Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers.

July 29, 2024 updated by: Azienda Ospedaliero-Universitaria Careggi

Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers: a Randomized Controlled Trial

The devices compared in this study are 'retainers', i.e. fixed orthodontic retainers applied to the lingual surface of the central and lateral incisors and lower canines bilaterally. Their function is to maintain dental alignment once fixed orthodontic therapy has ended. In particular, the CAD/CAM device Keeppy patented by the company Leone SpA (Via Ponte a Quaracchi 50, Sesto Fiorentino, Florence) will be compared with the standard retainer made from a steel braided wire (Ortho FlexTech, Reliance Orthodontic Products Inc., 1540 West Thorndale Ave, Itasca, Illinois, USA).

This is a single-center, national, controlled, superiority, randomized, crossover, open-label study.

The aim of this study is to evaluate whether the CAD/CAM retainer results in fewer failures (fractures or detachments) over a period of 6 months and 2 years compared to the standard retainer. In addition, the aim of the study is to evaluate whether the Keeppy device results in the maintenance of better periodontal health as judged by the use of plaque and bleeding indices on the surfaces of the lower six anterior teeth compared to the standard retainer. Other objectives consist of the patient's assessment of pain, difficulty in speaking and esthetic satisfaction and the stability of the lower anterior tooth sector.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who have completed fixed orthodontic therapy between the ages of 13 and 20 years;
  • Patients whose parents will sign the informed consent

Exclusion Criteria:

  • Presence of dental anomalies in number (excess or deficiency) in the lower anterior teeth
  • Patients with metal allergies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CAD/CAM mandibular fixed retainer
Device: CAD/CAM mandibular fixed retainer
Keeppy is a Class IIa custom-made medical device manufactured by Digital Service Leone s.r.l. - via Pratese 160/b, Florence, Italy. The Keeppy is an individualized fixed retainer, made of a Nickel-free Chrome Cobalt alloy, produced with a CAD-CAM procedure starting from a digital impression made with an intraoral optical scanner (3 Shape), which allows a perfect adaptation to the lingual surfaces of the 6 lower anterior teeth on which it is bonded. The device is characterized by the presence of applicators that can be placed temporarily on the buccal surface of the canines, which facilitate the clinician in the precise application of the device and which are removed as soon as the bonding phase of the retainer is complete. Bonding is performed using classic composite resins following a preparation phase of the lingual surface of the tooth consisting of the application of etchant (37% orthophosphoric acid) for 30 seconds and adhesive (primer-bonding).
Other Names:
  • Keeppy
Active Comparator: Conventional mandibular fixed retainer
Device: Conventional mandibular fixed retainer
The standard control device, which is among the most commonly used in routine clinical practice, consists of a steel braided wire. The device selected for the Class IIa investigation is the Ortho Flex Tech manufactured by Reliance Orthodontic Products, Inc. 1540 West Thorndale Ave. Itasca, IL 60143 USA. The Ortho Flex Tech steel braided wire is manually shaped by the clinician and cut with a wire cutter so that it has the proper length to extend over the 6 dental elements. Once the correct length has been defined, it is then held in place on the lingual surface of the teeth by the use of 2 interdental wires passing doubly through the interdental area (between the lateral incisor and canine on one side and the other). This allows the device to be bonded using composite resin after etching the lingual surfaces of the lower anterior teeth.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Retainer failure at 6-month and 2-year follow-ups
Time Frame: At 6 months and at 2 years
The primary endpoint is retainer failures at 6-month and 2-year follow-ups. Failure is defined as any complication requiring a retainer repair, in particular total or partial detachment and total or partial fracture.
At 6 months and at 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of the plaque and gingival bleeding index at the central and lateral incisors and lower canines.
Time Frame: At baseline, at 6 months and at 2 years
Assessment of the plaque and gingival bleeding index at the central and lateral incisors and lower canines.
At baseline, at 6 months and at 2 years
Pain reported by patients
Time Frame: At baseline, at one month, at 6 months and at 2 years
Pain measured through Visual Analogue Scale (VAS) with minimum value of 0 and maximum value of 10. Higher scores mean worse pain.
At baseline, at one month, at 6 months and at 2 years
Difficulty in speaking reported by patients
Time Frame: At baseline, at one month, at 6 months and at 2 years
Difficulty in speaking measured through Visual Analogue Scale (VAS) with minimum value of 0 and maximum value of 10. Higher scores mean worse difficulty in speaking.
At baseline, at one month, at 6 months and at 2 years
Aesthetic satisfaction reported by patients
Time Frame: At baseline, at one month, at 6 months and at 2 years
Aesthetic satisfaction measured through Visual Analogue Scale (VAS) with minimum value of 0 and maximum value of 10. Higher scores mean higher aesthetic satisfaction.
At baseline, at one month, at 6 months and at 2 years
Stability of the alignment of the lower anterior teeth
Time Frame: At 6 months and at 2 years
Stability of the alignment of the lower anterior teeth will be assessed with Little's irregularity index and the intercanine diameter measured on the virtual impression of the patient's teeth.
At 6 months and at 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Ospedaliero-Universitaria Careggi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LF15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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