Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers.
- Conditions
- Orthodontic Retainers
- Interventions
- Device: CAD/CAM mandibular fixed retainerDevice: Conventional mandibular fixed retainer
- Registration Number
- NCT06529601
- Lead Sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 54
- Patients who have completed fixed orthodontic therapy between the ages of 13 and 20 years;
- Patients whose parents will sign the informed consent
- Presence of dental anomalies in number (excess or deficiency) in the lower anterior teeth
- Patients with metal allergies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CAD/CAM mandibular fixed retainer CAD/CAM mandibular fixed retainer - Conventional mandibular fixed retainer Conventional mandibular fixed retainer -
- Primary Outcome Measures
Name Time Method Retainer failure at 6-month and 2-year follow-ups At 6 months and at 2 years 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.
- Secondary Outcome Measures
Name Time Method Stability of the alignment of the lower anterior teeth At 6 months and at 2 years 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.
Pain reported by patients At baseline, at one month, at 6 months and at 2 years Pain measured through Visual Analogue Scale (VAS) with minimum value of 0 and maximum value of 10. Higher scores mean worse pain.
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 Assessment of the plaque and gingival bleeding index at the central and lateral incisors and lower canines.
Difficulty in speaking reported by patients At baseline, at one month, at 6 months and at 2 years 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.
Aesthetic satisfaction reported by patients At baseline, at one month, at 6 months and at 2 years Aesthetic satisfaction measured through Visual Analogue Scale (VAS) with minimum value of 0 and maximum value of 10. Higher scores mean higher aesthetic satisfaction.