An interventional study of CAD/CAM mandibular fixed retainer and Conventional mandibular fixed retainer in Orthodontic Retainers, sponsored by Azienda Ospedaliero-Universitaria Careggi. Recruiting at 1 site in Italy. Open to participants aged 13 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Azienda Ospedaliero-Universitaria Careggi · Not applicable, Interventional, and Treatment
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.
Azienda Ospedaliero-Universitaria Careggi is the lead sponsor of 77 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: CAD/CAM mandibular fixed retainer
Device: Conventional 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).
Also known as: Keeppy
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.
Retainer failure at 6-month and 2-year follow-ups
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.
Time frame: At 6 months and at 2 years
Assessment of the plaque and gingival bleeding index at the central and lateral incisors and lower canines.
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
Pain measured through Visual Analogue Scale (VAS) with minimum value of 0 and maximum value of 10. Higher scores mean worse pain.
Time frame: At baseline, at one month, at 6 months and at 2 years
Difficulty in speaking reported by patients
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.
Time frame: At baseline, at one month, at 6 months and at 2 years
Aesthetic satisfaction reported by patients
Aesthetic satisfaction measured through Visual Analogue Scale (VAS) with minimum value of 0 and maximum value of 10. Higher scores mean higher aesthetic satisfaction.
Time frame: At baseline, at one month, at 6 months and at 2 years
Stability of the alignment of the lower anterior teeth
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.
Time frame: At 6 months and at 2 years
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Azienda Ospedaliero-Universitaria Careggi