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Recruiting NCT06529601

Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers.

No phase Interventional Orthodontic Retainers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CAD/CAM mandibular fixed retainer, Conventional mandibular fixed retainer.
Who it may be relevant to
Registry conditions: Orthodontic Retainers. Basic parameters: 13 years — 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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
  • 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 lengt

Primary outcome measures

  • Retainer failure at 6-month and 2-year follow-ups [Time frame: At 6 months and at 2 years]
Secondary outcome measures (5)
  • 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]
  • Pain reported by patients [Time frame: 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]
  • Aesthetic satisfaction reported by patients [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Orthodontic Clinic, Division of Dentistry, Careggi University Hospital — Florence

Identifiers

NCT: NCT06529601 · LF15

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗