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

NCT ID: NCT05926934

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-16
• Study Completion Date: 2025-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single strand β-Ti fixed retainer

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

Group Type: EXPERIMENTAL

Experimental: Single strand β-Ti fixed retainer

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Experimental: SS fixed retainer

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Experimental: Twisted fixed retainer

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Iosif Sifakakis

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Athens, Attica, Greece

Countries

Greece

Other Identifiers

409/08.02.2022

Identifier Type: -

Identifier Source: org_study_id