Keeppy CAD/CAM mandibular retainer vs standard steel wire retainer after braces
Official title: Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers: a Randomized Controlled Trial
Run by Azienda Ospedaliero-Universitaria Careggi · NCT06529601 · Data updated 2026-11-12
A 6-month to 2-year test to see if the Keeppy CAD/CAM mandibular retainer reduces breakages and keeps teeth aligned better than a traditional steel wire retainer in teens and young adults who have finished braces.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 13 Years to 20 Years |
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | Azienda Ospedaliero-Universitaria Careggi Academic / other |
| Locations | 1 site (Florence) |
| Status | Recruiting |
| Started | February 12, 2025 |
| Main results expected | February 1, 2027 |
| Study ends | August 1, 2028 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT06529601 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are 13–20-year-olds who recently finished fixed orthodontic treatment and whose guardians provide informed consent.
✕Probably not a fit
Patients with dental anomalies in the lower anterior teeth or metal allergies may not benefit from this retainer comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, national, randomized, crossover study comparing a CAD/CAM mandibular fixed retainer (Keeppy) with a conventional steel braided wire retainer. Participants who completed fixed orthodontic therapy and are 13–20 years old will receive both retainers in a crossover design over set intervals, with open-label administration. The primary goal is to determine if Keeppy experiences fewer failures (fractures or detachments) over 6 months and 2 years compared with the standard retainer, while also observing periodontal health outcomes. The trial is supervised by Azienda Ospedaliero-Universitaria Careggi in Florence, Italy, and has no listed collaborators. Outcomes will inform whether CAD/CAM retainers offer a tangible maintenance advantage after orthodontic treatment.
Why it matters
Potential benefit: If successful, Keeppy retainers could reduce maintenance issues and improve long-term dental stability after braces.
How similar studies have gone: Previous studies on CAD/CAM dental appliances have shown promise, but results vary by device and outcome; this study adds randomized, crossover data for a specific CAD/CAM retainer.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Orthodontic Clinic, Division of Dentistry, Careggi University Hospital
Florence, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.