Comparative Evaluation of Xenograft Alone and Sticky Bone in Sinus Lift With Concurrent Implant Placement

Официальное название

Comparative Evaluation of Xenograft Alone and Sticky Bone in Sinus Lift With Concurrent Implant Placement: A Randomized Controlled Trial

Обзор

Introduction \& Background: Modern dental implantology offers solutions for patients with edentulism in the maxillary arch, where sinus pneumatization and alveolar ridge atrophy are common conditions. This often requires sinus floor elevation and bone grafting prior to implant placement. Techniques such as the lateral window approach and osteotome-mediated sinus floor elevation aim to achieve sufficient vertical bone height for successful implant placement. Autogenous bone grafts have long been considered the gold standard; however, their use is associated with limitations including donor site morbidity and graft volume loss, which has encouraged the exploration of alternative grafting materials. Sticky bone is a term used in oral surgery and implantology to describe a cohesive, moldable, and adhesive bone graft material prepared by combining particulate bone graft material (xenograft) with biological additives such as Platelet-Rich Plasma (PRP) or Platelet-Rich Fibrin (PRF). Platelet-Rich Fibrin (PRF), which is used in the present study, is an autologous leukocyte and platelet-rich fibrin matrix containing cytokines, platelets, and stem cells. PRF acts as a biodegradable scaffold that promotes microvascularization and guides epithelial cell migration. In addition, PRF may serve as a carrier for regenerative cells and allows sustained release of growth factors over a period ranging from one to four weeks, thereby enhancing the wound healing environment. Objectives: The study aims to assess the clinical efficacy of sticky bone as a bone graft material in sinus lift procedures compared with conventional xenograft materials. Methods: A randomized clinical trial will be conducted comparing two groups: one receiving sticky bone with simultaneous implant placement and another receiving xenograft with implant placement. Preoperative assessment will include Cone Beam Computed Tomography (CBCT) imaging, followed by postoperative monitoring to evaluate bone height and implant stability. Study Design: Patients fulfilling the inclusion and exclusion criteria will be recruited from the dental clinic. Written informed consent will be obtained from all participants after explanation of study procedures, potential risks, and expected benefits. Eligible patients will be randomly allocated into two equal groups using a computer-generated randomization program: Group 1 (Sticky Bone group) and Group 2 (Xenograft group). Statistical Analysis: Sample size calculation was performed using G\*Power software version 3.1.9.7. The statistical test family selected was the t-test. Based on data from a previous study, a total of 16 participants were required to achieve a study power of 80% with a significance level (alpha) of 0.05. To compensate for potential dropouts, the total sample size was increased to 18 participants (9 patients per group).

Вмешательства

• Процедура Sticky bone
  Sticky bone graft prepared using Platelet-Rich Fibrin (PRF) combined with xenograft material during sinus floor elevation.
• Процедура traditional xenograft
  Traditional xenografts as a bone graft material will be used during sinus floor elevation.

Первичные конечные точки

• Vertical Bone Height Gain [Срок оценки: Immediately postoperatively and 6 months after sinus floor elevation]

Вторичные конечные точки (1)

• Implant Insertion Torque [Срок оценки: At the time of implant placement (during surgery)]

Критерии участия

Критерии включения

• Adults aged 18 years and older.
• Patients presenting with residual bone height of less than 5 millimeters in the posterior maxilla requiring sinus floor elevation for dental implant placement.
• Good oral hygiene status with absence of active periodontal disease.
• Medically fit patients with no systemic conditions contraindicating oral surgical procedures.
• Non-smokers.
• Absence of acute or chronic maxillary sinusitis.

Критерии исключения

• Presence of uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus or severe cardiovascular diseases).
• Immunocompromised patients.
• History of radiation therapy to the head and neck region.
• History of sinus surgery or sinus pathology that may interfere with sinus floor elevation procedures.
• Presence of active infection or inflammation at the intended surgical site.
• Use of medications known to affect bone metabolism or healing, such as bisphosphonates or long-term corticosteroid therapy.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Lee EA. Subperiosteal Minimally Invasive Aesthetic Ridge Augmentation Technique (SMART): A New Standard for Bone Reconstruction of the Jaws. Int J Periodontics Restorative Dent. 2017 Mar/Apr;37(2):165-173. doi: 10.11607/prd.3171. PMID 28196155
• Abushama AA, Alim N, AlTuraiki AM, AlQahtani TT, Alotaibi NT, AlQahtani MM, AlQahtani NM. Comparison of xenograft and allograft bone graft for oral and maxillofacial surgical preparation prior to dental implantation: A systematic review. F1000Res. 2025 Jul 22;14:718. doi: 10.12688/f1000research.163924.1. eCollection 2025. PMID 40951319
• Khachatryan L, Khachatryan G, Hakobyan G, Khachatryan A. Simultaneous endoscopic endonasal sinus surgery and sinus augmentation with immediate implant placement: A retrospective clinical study of 23 patients. J Craniomaxillofac Surg. 2019 Aug;47(8):1233-1241. doi: 10.1016/j.jcms.2019.04.004. Epub 2019 Apr 19. PMID 31080051
• Stern A, Green J. Sinus lift procedures: an overview of current techniques. Dent Clin North Am. 2012 Jan;56(1):219-33, x. doi: 10.1016/j.cden.2011.09.003. PMID 22117952
• Sogo M, Ikebe K, Yang TC, Wada M, Maeda Y. Assessment of bone density in the posterior maxilla based on Hounsfield units to enhance the initial stability of implants. Clin Implant Dent Relat Res. 2012 May;14 Suppl 1:e183-7. doi: 10.1111/j.1708-8208.2011.00423.x. Epub 2011 Dec 16. PMID 22176704
• Silva LD, de Lima VN, Faverani LP, de Mendonca MR, Okamoto R, Pellizzer EP. Maxillary sinus lift surgery-with or without graft material? A systematic review. Int J Oral Maxillofac Surg. 2016 Dec;45(12):1570-1576. doi: 10.1016/j.ijom.2016.09.023. Epub 2016 Oct 17. PMID 27765427
• Starch-Jensen T, Aludden H, Hallman M, Dahlin C, Christensen AE, Mordenfeld A. A systematic review and meta-analysis of long-term studies (five or more years) assessing maxillary sinus floor augmentation. Int J Oral Maxillofac Surg. 2018 Jan;47(1):103-116. doi: 10.1016/j.ijom.2017.05.001. Epub 2017 May 22. PMID 28545806

Идентификаторы

NCT: NCT07444970 · Sticky bone with Implants

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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