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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Computer Aided Design/ Computer Aided Manufacturing Retainers

Lab-based Retainers

Chairside Retainers

About this trial

This is an interventional treatment trial for Relapse

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Saint Louis University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

CAD/CAM group

Lab group

Chairside group

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05915273

First Posted

June 13, 2023

Last Updated

June 13, 2023

Sponsor

Nourhan M.Aly

1. Study Identification

Unique Protocol Identification Number

NCT05915273

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

September 1, 2022 (Actual)

Study Completion Date

September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nourhan M.Aly

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapse

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CAD/CAM group

Arm Type

Experimental

Arm Title

Lab group

Arm Type

Active Comparator

Arm Title

Chairside group

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Computer Aided Design/ Computer Aided Manufacturing Retainers

Other Intervention Name(s)

CAD/CAM

Intervention Description

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

Intervention Name(s)

Lab-based Retainers

Intervention Description

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

Intervention Name(s)

Chairside Retainers

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in intercanine width (ICW)

Description

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.

Time Frame

2 years

Title

Change in Little's Irregularity Index (LII)

Description

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.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials: