Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes

Официальное название

Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes: A Randomized Controlled Clinical Trial

Обзор

The aim of this clinical trial is to compare the horizontal bone gain when grafting a bone substitute with non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) in resorbed ridges requiring Guided Bone Regeneration (GBR) to facilitate implant placement at 6 months.

Подробное описание

The aim of this clinical trial is to compare the horizontal bone gain when grafting a mixture of xenograft and allograft (50/50) with non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) in resorbed ridges requiring Guided Bone Regeneration (GBR) to facilitate implant placement at 6 months.

Вмешательства

• Процедура Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane
  Horizontal Guided Bone Regeneration, with a mixture of xenograft (Cerabone®) and allograft (Maxgraft®), on a 50-50 mixture ratio, grafted in the area required to be augmented, and then covered by a collagen membrane (Jason® membrane), being fixed with non-resorbable pins (Test Group).
• Процедура Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane
  Horizontal Guided Bone Regeneration, with a mixture of xenograft (Cerabone®) and allograft (Maxgraft®), on a 50-50 mixture ratio, grafted in the area required to be augmented, and then covered by a collagen membrane (Jason® membrane), being left unfixed (Control Group).

Первичные конечные точки

• Horizontal Bone Gain [Срок оценки: T3: 6 months after the Horizontal GBR]
• Bone Width Gain [Срок оценки: T3: 6 months after the Horizontal GBR]

Вторичные конечные точки (4)

• Horizontal Dimensional Stability [Срок оценки: T3: 6 months after the Horizontal GBR]
• Post-surgical complications [Срок оценки: T2-T3: From the surgery to 6 months]
• Patient's satisfaction [Срок оценки: At 2-weeks follow up after the surgical procedure]
• Histologic examination of the augmented bone at 6 months [Срок оценки: At time of implant placement]

Критерии участия

Критерии включения

• Men and women over 18 years old or older
• Patients requiring Guided Bone Regeneration due to insufficient ridge width(≤5mm) to place dental implants, with sufficient vertical ridge height (≥9mm) from vital anatomical structures (the inferior alveolar nerve in the Mandible, or the sinus in the Maxilla)
• One or more teeth missing in posterior zone (Premolars, and Molars)
• Absence of active Periodontal disease
• Good level of oral hygiene (Plaque index <25%)
• Absence of systemic diseases that could influence the outcome of the therapy (Uncontrolled diabetes, osteoporosis, bisphosphonate medications)
• Non smokers or light smokers (<10 cigarettes per day)
• Informed consent signed

Критерии исключения

• Patients with sufficient ridge width (>5 mm) and height (≥9mm) from vital anatomical structure) requiring no GBR to place dental implants
• Patients with severe horizontal and vertical defects requiring other surgical techniques.
• Long-term non-steroidal anti-inflammatory drug therapy (3months).
• Lactating females or currently pregnant women.
• Severe cognitive or psychiatric disorders.
• Unwillingness to return for follow-up examination.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Georgios Markantonatos — Barcelona

Публикации

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• Amano Y, Ota M, Sekiguchi K, Shibukawa Y, Yamada S. Evaluation of a poly-l-lactic acid membrane and membrane fixing pin for guided tissue regeneration on bone defects in dogs. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Feb;97(2):155-63. doi: 10.1016/j.tripleo.2003.09.009. PMID 14970774
• Francis J. Hughes. Stem Cell Biology and Tissue Engineering in Dental Sciences, Academic Press,2015, ISBN 9780123971579: 434-444

Идентификаторы

NCT: NCT06334159 · PER-ECL-2019-08

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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