NCT05915273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

3 years

First QC Date

June 13, 2023

Last Update Submit

June 13, 2023

Conditions

Relapse

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

CAD/CAM group

EXPERIMENTAL
Other: Computer Aided Design/ Computer Aided Manufacturing Retainers

Lab group

ACTIVE COMPARATOR
Other: Lab-based Retainers

Chairside group

ACTIVE COMPARATOR
Other: Chairside Retainers

Interventions

Computer Aided Design/ Computer Aided Manufacturing RetainersOTHER

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

Also known as: CAD/CAM
CAD/CAM group
Lab-based RetainersOTHER

The lab group used the same type of wire as the CAD/CAM group but was manually bent by a lab technician

Lab group
Chairside RetainersOTHER

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

Chairside group

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • refusal to participate
  • refusal to have fixed retainers
  • poor oral hygiene
  • non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63104, United States

Location

Related Publications (1)

  • Tran G, Rucker R, Foley P, Bankhead B, Adel SM, Kim KB. Relapse and failure rates between CAD/CAM and conventional fixed retainers: a 2-year follow-up of a randomized controlled clinical trial. Eur J Orthod. 2024 Jan 1;46(1):cjad079. doi: 10.1093/ejo/cjad079.

    PMID: 38168815DERIVED

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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.

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

  • Samar M Adel, PhD

    Alexandria University

    STUDY DIRECTOR

  • Ki B Kim

    Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer of Dental Public Health

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 22, 2023

Study Start

September 1, 2019

Primary Completion

September 1, 2022

Study Completion

September 30, 2022

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

US(1)