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The Effectiveness of 3 Orthodontic Fixed Retention Schemes on Post-treatment Stability and Gingival Recession (OrthRe10tion)

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ClinicalTrials.gov Identifier: NCT05926934
Recruitment Status : Recruiting
First Posted : July 3, 2023
Last Update Posted : July 3, 2023
Sponsor:
Information provided by (Responsible Party):
Iosif Sifakakis, University of Athens

Study Description
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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.


Condition or disease Intervention/treatment Phase
Relapse Orthodontic Retention Device: Experimental: Single strand β-Ti fixed retainer Device: Experimental: SS fixed retainer Device: Experimental: Twisted fixed retainer Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 16, 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : November 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Single strand β-Ti fixed retainer
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
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
SS fixed retainer 0.028in diameter, bonded on each tooth separately from #33-43
 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.
Experimental: Twisted fixed retainer
Twisted fixed retainer 0.027in diameter, bonded on each tooth separately from #33-43
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   13 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05926934


Contacts
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Contact: Iosif Sifakakis, Associate Professor 210 74612278 isifak@dent.uoa.gr
Contact: Panagiotis Roulias, Researcher rouliaspanagiotis@gmail.com

Locations
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Greece
National and Kapodistrian University of Athens, School of Dentistry, Departments of Orthodontics Recruiting
Athens, Attiki, Greece, 11527
Contact: Iosif Sifakakis, Ass. Prof.    00302107461228    isifak@dent.uoa.gr   
Sponsors and Collaborators
University of Athens
More Information
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Responsible Party: Iosif Sifakakis, Associate Professor, University of Athens
ClinicalTrials.gov Identifier: NCT05926934    
Other Study ID Numbers: 409/08.02.2022
First Posted: July 3, 2023    Key Record Dates
Last Update Posted: July 3, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes