Reinforced PTFE Meshes Versus Customized Titanium Meshes: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 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 objective of this study is to compare two surgical techniques for the treatment of the maxillary and mandibular bone atrophies.. Therefore, the main purpose is to compare the (i) the percentage of post-operative complications (ii) the three-dimensional bone gain with customized titanium meshes (test group - the medical device is digitally designed and made with customized laser sintering modality, customized to the defect of each patient) and with titanium-reinforced PTFE mesh (control group - the medical device is cut, shaped, and manually modelled to the patient's defect by the operator himself.
详细描述
The rationale of the study is based on the fact that manual intra-operative modelling of a titanium-reinforced PTFE mesh is operator-dependent, and even in the case of very experienced operators it is always difficult, inaccurate and slow. The use of pre-modelled and pre-fabricated custom-made meshes with bevel margins and three-dimensional morphology adapted to the bone defect, would make it possible to carry out an important bone regeneration as it reduces the operating times, the risks linked to mesh borders, trauma to the soft tissues and the discomfort for the patient.
This study aims to evaluate, in cases of maxillary and mandibular atrophies characterized by a vertical and / or combined resorption of the alveolar bone, the complication rate (intra- and post-operative) and the three-dimensional bone gain after traditional bone regeneration, where the medical device necessary for bone regeneration is cut out, shaped, and manually modelled by the operator, compared to digital bone regeneration. Subsequently, the medical device is digitally designed and made with a computerized method.
The primary objective of the study is, therefore, the evaluation of the healing complications; in particular, the early or delayed exposure of medical devices used for bone regeneration, during the healing period. This exposure is, as reported in all clinical studies, the main cause of the failure of the surgery.
A secondary objective, is the quantitative assessment of bone regeneration obtained by the 2 techniques. In particular, the evaluation of the reconstructed bone volume (RBV) with respect to the planned bone volume (PBV).
Other targets include the qualitative evaluation of bone regeneration through histological and histomorphometric analysis of the bone biopsies obtained at the moment that the medical device is removed and finally the evaluation of the peri-implant bone resorption will be conducted over time.
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
The surgeon is masked until the envelope is opened at the time of the surgery.
入排标准
- 年龄范围
- 18 Years 至 —（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.
研究组 & 干预措施
Group A - control group
25 patients will undergo bone regeneration with a titanium reinforced PTFE Mesh (RPM - Osteogenics Lubbock Texas USA), manually shaped and modeled by the operator during surgery (traditional technique), covered with collagen membranes of medium-rapid resorption (Vitala - Osteogenics Lubbock Texas USA)
干预措施: RPM - Osteogenics Lubbock Texas USA (Device)
Group B - Test group
25 patients undergo bone regeneration with a custom-made titanium mesh (Yxoss CBR - Reoss Filderstadt Germany), digitally designed by an operator before the surgery (digital technique), covered by collagen membranes with medium-rapid resorption (Bio-Gide - Geistlich Baden Baden Germany)
干预措施: Yxoss CBR - Reoss Filderstadt Germany (Device)
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 between 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.)
- Number of patients' post-operative signs and symptoms(Post operative from immediately after surgery to the 14th day after the surgery.)
- Level of satisfaction of the patient using a Health-Related Quality of Life (HrQoL)(Post operative, 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)
- 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 anxiety of the patient measured with a Visual Analogue Scale (VAS)(Immediately before/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 operative time required for the surgery measured from immediately before to immediately after the surgery.(During procedure)
- Discomfort level of the patient using a Post-operative Symptom Severity (PoSSe)(Post operative, measured on 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.)
- Level of operator satisfaction Measured on a 5 point scale(Immediately after the surgery)
- Costs related to the technique(Immediately after surgery)
- Total Number of painkillers taken post-operative(Post operative from immediately after surgery to the 14th day 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)
- Total chair time measured from immediately before the surgery to immediately after the surgery.(During procedure)
- Level of operator confidence with the technique(During procedure)
研究者
Alessandro Cucchi
Principal Investigator
GBR Academy