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

Relapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05915273
• Other study ID #: 32524
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: June 2023
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 30, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Recurrence
• Relapse

Intervention

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

Locations

Country	Name	City	State
United States	Saint Louis University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Nourhan M.Aly

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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