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

Relapse and Failure Rates Between CAD/CAM and Conventional Fixed Retainers: A 2-year Follow-up of a Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Relapse
• Intervention / Treatment: Other: Computer Aided Design/ Computer Aided Manufacturing Retainers; Other: Lab-based Retainers; Other: Chairside Retainers

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in intercanine width (ICW)	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 years
Change in Little's Irregularity Index (LII)	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.	2 years

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 32524

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No