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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05926934
Acronym
OrthRe10tion
Enrollment
90
Registered
2023-07-03
Start date
2022-01-16
Completion date
2025-11-30
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic Retention, Relapse

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.

Interventions

DEVICEExperimental: 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.

DEVICEExperimental: 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.

DEVICEExperimental: 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.

Sponsors

University of Athens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
13 Years to 30 Years
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

Design outcomes

Primary

MeasureTime frame
Mandibular arch length (in mm)9 months-1 year
Breakage of fixed retainer wiresbaseline-3 months
Space discrepancy (Little index)(in mm)baseline-3 months
Mandibular intercanine distancebaseline-3 months
Number of teeth that failed regarding the bonding strengthbaseline-3 months
Repeatability of bonding strength failure per patient and per toothbaseline-3 months

Secondary

MeasureTime frame
Extrusion in lower anterior teethbaseline-3 months
Tip inclinations anteroposteriorlybaseline-3 months
Tooth rotations in lower anterior teethbaseline-3 months

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026