Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers.
NCT Number: NCT06529601
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Orthodontic Retainers
Interventions: DEVICE: CAD/CAM mandibular fixed retainer|DEVICE: Conventional mandibular fixed retainer
Sponsor: Azienda Ospedaliero-Universitaria Careggi
Sex: ALL
Age: CHILD, ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-09-01

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.

Primary Outcome Measures: 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., At 6 months and at 2 years
Secondary Outcome Measures: 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., 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., 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., 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., 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., At 6 months and at 2 years