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

Sponsor

University of Athens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05926934

Collaborator

(none)

Enrollment

Location

Arms

33.5

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Relapse Orthodontic Retention	Device: Experimental: Single strand β-Ti fixed retainer Device: Experimental: SS fixed retainer Device: Experimental: Twisted fixed retainer	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 16, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

Experimental: Twisted fixed retainer

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

Device: Experimental: Twisted fixed retainer

Outcome Measures

Primary Outcome Measures

Number of teeth that failed regarding the bonding strength [baseline-3 months]
Number of teeth that failed regarding the bonding strength [3 months-6 months]
Number of teeth that failed regarding the bonding strength [6 months-9 months]
Number of teeth that failed regarding the bonding strength [9 months-1 year]
Repeatability of bonding strength failure per patient and per tooth [baseline-3 months]
Repeatability of bonding strength failure per patient and per tooth [3 months-6 months]
Repeatability of bonding strength failure per patient and per tooth [6 months-9months]
Repeatability of bonding strength failure per patient and per tooth [9months-1 year]
Breakage of fixed retainer wires [baseline-3 months]
Breakage of fixed retainer wires [3 months-6 months]
Breakage of fixed retainer wires [6 months-9 months]
Breakage of fixed retainer wires [9 months-1 year]
Space discrepancy (Little index)(in mm) [baseline-3 months]
Space discrepancy (Little index)(in mm) [3 months-6 months]
Space discrepancy (Little index)(in mm) [6 months-9 months]
Space discrepancy (Little index)(in mm) [9 months-1 year]
Mandibular intercanine distance [baseline-3 months]
Mandibular intercanine distance [3 months-6 months]
Mandibular intercanine distance [6 months-9 months]
Mandibular arch length (in mm) [9 months-1 year]

Secondary Outcome Measures

Tooth rotations in lower anterior teeth [baseline-3 months]
Tooth rotations in lower anterior teeth [3 months-6 months]
Tooth rotations in lower anterior teeth [6 months-9 months]
Tooth rotations in lower anterior teeth [9 months-1 year]
Extrusion in lower anterior teeth [baseline-3 months]
Extrusion in lower anterior teeth [3 months-6 months]
Extrusion in lower anterior teeth [6 months-9 months]
Extrusion in lower anterior teeth [9 months-1 year]
Tip inclinations anteroposteriorly [baseline-3 months]
Tip inclinations anteroposteriorly [3 months-6 months]
Tip inclinations anteroposteriorly [6 months-9 months]
Tip inclinations anteroposteriorly [9 months -1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National and Kapodistrian University of Athens, School of Dentistry, Departments of Orthodontics	Athens	Attiki	Greece	11527

Sponsors and Collaborators

University of Athens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Iosif Sifakakis, Associate Professor, University of Athens

ClinicalTrials.gov Identifier:

NCT05926934

Other Study ID Numbers:

409/08.02.2022

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 3, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Recurrence

Study Results

No Results Posted as of Jul 3, 2023