SOI Immediately vs Delayed

Официальное название

The Efficacy of New SOI Implant Surface for Immediately Loaded, Post-extractive Versus Delayed Implants

Обзор

The aim of this randomized controlled trial is to compare the clinical and radiographic of immediately loaded, immediate (post-extractive, test group) versus delayed (control group) implants with new SOI surface

Вмешательства

• Устройство Immediately implant placement
  After atraumatic tooth extraction immediate implant placement with SOI surface and loading will be performed with temporary restoration. After osseointegration (8 weeks), the temporary restoration will be modified according to the soft tissue management. After 3 to 4 months, a definitive digital or analog impression will be taken and later definitive restoration will be delivered
• Устройство Delayed
  After atraumatic tooth extraction, the extraction site will be left to heal for 4 months, just grafting with A-Oss and suture, according to a socket preservation procedure. Four month later, implant will be place and immediate loadind with temporary restoration will be performed. After osseointegration (8 weeks), the temporary restoration will be modified according to the soft tissue management. After 3 to 4 months, a definitive digital or analog impression will be taken and later definitive re

Первичные конечные точки

• Number of prosthesis failure [Срок оценки: Up to 5 years]
• Number of implant failure [Срок оценки: Up to 5 years]
• Number of complications [Срок оценки: Up to 5 years]

Вторичные конечные точки (5)

• Rate of peri-implant marginal bone level changes [Срок оценки: At 1,3 and 5 years]
• Valuation of patient satisfaction [Срок оценки: At 1,3 and 5 years]
• Rate of implant stability quotient (ISQ) [Срок оценки: Up to 5 years]
• Valuation of soft tissue thickness and amount of keratinized tissue [Срок оценки: 1,3 and 5 years]
• Number of PES score [Срок оценки: 1,3 and 5 years]

Критерии участия

Критерии включения

• Any patient with at least one hopeless tooth in the mandible or maxilla, located between premolars, with intact post extractive alveolus. The implants must to engage at least 3 (mandible) to 5 (maxilla) mm of residual native bone over the socket.
• Patients with 18 years or older, and able to sign an informed consent.
• Smokers will be included and categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day). Heavy smokers will be excluded.
• Biotype will be categorized in thin (≤1 mm), medium (>1 - <2 mm) or thick (≥2 mm).

Критерии исключения

• General contraindications to implant surgery.
• Patients irradiated in the head and neck area.
• Immunosuppressed or immunocompromised patients.
• Patients treated or under treatment with intravenous amino-bisphosphonates.
• Patients with untreated periodontitis.
• Patients with poor oral hygiene and motivation.
• Uncontrolled diabetes.
• Heavy smokers.
• Pregnancy or nursing.
• Substance abuser.
• Psychiatric problems or unrealistic expectations.
• Lack of opposite occluding dentition in the area intended for implant placement.
• Patients with infection and or inflammation in the area intended for implant placement.
• Patients participating in other studies, if the present protocol cannot be properly adhered to.
• Patients referred only for implant placement and cannot be followed ant the treating centre.
• Patients unable to be followed for 5 years

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Marco Tallarico — Sassari

Идентификаторы

NCT: NCT06286579 · UNISS_PHD_Osstem_3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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