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Relapse and Failure Rates Between CAD/CAM and Conventional Fixed Retainers

Sponsor
Nourhan M.Aly (Other)
Overall Status
Completed
CT.gov ID
NCT05915273
Collaborator
(none)
43
Enrollment
1
Location
3
Arms
37
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study was to compare the differences in relapse and failure rates in patients treated with fixed retainers (FRs) using Computer-Aided Design/Computer-Aided Manufacturing technology, lab-based technique, and chairside method.

Condition or Disease Intervention/Treatment Phase
  • Other: Computer Aided Design/ Computer Aided Manufacturing Retainers
  • Other: Lab-based Retainers
  • Other: Chairside Retainers
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Relapse and Failure Rates Between CAD/CAM and Conventional Fixed Retainers: A 2-year Follow-up of a Randomized Controlled Clinical Trial
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Sep 1, 2022
Actual Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: CAD/CAM group

Other: Computer Aided Design/ Computer Aided Manufacturing Retainers
Custom-bent fixed retainer wires from an in-office CAD/CAM system with FixR software and the BenderI machine (YOAT Corporation, Lynwood, WA). Dentaflex wires- round, 0.5mm in diameter, three-stranded Stainless Steel (Dentaurum GmbH & Co., Ispringen, Germany)- were used for the CAD/CAM group
Other Names:
  • CAD/CAM

    		•
    Active Comparator: Lab group

    Other: Lab-based Retainers
    The lab group used the same type of wire as the CAD/CAM group but was manually bent by a lab technician
    Active Comparator: Chairside group

    Other: Chairside Retainers
    The chairside group used three-stranded Stainless Steel, 0.974mm x 0.402 mm, flexible Ortho-FlexTech wires (Reliance, Itasca, IL)

    Outcome Measures

    Primary Outcome Measures

    1. Change in intercanine width (ICW) [2 years]

      ICW was measured on the Meshlab software using the 3D ruler measurement tool. Pre-treatment, post-treatment, and post-retention measures were recorded and any change in the ICW was considered relapse.

    2. Change in Little's Irregularity Index (LII) [2 years]

      ICW was measured on the Meshlab software using the 3D ruler measurement tool. Pre-treatment, post-treatment, and post-retention measures were recorded and any change in the LII was considered relapse.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • completion of comprehensive orthodontic treatment

    • class I molar and canine relationships

    • indication for a fixed retainer on the mandibular anterior teeth.

    • no extractions done as part of their treatment.

    • Treatment with preadjusted edgewise appliance.

    Exclusion Criteria:

    • refusal to participate

    • refusal to have fixed retainers

    • poor oral hygiene

    • non-compliance

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saint Louis University Saint Louis Missouri United States 63104

    Sponsors and Collaborators

    • Nourhan M.Aly

    Investigators

    • Principal Investigator: Giau Tran, Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.
    • Principal Investigator: Ryan Rucker, Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.
    • Study Chair: Patrick Foley, PhD, Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.
    • Study Chair: Brent Bankhead, Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.
    • Study Director: Samar M Adel, PhD, Alexandria University
    • Study Director: Ki B Kim, Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nourhan M.Aly, Assistant Lecturer of Dental Public Health, University of Alexandria
    ClinicalTrials.gov Identifier:
    NCT05915273
    Other Study ID Numbers:
    • 32524
    First Posted:
    Jun 22, 2023
    Last Update Posted:
    Jun 22, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Recurrence

    Study Results

    No Results Posted as of Jun 22, 2023