The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation

Обзор

Pneumatization of the maxillary sinus may lead to insufficient bone volume for dental implant placement in the edentulous posterior maxilla. Sinus floor elevation (SFE) surgery with the lateral window technique is a safe and predictable surgical intervention to restore bone height in the maxillary premolar and molar areas. According to the literature, several bone graft materials may be successfully applied for SFE surgery. There is a lack of evidence regarding the application of biphasic calcium sulfate (BCS) for SFE. The healing period following staged SFE is 2-9 months. The aim of this study is: * to evaluate the success of SFE surgery using BCS as graft material, * to compare the microarchitecture of the augmented bone depending on the healing period, * to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.

Вмешательства

• Процедура Sinus floor elevation (SFE)
  Patients rinse with 0.2% chlorhexidine solution for one minute before surgery. Under local anesthesia, a mucoperiosteal flap is raised from a midcrestal incision and two relieving incisions. Lateral window osteotomies are carried out using diamond burs. The Schneiderian membrane is carefully elevated and the synthetic bone graft material (Bond Apatite, Augma Biomaterials, Cesarea, Israel) (2-3 cm3) is packed in the defect with light force. The buccal flap is then mobilized to allow tension-free
• Диагностический тест preoperative cone beam computed tomography (CBCT)
  A CBCT scan is performed before SFE surgery to evaluate the anatomy and pathologies of the maxillary sinus.
• Диагностический тест postoperative CBCT
  A CBCT scan is performed following the 3- or 6-month-long healing period after SFE to evaluate the anatomy and healing of the augmented bone and the maxillary sinus.
• Диагностический тест bone core biopsy
  At the time of dental implant placement, the first step of the implant bed preparation is performed using a trephine drill to harvest a bone core biopsy sample from the augmented bone. The biopsy sample is harvested from the implant bed, this way the patient is spared of excess surgical burden as this bone would be removed even if no biopsy sample was harvested during dental implant placement. The bone core biopsy samples are subjected to histomorphometric and microCT analysis.
• Процедура dental implant placement
  Following the 3- or 6-month-long healing period following SFE, dental implants are placed non-submerged in the augmented bone under local anesthesia.
• Процедура fixed dental prosthesis (FDP) fabrication
  3 months after dental implant placement, fixed dental prostheses are delivered on the dental implants.
• Устройство bone grafting
  A synthetic bone graft material (Bond Apatite, Augma Biomaterials, Cesarea, Israel) is used during SFE.

Первичные конечные точки

• Success of the SFE [Срок оценки: 3 or 6 months]
• Success of the dental implants [Срок оценки: 5 years]
• Success of the implant borne prostheses [Срок оценки: 5 years]

Вторичные конечные точки (11)

• Hisomorphometry: Percent of residual bone graft particles [Срок оценки: 3-6 months]
• Hisomorphometry: Percent of newly formed bone [Срок оценки: 3-6 months]
• Hisomorphometry: Percent of bone marrow [Срок оценки: 3-6 months]
• Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples. [Срок оценки: 3-6 months]
• Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples. [Срок оценки: 3-6 months]
• Value of the trabecular thickness (Tb.Th.), calculated from the microCT reconstructions of the bone core biopsy samples. [Срок оценки: 3-6 months]
• Value of the trabecular separation (Tb.Sp.), calculated from the microCT reconstructions of the bone core biopsy samples. [Срок оценки: 3-6 months]
• Value of the trabecular bone pattern factor (Tb.Pf), calculated from the microCT reconstructions of the bone core biopsy samples. [Срок оценки: 3-6 months]
• Value of the structure model index (SMI), calculated from the microCT reconstructions of the bone core biopsy samples. [Срок оценки: 3-6 months]
• Value of the Total porosity (Po(tot)), calculated from the microCT reconstructions of the bone core biopsy samples. [Срок оценки: 3-6 months]
• Value of the Connectivity (Conn.), calculated from the microCT reconstructions of the bone core biopsy samples. [Срок оценки: 3-6 months]

Критерии участия

Критерии включения

• Patients over the age of 18 years,
• Patients who need dental implant-borne prostheses,
• Patients with insufficient bone height in the posterior maxilla due to sinus pneumatization.

Критерии исключения

.• Patients who had major systemic diseases as classified by the American Society of Anesthesiologists (ASA grades III-IV),

• psychiatric contraindications,
• patients on medication interfering with bone metabolism, including steroid therapy and antiresorptive medication,
• radiation to the head or neck region within the previous five years,
• localized periapical disease, odontogenic and nonodontogenic cysts, and maxillary sinusitis,
• evidence of uncontrolled periodontal disease,
• Alcohol Use Disorder defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5),
• recreational drug abuse,
• heavy smoking (>10 cigarettes/day),
• diseases of the oral mucosa, including blisters and ulcers, i.e.: red and white lesions, pigmented lesions, benign tumors of the oral cavity, and oral cancer. Leukoplakia, Erythroplakia, Precancerous lesions, Oral squamous cell carcinoma and malign tumors of the soft and hard tissues, Oral candidiasis, Oral lichen planus, Psoriasis, Pemphigus, and Pemphigoid.
• pregnancy or nursing,
• poor oral hygiene

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

Простое слепое

Основная цель

Лечение

Центры проведения

Венгрия · 1 центр

• Semmelweis University Department of Public Dental Health — Budapest

Идентификаторы

NCT: NCT06533397 · SEDCD44

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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