that failed regarding the bonding strength
Time Frame
9 months-1 year
Title
Repeatability of bonding strength failure per patient and per tooth
Time Frame
baseline-3 months
Title
Repeatability of bonding strength failure per patient and per tooth
Time Frame
3 months-6 months
Title
Repeatability of bonding strength failure per patient and per tooth
Time Frame
6 months-9months
Title
Repeatability of bonding strength failure per patient and per tooth
Time Frame
9months-1 year
Title
Breakage of fixed retainer wires
Time Frame
baseline-3 months
Title
Breakage of fixed retainer wires
Time Frame
3 months-6 months
Title
Breakage of fixed retainer wires
Time Frame
6 months-9 months
Title
Breakage of fixed retainer wires
Time Frame
9 months-1 year
Title
Space discrepancy (Little index)(in mm)
Time Frame
baseline-3 months
Title
Space discrepancy (Little index)(in mm)
Time Frame
3 months-6 months
Title
Space discrepancy (Little index)(in mm)
Time Frame
6 months-9 months
Title
Space discrepancy (Little index)(in mm)
Time Frame
9 months-1 year
Title
Mandibular intercanine distance
Time Frame
baseline-3 months
Title
Mandibular intercanine distance
Time Frame
3 months-6 months
Title
Mandibular intercanine distance
Time Frame
6 months-9 months
Title
Mandibular arch length (in mm)
Time Frame
9 months-1 year
Secondary Outcome Measure Information:
Title
Tooth rotations in lower anterior teeth
Time Frame
baseline-3 months
Title
Tooth rotations in lower anterior teeth
Time Frame
3 months-6 months
Title
Tooth rotations in lower anterior teeth
Time Frame
6 months-9 months
Title
Tooth rotations in lower anterior teeth
Time Frame
9 months-1 year
Title
Extrusion in lower anterior teeth
Time Frame
baseline-3 months
Title
Extrusion in lower anterior teeth
Time Frame
3 months-6 months
Title
Extrusion in lower anterior teeth
Time Frame
6 months-9 months
Title
Extrusion in lower anterior teeth
Time Frame
9 months-1 year
Title
Tip inclinations anteroposteriorly
Time Frame
baseline-3 months
Title
Tip inclinations anteroposteriorly
Time Frame
3 months-6 months
Title
Tip inclinations anteroposteriorly
Time Frame
6 months-9 months
Title
Tip inclinations anteroposteriorly
Time Frame
9 months -1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iosif Sifakakis, Associate Professor
Phone
210 74612278
Email
isifak@dent.uoa.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Panagiotis Roulias, Researcher
Email
rouliaspanagiotis@gmail.com
Facility Information:
Facility Name
National and Kapodistrian University of Athens, School of Dentistry, Departments of Orthodontics
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iosif Sifakakis, Ass. Prof.
Phone
00302107461228
Email
isifak@dent.uoa.gr

12. IPD Sharing Statement

Learn more about this trial

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

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