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

NCT ID: NCT05915273

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Relapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CAD/CAM group

Group Type EXPERIMENTAL

Computer Aided Design/ Computer Aided Manufacturing Retainers

Intervention Type OTHER

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 group

Group Type ACTIVE_COMPARATOR

Lab-based Retainers

Intervention Type OTHER

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

Chairside group

Group Type ACTIVE_COMPARATOR

Chairside Retainers

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Chairside Retainers

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

Intervention Type OTHER

Other Intervention Names

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CAD/CAM

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nourhan M.Aly

OTHER

Sponsor Role lead

Responsible Party

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Nourhan M.Aly

Assistant Lecturer of Dental Public Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Giau Tran

Role: PRINCIPAL_INVESTIGATOR

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

Ryan Rucker

Role: PRINCIPAL_INVESTIGATOR

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

Patrick Foley, PhD

Role: STUDY_CHAIR

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

Brent Bankhead

Role: STUDY_CHAIR

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

Samar M Adel, PhD

Role: STUDY_DIRECTOR

Alexandria University

Ki B Kim

Role: STUDY_DIRECTOR

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

Locations

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Saint Louis University

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38168815 (View on PubMed)

Other Identifiers

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32524

Identifier Type: -

Identifier Source: org_study_id

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