Not Yet RecruitingNot Applicable

Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers.

54 participantsStarted 2024-09-01

Plain-language summary

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.

Who can participate

Age range

13 Years – 20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Retainer failure at 6-month and 2-year follow-ups

Timeframe: At 6 months and at 2 years

Trial details

NCT IDNCT06529601

SponsorAzienda Ospedaliero-Universitaria Careggi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-01

View on ClinicalTrials.gov More Orthodontic Retainers trials