Evaluation Of The Success Rate of NOVAMag® SHIELD

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.

Inclusion criteria

• 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;

Exclusion criteria

• 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.