Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers.

Официальное название

Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers: a Randomized Controlled Trial

Обзор

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.

Вмешательства

• Устройство CAD/CAM 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
• Устройство Conventional mandibular fixed retainer
  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 lengt

Первичные конечные точки

• Retainer failure at 6-month and 2-year follow-ups [Срок оценки: At 6 months and at 2 years]

Вторичные конечные точки (5)

• Assessment of the plaque and gingival bleeding index at the central and lateral incisors and lower canines. [Срок оценки: At baseline, at 6 months and at 2 years]
• Pain reported by patients [Срок оценки: At baseline, at one month, at 6 months and at 2 years]
• Difficulty in speaking reported by patients [Срок оценки: At baseline, at one month, at 6 months and at 2 years]
• Aesthetic satisfaction reported by patients [Срок оценки: At baseline, at one month, at 6 months and at 2 years]
• Stability of the alignment of the lower anterior teeth [Срок оценки: At 6 months and at 2 years]

Критерии участия

Критерии включения

• Patients who have completed fixed orthodontic therapy between the ages of 13 and 20 years;
• Patients whose parents will sign the informed consent

Критерии исключения

• Presence of dental anomalies in number (excess or deficiency) in the lower anterior teeth
• Patients with metal allergies.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Orthodontic Clinic, Division of Dentistry, Careggi University Hospital — Florence

Идентификаторы

NCT: NCT06529601 · LF15

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗