RCT GBR One Stages Comparing A-Oss and Autogenous Bone Versus A-Oss and LCR-A

Официальное название

Horizontal Ridge Augmentation Using One-stage Guided Bone Regeneration (GBR) for Bone Defect Class IV of Cawed and Howell With Collagene Membrane (OssMem) and a Mix of Bovine Bone Substitute (A-Oss) and Autogenous Bone Versus A-Oss and LCR-A, a Synthetic Bone : a Randomized Controlled Trial

Обзор

The aim of this randomized controlled trial is to evaluate the tridimensional bone stability after horizontal one-stage GBR using collagene membrane (OssMem) with a mix of Bovine Bone Substitute (A-Oss) and autogenous bone (test group) versus A-Oss and LCR-A, a synthetic bone (control group).

Вмешательства

• Процедура A-oss and autogenous bone
  Horizontal ridge augmentation in one stages approach will be performed using a mix of A-Oss and autologenous bone.
• Процедура A-oss an LCR-A
  Horizontal ridge augmentation in one stages approach will be performed using OssMem with A-Oss and LCR-A

Первичные конечные точки

• Rate of Implants survival [Срок оценки: Up to 5 years]
• Number of Participants with prosthesis failure [Срок оценки: Up to 5 years]
• Number of complications [Срок оценки: Up to 5 years]

Вторичные конечные точки (6)

• Horizontal and volumetric dimensional changes [Срок оценки: 6 and 12 months]
• Rate of peri-implant marginal bone level [Срок оценки: At 1,3 and 5 years]
• Plaque Index and bleeping on probing [Срок оценки: At 1,3 and 5 years]
• Valuation of patient satisfaction [Срок оценки: At 1,3 and 5 years]
• Valuation of soft tissue thickness and amount of keratinized tissue [Срок оценки: At 1,3 and 5 years]
• Rate of pes score [Срок оценки: At 1,3 and 5 years]

Критерии участия

Критерии включения

• Patients that required an implant supported restoration and staged horizontal guided bone regeneration (defect of class IV according to Cawed and Howell) in both mandible or maxilla.
• Patents able to understand and sign an informed consent.
• Patients were to be 18 years or older with a residual horizontal ridge thickness of 4 mm or less (Cawood-Howell Class III- IV) in the intended implant site.
• Smokers will be categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day). Only categories 1 and 2 will be included.

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.
• Pregnancy or nursing.
• Substance abuser.
• Heavy smokers (smoking more than 11 cigarettes/day).
• Psychiatric problems or unrealistic expectations.
• Lack of opposite occluding dentition in the area intended for implant placement.
• Immediate implants (extractive sites will have to be healed from 6-8 weeks).
• 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

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Marco Tallarico — Sassari

Идентификаторы

NCT: NCT06286605 · UNISS_PHD_Osstem_4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗