Ridge Augmentation Using Allograft Particles Hydrated With or Without Recombinant Human Platelet-Derived Growth Factor

Официальное название

Lateral Ridge Augmentation Using Allograft Bone Particles Hydrated With or Without Recombinant Human Platelet-Derived Growth Factor: A Clinical and Histological Randomized Controlled Trial

Обзор

This study will compare two techniques to achieve increase in ridge dimensions as a preparation for dental implants using a resorbable barrier membrane and bone particulate allogenic graft hydrated with saline or a growth factor called Recombinant Human Platelet-Derived Growth Factor (rhPDGF).

Подробное описание

This is a prospective, randomized, and examiner-only-masked study. It is designed to clinically compare the use of bone particulate allograft hydrated with rhPDGF vs bone particulate allograft hydrated with saline, for patients who were planned to receive dental implants but presented with deficient bone ridges. This investigation of two techniques to achieve increase in ridge dimensions as a preparation for dental implants using a resorbable barrier membrane and bone particulate allogenic graft hydrated with saline or a growth factor called Recombinant Human Platelet-Derived Growth Factor (rhPDGF).

In two arms, bone core biopsies will be harvested at time of implant placement 4 months following ridge augmentation grafting. These 2x8mm bone cores will then undergo histological and histomorphometrical analyses to determine qualitative and quantitative healing differences between in both study arms.

Clinical measurements are gathered at 2 time points (grating and implant placement) at all defects and will be compared for differences.

Cone beam computed tomography (CBCT) initial scans are conducted immediately following prior to ridge augmentation and second scans obtained prior to implant placement both arms. These types of Cone Beam CT scans as well as conventional dental x-rays are valuable treatment planning tools that are commonly used in modern-day implant dentistry. The scans and the x-ray images are also used to monitor the health of tissues surrounding implants and to make sure that the implant remains securely implanted into the jawbone over time.

Вмешательства

• Биопрепарат Allograft particles hydrated with rhPDGF
  Allograft particles should be hydrated with GEM21S for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane.
• Биопрепарат Allograft particles hydrated in a conventional way with saline.
  Allograft particles should be hydrated with saline for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane

Первичные конечные точки

• Quantitative histomorphometric evaluation of new bone formation 4 months after GBR [Срок оценки: From baseline to 4 months]

Вторичные конечные точки (1)

• Quantitative two- and three-dimensional radiographic comparison of dimensional changes 4 months using cone beam computed tomography (CBCT) and a virtual implant planning software, coDiagnostiX™ [Срок оценки: From baseline to 4 months]

Критерии участия

Критерии включения

• English speaking
• At least 18 years old
• Must be a patient of the UAB Dental School
• Able to read and understand informed consent document
• Need for implants to replace missing tooth or teeth in at least one quadrant of the mouth.
• Insufficient alveolar ridge width for endosseous implant placement defined as 5mm or less as determined by bone sounding and cone beam computed tomography (CBCT) scan.

Критерии исключения

• Non-English speaking
• Less than 18 years old
• Smokers/tobacco users (>10 cigarettes/day)
• Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
• Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse)
• Vertical loss of bone at edentulous ridge.

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

США · 1 центр

• Unversity of Alabama at Birmingham, School of Dentistry — Birmingham

Идентификаторы

NCT: NCT04954664 · IRB-300007719 · UAB Periodontology

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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