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NCT Number: NCT05926934

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

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.

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Key information

Conditions

Relapse Disease Attributes Orthodontic Retention Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

13 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Athens, Attica, 11527, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Number of teeth that failed regarding the bonding strength

    Time frame: baseline-3 months

  2. Number of teeth that failed regarding the bonding strength

    Time frame: 3 months-6 months

  3. Number of teeth that failed regarding the bonding strength

    Time frame: 6 months-9 months

  4. Number of teeth that failed regarding the bonding strength

    Time frame: 9 months-1 year

  5. Repeatability of bonding strength failure per patient and per tooth

    Time frame: baseline-3 months

  6. Repeatability of bonding strength failure per patient and per tooth

    Time frame: 3 months-6 months

  7. Repeatability of bonding strength failure per patient and per tooth

    Time frame: 6 months-9months

  8. Repeatability of bonding strength failure per patient and per tooth

    Time frame: 9months-1 year

  9. Breakage of fixed retainer wires

    Time frame: baseline-3 months

  10. Breakage of fixed retainer wires

    Time frame: 3 months-6 months

  11. Breakage of fixed retainer wires

    Time frame: 6 months-9 months

  12. Breakage of fixed retainer wires

    Time frame: 9 months-1 year

  13. Space discrepancy (Little index)(in mm)

    Time frame: baseline-3 months

  14. Space discrepancy (Little index)(in mm)

    Time frame: 3 months-6 months

  15. Space discrepancy (Little index)(in mm)

    Time frame: 6 months-9 months

  16. Space discrepancy (Little index)(in mm)

    Time frame: 9 months-1 year

  17. Mandibular intercanine distance

    Time frame: baseline-3 months

  18. Mandibular intercanine distance

    Time frame: 3 months-6 months

  19. Mandibular intercanine distance

    Time frame: 6 months-9 months

  20. Mandibular arch length (in mm)

    Time frame: 9 months-1 year

Secondary outcomes

  1. Tooth rotations in lower anterior teeth

    Time frame: baseline-3 months

  2. Tooth rotations in lower anterior teeth

    Time frame: 3 months-6 months

  3. Tooth rotations in lower anterior teeth

    Time frame: 6 months-9 months

  4. Tooth rotations in lower anterior teeth

    Time frame: 9 months-1 year

  5. Extrusion in lower anterior teeth

    Time frame: baseline-3 months

  6. Extrusion in lower anterior teeth

    Time frame: 3 months-6 months

  7. Extrusion in lower anterior teeth

    Time frame: 6 months-9 months

  8. Extrusion in lower anterior teeth

    Time frame: 9 months-1 year

  9. Tip inclinations anteroposteriorly

    Time frame: baseline-3 months

  10. Tip inclinations anteroposteriorly

    Time frame: 3 months-6 months

  11. Tip inclinations anteroposteriorly

    Time frame: 6 months-9 months

  12. Tip inclinations anteroposteriorly

    Time frame: 9 months -1 year

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Official study 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

Acronym: OrthRe10tion

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2023
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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