Three-dimensional Bone Regeneration Using Custom-made Meshes With and Without Collagen Membrane: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The rate of healing complications after reconstructive surgery
研究概览
简要总结
The presence of alveolar ridge deficiencies is considered major limitation to achieve an implant-prosthetic restoration with high aesthetics and stability over time. Guided Bone Regeneration (GBR) can be considered an effective solution for bone augmentation. The most advanced technology of GBR is the customized titanium mesh, which is developed with a fully digital work flow system. The aim of this study is to evaluate complications and bone augmentation rates after GBR, based on customized meshes with or without collagen membranes.
After ethical committee approval, 30 patients with horizontal and/or vertical bone defects were enrolled and treated according to the study protocol. During reconstructive surgery (T0), patients were randomly divided into two study groups: 15 patients were treated by means of a custom-made mesh without collagen membrane (Group A - Control Group), while 15 patients were treated by means of a custom-made titanium mesh with a collagen membrane (Group B - Test Group). All sites were grafted with a mixture 50:50 of autogenous bone and xenograft and primary closures of surgical sites were obtained to ensure a submerged healing of the meshes. After 6 months (T1), re-entry surgery was completed to remove the meshes, evaluate the augmented volume and to place implants in the augmented sites. After 3 months (T2), soft tissue management was accomplished with implant exposure and a connective tissue graft, before prosthetic restoration (T3). Data collection included surgical and healing complications, planned bone volume (PBV) and reconstructed bone volume (RBV), pseudo-periosteum type, bone density, implant success, and crestal bone loss. A statistical analysis of recorded data was performed to investigate any statistically significant differences between the study group and statistical significance was set at a=0.05.
详细描述
The rationale of the study is based on the fact that manual and intraoperative modeling of an osteosynthesis mesh is an employee operator and even in the case of very experienced operators it is always difficult, inaccurate and slow. The use of this pre-modeled and pre-fabricated custom-made mesh with bevel margins and three-dimensionally morphology adapted to the bone defect, would allow for a congruous bone regeneration reducing the operating times, the risks linked to the mesh trauma, and the discomfort for the patient. The collagen membrane in association with titanium, based on the principles of guided bone regeneration (GBR), would make it possible to increase bone gain and reduce the percentage of early and late exposure of the mesh.
This study aims to evaluate, in cases of maxillary and mandibular atrophies characterized by a vertical and / or horizontal resorption of the alveolar bone, the percentage of complications (intra- and post-operative) after bone regeneration using custom-made mesh with or without collagen membrane.
The primary objective of this study is to evaluate the non-inferiority of technique B (custom-made mesh - without membrane) compared to technique A (custom-made mesh - with membrane) in the incidence of complications.
Secondary objectives include evaluation of the missing bone volume (lacking bone volume or LBV), reconstructed bone volume (reconstructed bone volume or RBV) with respect to planned bone volume (planned bone volume or PBV), histological and histomorphometric analysis at the time removal of the mesh and peri-implant bone resorption, due to the functional loading of the implants, at 12 months of follow-up.
Other objectives include the qualitative evaluation of bone regeneration by histological and histomorphometric analysis upon removal of the mesh; and the evaluation of peri-implant bone resorption, due to the functional loading of the implants, at 12 months of follow-up.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Surgeon is masked until the envelope opening at the end of the surgery, just before surgery.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, over the age of 18, in good general health.
- •Patients with partial edentulism of the maxilla or mandible, with a 2mm minimum to a 12mm maximum vertical bone defect, which requires a three-dimensional bone regeneration intervention in order to have a fixed implant supported rehabilitation.
- •Obtaining informed consent for experimental treatment and processing the personal data.
排除标准
- •Poor oral hygiene,
- •Untreated periodontal disease
- •Smoking habit> 10 cigarettes / day;
- •Abuse of alcohol or drugs
- •Pregnancy
- •Patients with odontostomatological infections and / or systemic infections in progress;
- •Patient with uncontrolled diabetes mellitus or other metabolic diseases;
- •Patients with severe changes in liver and kidney function.
- •Patients with confirmed uncontrolled autoimmune disorders.
- •Patients subjected radiation therapy in the head or neck region in the last 5 years.
- •Patients undergoing immunosuppressive and / or immunocompromised therapy
结局指标
主要结局
The rate of healing complications after reconstructive surgery
时间窗: 6 months
Healing complications are evaluated based on the chronological order in which they occur: * immediate exposure occurs within the 1st month * early exposure occurs between the 1st and the 3rd month * late exposure occurs after the 3rd month Evaluation of low-grade and high-grade infection of medical devices used for bone regeneration. The former complications are classified as: * Class A, including flap damage (soft tissue perforation or laceration) * Class B, including neurological damage (paresthesia or disesthesia) * Class C,including vascular damage (hemorrhage). The latter complications are divided into four classes, according to the presence and extent of exposure, as well as the presence of a purulent exudate: * Class I, membrane exposure \<3 mm, no purulent exudate * Class II membrane exposure \>=3mm, no purulent exudate * Class III: membrane exposure, with purulent exudate
次要结局
- Dosage of painkillers(Post operative from immediately after surgery to the 14th day after the surgery)
- Discomfort level of the patient using a Post-operative Symptom Severity (PoSSe)(Post operative, measured on 14th day after the surgery])
- Level of satisfaction of the patient using a Health-Related Quality of Life (HrQoL)(6 months and 12 months after the dental prosthesis dental prosthesis has been placed.)
- Time required for the CBCT analysis and design of the medical device(Pre-operative, 2 weeks before the day of the surgery)
- Total operative time required for the surgery, measured from immediately before to immediately after the surgery.(During procedure)
- Level of operator satisfaction Measured on a 5 point scale(Immediately after the surgery)
- Level of anxiety of the patient measured with a Visual Analogue Scale (VAS)(Immediately before/after surgery)
- Costs related to the technique(Immediately after the surgery)
- Operator anxiety level recorded on a Visual Analogue Scale (VAS)(From 3 days before the surgery to immediately before the surgery, during the intervention and at the 14th day after the surgery.)
- Pain level of the patient measured on a Visual Analogue Scale (VAS)(Post operative from immediately after surgery to the 14th day after the surgery)
- Total Number of painkillers taken post-operative(Post operative from immediately after surgery to the 14th day after the surgery)
- Number of patients' post-operative signs and symptoms(From the 1st day to the 14th day after the surgery.)
- Willingness of the patient to undergo the intervention recorded on a Visual Analogue Scale (VAS)(Post operative measured on the 7th day and on the 14th day)
- Total chair time measured from immediately before the surgery to immediately after the surgery.(During procedure)
- Limitation in daily functions measured on a Visual Analogue Scale (VAS)(Post operative from immediately after surgery to the 14th day after the surgery)
- Level of operator confidence with the technique(During procedure)
研究者
Alessandro Cucchi
Principal Investigator
GBR Academy