Evaluation Of The Success Rate of NOVAMag® SHIELD In Two Different Advanced Bone Defects: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Volumetric bone gain
研究概览
简要总结
This study hypothesizes that the SHIELD technique, when combined with a suitable bone graft material, enables successful immediate implant placement in Type 3 extraction sockets with buccal bone dehiscence, regardless of the extent of buccal bone loss. Specifically, it is proposed that the regenerative potential of the SHIELD technique is not significantly affected by the degree of buccal bone dehiscence, whether in compromised sockets (ST3 Subclass B, when a buccal dehiscence is present and extending 1/3 to 2/3 of the total length of the alveolus) or severely compromised sockets (ST3 Subclass C, for severe dehiscence passing more than 2/3 of the facial bone of the alveolus). All in all, this study aims to assess the clinical performance of the CE-approved medical device NOVAMag® SHIELD by evaluating its success rate and long-term suitability for the rehabilitation of edentulous regions in routine clinical settings. It further seeks to generate clinically meaningful evidence supporting the safety and efficacy of magnesium-based biomaterials in the management of complex post-extraction defects. In addition, the study investigates the CE-approved self-tapping conical implant VEGA® + to obtain comprehensive clinical data contributing to post-market surveillance and continuous product evaluation.
详细描述
This prospective, controlled observational clinical study aims to evaluate the clinical and radiographic outcomes of bone regeneration using the SHIELD Technique with the NOVAMag® membrane XS (SHIELD) in 40 patients of the periodontology department requiring regenerative treatment in the aesthetic region.
Patients will be stratified into two groups of 20 individuals each, based on the condition of the extraction socket. The first group will include compromised sockets classified as ST3 Subclass B, in which a buccal dehiscence extends from one-third to two-thirds of the total length of the alveolus, while the second group will comprise severely compromised sockets classified as ST3 Subclass C, in which the dehiscence extends over two-thirds of the facial bone of the alveolus.
In both groups, cerabone plus (a bovine bone substitute mixed with hyaluronic acid) will be used as the grafting material. In all patients, the CE-approved self-tapping conical implant VEGA® + will be immediately placed, allowing the study to obtain comprehensive clinical data contributing to post-market surveillance and continuous product evaluation.
All procedures will adhere to established ethical standards, including data protection (all patient data will be anonymized prior to collection to ensure confidentiality), informed consent, and rigorous clinical follow-up, ensuring that the study provides reliable and clinically relevant evidence on the performance of magnesium-based membranes in the management of complex post-extraction defects, as well as the clinical performance of immediately placed VEGA® + implants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older;
- •Willingness and ability to provide informed consent and accept participation in the study.
- •Presence of a tooth indicated for extraction in the aesthetic zone (including premolars);
- •Clinical indication for immediate implant placement following tooth extraction;
- •Extraction sockets classified as Socket Type 3 (ST3), Subclass B or C, according to the Steigmann (2022) classification;
排除标准
- •Pregnancy or lactating women;
- •Systemic diseases or conditions known to affect bone metabolism (osteoporosis, uncontrolled diabetes, metabolic bone disorders, chronic corticosteroid therapy, etc.);
- •Active infection at the surgical site, including the presence of an acute abscess or other signs of ongoing local infection;
- •Hypersensitivity to the biomaterials intended for use in the regenerative procedure.
研究组 & 干预措施
First group will include compromised sockets classified as ST3 Subclass B
The first group will include compromised sockets classified as ST3 Subclass B, in which a buccal dehiscence extends from one-third to two-thirds of the total length of the alveolus
干预措施: SHIELD technique with NOVAMag membrane (Procedure)
Second group will include compromised sockets classified as ST3 Subclass C
The second group will comprise severely compromised sockets classified as ST3 Subclass C, in which the dehiscence extends over two-thirds of the facial bone of the alveolus.
干预措施: SHIELD technique with NOVAMag membrane (Procedure)
结局指标
主要结局
Volumetric bone gain
时间窗: From enrollment to the follow-up consultation at 3 to 4 months
The primary outcome of the study will be volumetric bone gain assessed via CBCT from baseline to the 3-4 month follow-up, while secondary outcomes will include membrane handling characteristics, resorption profile, soft tissue healing, and patient-reported outcomes.
次要结局
未报告次要终点