Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery

Официальное название

Prospective, Randomized, Controlled, Multicenter Study on the Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery

Обзор

Guided Bone Regeneration (GBR) is a well-established surgical technique that employs barrier membranes to ensure the stability of bone augmentation material while preventing the infiltration of soft tissue, thereby facilitating new bone formation. The primary objective of this randomized controlled trial is to assess the performance and safety of the Lyoplant® collagen membrane as a barrier membrane in GBR for patients undergoing dental implant surgery. Additionally, the study aims to compare the Lyoplant® membrane with the Bio-Gide® collagen membrane, with the goal of demonstrating the non-inferiority of the Lyoplant® membrane in terms of radiographically measured bone gain compared to the comparator.

Вмешательства

• Процедура GBR Lyoplant
  GBR surgical procedure with simultaneous implant placement including membrane placement
• Процедура GBR Bio-Gide
  GBR surgical procedure with simultaneous implant placement including membrane placement

Первичные конечные точки

• Gain of horizontal bone thickness at the augmented site [Срок оценки: At Visit 5: 5 months after GBR intervention]

Вторичные конечные точки (3)

• Number of side effects [Срок оценки: At each follow-up visit: V3 (after 7-14 days), V4 (after 1 month ± 7 days) and V5 (after 5 months ± 2 weeks)]
• Number of safety endpoints [Срок оценки: At each follow-up visit: V3 (after 7-14 days), V4 (after 1 month ± 7 days) and V5 (after 5 months ± 2 weeks)]
• Membrane usability [Срок оценки: At V2 (surgery): directly after GBR intervention]

Критерии участия

Критерии включения

• Patients who are willing to give a voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the Informed Consent Form (ICF).
• Patients with the capacity to consent for themselves.
• Patients in need of an implant with a simultaneous GBR procedure.
• Presence of buccal bony dehiscence with a vertical defect height (VDH) ≥ 1 mm and ≤ 6 mm after implant placing.
• The tooth at the implant site must have been extracted or lost at least 8 weeks before the date of bone augmentation (volumetrically healed site).

Критерии исключения

• Patients < 18 years.
• Currently pregnant or breastfeeding women.
• Major systemic diseases (e.g. recent myocardial infarction, cerebrovascular accident or valvular prosthesis surgery, a poorly stabilized diabetes mellitus, severe hypertension, severe peripheral artery occlusive disease, malignancies, autoimmune diseases, or kidney diseases, untreated or uncontrolled periodontal disease, uncontrolled drug or alcohol abuse, uncontrolled psychiatric disorders).
• Acute infectious diseases.
• Immunocompromised patients.
• Serious disturbances of bone metabolism and/or serious bone diseases of endocrine etiology.
• Medical conditions requiring prolonged use (> 6 months) of steroids and/or ongoing treatment with gluco- and mineralocorticoids and with agents affecting calcium metabolism (e.g. calcitonin), and/or anticoagulative therapy.
• Previous or current use of antiresorptive drugs (ARDs) (e.g. bisphosphonates, selective estrogen receptor modulators (SERMs), denosumab, hormone replacement therapy and calcitonin).
• Previous oral / maxillofacial radiotherapy.
• Heavy smoker (>10 cigarettes/day). In the case of vapors with nicotine, the use of >300 puff vapors (equivalent to 10 cigarettes/day) are not allowed.
• Health conditions, which do not permit the surgical treatment.
• Use of the Investigational Device / Comparator in infected areas.
• Known foreign body sensitivity to implant materials.
• Simultaneous participation in another interventional clinical trial (drugs or medical devices studies) if it could impact the result of the study.

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

Испания · 2 центра

• Hospital Odontològic Universitat de Barcelona, Campus Ciències de la Salut de Bellvitge — Barcelona
• Clínica Universitaria d.Odontologia de la Universitat Internacional de Catalunya — Sant Cugat Del Vallés

Идентификаторы

NCT: NCT06732167 · AAG-G-H-2014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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