Maxillary Sinus Floor Augmentation With a 1:1 Mixture of Autogenous Bone Graft and Symbios Xenograft Granules Compared With Blood Coagulum. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Survival of suprastructures
研究概览
简要总结
Implant placement in posterior maxilla is often compromised or impossible due to atrophy of the bone and pneumatisation of the maxillary sinus. Thus, alveolar ridge augmentation is frequently necessary. The most commonly used method to augment the maxillary region involves the maxillary sinus floor augmentation (MSFA) with autogenous bone graft or bone substitute. Harvesting of autogenous bone graft is associated with risk of donor site morbidity and unpredictable resorption of the graft. Thus, bone substitutes alone or in combination with autogenous bone are used increasingly.
Symbios xenograft granules is a new porcine bone mineral. Long-term studies have demonstrated that xenograft contains osteoconductive properties and is a safe grafting material. MSFA with xenograft alone or in combination with autogenous bone have shown high implant survival with new bone formation. In contrast, the maxillary sinus cavities possess significant potential for bone regeneration without the use of additional bone grafts or bone substitutes due to the principle of periosteal guided bone regeneration and surrounding bony walls. Bone regeneration after maxillary sinus membrane elevation with the use of coagulum as grafting material has shown high implant survival with new bone formation, as documented in reviews and short-term studies.
The objective is to test the H0-hypothesis of no difference in the long-term implant outcome after MSFA with 1:1 mixture of autogenous bone graft and Symbios xenograft (control) compared with the coagulum (test). Forty consecutively healthy patients with a missing posterior maxillary tooth will be allocated to test or control. Implants will be inserted simultaneously with the MSFA. Clinical and/or radiographical evaluation using periapical radiographs and Cone Beam Computer Tomography (CBCT) will be performed preoperatively, immediate postoperatively, before abutment connection, after prosthetic rehabilitation, and one year after loading to assess the implant treatment outcome and the volumetric changes of the augmented area. The primary outcome will include survival of suprastructures, survival of implants, volumetric stability of the augmented area, peri-implant marginal bone level, oral health related quality of life, and complications related to the two treatment modalities.
详细描述
Maxillary sinus floor augmentation (MSFA) is used to enhance the alveolar bone height of the posterior maxilla. Autogenous bone is the preferred graft material. Dental implants inserted in sinuses augmented with autogenous bone grafts have demonstrated high implant survival. However, autogenous bone grafts is associated with risk of donor site morbidity and unpredictable graft resorption. Hence, various bone substitutes alone or in combination with autogenous bone graft are used to simplify the surgical procedure by diminishing the need for bone harvesting. Reviews have reported high survival of suprastructures and implants after MSFA with different mixtures of autogenous bone graft and bone substitutes. Xenograft is a tissue graft transplanted from another species than humans. MSFA with xenograft alone or in combination with autogenous bone graft have demonstrated high survival of suprastructures and implants. Symbios xenograft granules (Dentsply, United Kingdom) is a new porcine bone mineral characterized as an anorganic bone matrix with an interconnecting pore structure that supports formation and in-growth of new bone. A short-term study comparing autogenous bone graft with porcine bone alone or a mixture of autogenous bone and porcine bone indicated that porcine bone alone or in combination with autologous bone is biocompatible and osteoconductive and can be successfully used for MSFA. However, the long-term implant survival after MSFA with autogenous bone graft in combination with Symbios xenograft granules is presently unknown. In contrast, it has been postulated that bone formation in the maxillary sinus does not require the presence of a grafting material. The maintenance of space for blood clot formation accompanied by the resorption and deposition of bone cells derived from the sinus periosteum or cancellous bone of the maxilla would be responsible for bone formation. Moreover, high implant survival rate, limited peri-implant marginal bone loss, few biological and technical complications has been documented after MSFA with blood coagulum as grafting material. However, only few short-term studies have compared MSFA with blood coagulum and autogenous bone graft or bone substitutes. Therefore, it is presently unknown how much bone regeneration and grafting is necessary for long-term functional implant stability after MSFA.
Purpose Test the H0-hypothesis of no difference in implant treatment outcome after MSFA with a 1:1 mixture of autogenous bone graft and Symbios xenograft granules compared with blood coagulum as grafting material. Assessment will include survival of suprastructures and implants, changes in peri-implant marginal bone level, volumetrical stability of the graft material and treatment related complications after an observation period of one year. Oral health related quality of life (OHIP-14) and patient satisfaction will also be assessed using questionnaire and visual analogue scales (VAS).
Objective
Test the H0 hypothesis of no differences in:
- Survival of suprastructures and implants.
- Volumetrical stability of the graft.
- Peri-implant marginal bone level.
- Implantat stability quotient.
- Patient-reported outcome measures.
- Complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Blinded
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥20 years.
- •Missing one posterior maxillary tooth.
- •Residual bone height of the maxillary alveolar process ≥4-7 mm≤.
- •Width of the alveolar process ≥6.5 mm.
- •Mandibular occluding teeth.
排除标准
- •Contraindications to implant therapy.
- •Full mouth plaque score >25%.
- •Progressive marginal periodontitis.
- •Acute infection in the area intended for implant placement.
- •Parafunction, bruxism, or clenching.
- •Psychiatric problems or unrealistic expectations.
- •Heavy tobacco use, define as >10 cigarettes per day.
- •Pregnancy.
结局指标
主要结局
Survival of suprastructures
时间窗: After one year of functional loading
Loss of suprastructures is defined as a total loss because of a non-treatable mechanical/or biological complication
Survival of implants
时间窗: After one year of functional loading
Loss of implants is defined as removal of a non-integrated implant, mobility of previously clinical osseointegrated implant, and removal of non-mobile implants due to progressive peri-implant marginal bone loss and infection
次要结局
- Volumetric changes of the graft material(One year after sinus floor elevation and augmentation)
- Peri-implant marginal bone level(One year of functional loading)
研究者
Thomas Starch-Jensen
Professor, DDS, PhD
Aalborg University Hospital