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

Relapse Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05926934
• Other study ID #: 409/08.02.2022
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2022
• Est. completion date: November 2024

Study information

• Verified date: June 2023
• Source: University of Athens
• Contact: Iosif Sifakakis, Associate Professor
• Phone: 210 74612278
• Email: isifak[@]dent.uoa.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Recurrence
• Relapse

Intervention

Device:
• Experimental: Single strand ß-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
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
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.

Locations

Country	Name	City	State
Greece	National and Kapodistrian University of Athens, School of Dentistry, Departments of Orthodontics	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of teeth that failed regarding the bonding strength		baseline-3 months
Primary	Number of teeth that failed regarding the bonding strength		3 months-6 months
Primary	Number of teeth that failed regarding the bonding strength		6 months-9 months
Primary	Number of teeth that failed regarding the bonding strength		9 months-1 year
Primary	Repeatability of bonding strength failure per patient and per tooth		baseline-3 months
Primary	Repeatability of bonding strength failure per patient and per tooth		3 months-6 months
Primary	Repeatability of bonding strength failure per patient and per tooth		6 months-9months
Primary	Repeatability of bonding strength failure per patient and per tooth		9months-1 year
Primary	Breakage of fixed retainer wires		baseline-3 months
Primary	Breakage of fixed retainer wires		3 months-6 months
Primary	Breakage of fixed retainer wires		6 months-9 months
Primary	Breakage of fixed retainer wires		9 months-1 year
Primary	Space discrepancy (Little index)(in mm)		baseline-3 months
Primary	Space discrepancy (Little index)(in mm)		3 months-6 months
Primary	Space discrepancy (Little index)(in mm)		6 months-9 months
Primary	Space discrepancy (Little index)(in mm)		9 months-1 year
Primary	Mandibular intercanine distance		baseline-3 months
Primary	Mandibular intercanine distance		3 months-6 months
Primary	Mandibular intercanine distance		6 months-9 months
Primary	Mandibular arch length (in mm)		9 months-1 year
Secondary	Tooth rotations in lower anterior teeth		baseline-3 months
Secondary	Tooth rotations in lower anterior teeth		3 months-6 months
Secondary	Tooth rotations in lower anterior teeth		6 months-9 months
Secondary	Tooth rotations in lower anterior teeth		9 months-1 year
Secondary	Extrusion in lower anterior teeth		baseline-3 months
Secondary	Extrusion in lower anterior teeth		3 months-6 months
Secondary	Extrusion in lower anterior teeth		6 months-9 months
Secondary	Extrusion in lower anterior teeth		9 months-1 year
Secondary	Tip inclinations anteroposteriorly		baseline-3 months
Secondary	Tip inclinations anteroposteriorly		3 months-6 months
Secondary	Tip inclinations anteroposteriorly		6 months-9 months
Secondary	Tip inclinations anteroposteriorly		9 months -1 year