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

NCT05926934 | Active Not Recruiting

• 1 other identifier: 409/08.02.2022
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapse; Orthodontic Retention

Outcome Measures

Primary Outcomes (20)

• 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 Outcomes (12)

• 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

Study Arms (3)

Single strand β-Ti fixed retainer

EXPERIMENTAL

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

SS fixed retainer

EXPERIMENTAL

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

Device: Experimental: SS fixed retainer

Twisted fixed retainer

EXPERIMENTAL

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

Device: Experimental: Twisted fixed retainer

Interventions

Experimental: Single strand β-Ti fixed retainer DEVICE

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.

Single strand β-Ti fixed retainer

Experimental: SS fixed retainer DEVICE

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.

SS fixed retainer

Experimental: Twisted fixed retainer DEVICE

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.

Twisted fixed retainer

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

National and Kapodistrian University of Athens, School of Dentistry, Departments of Orthodontics

Athens, Attica, 11527, Greece

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: July 3, 2023
• Study Start: January 16, 2022
• Primary Completion: June 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)