Evaluation Of The Success Rate of NOVAMag® SHIELD
Evaluation Of The Success Rate of NOVAMag® SHIELD In Two Different Advanced Bone Defects: A Randomized Controlled Trial
Egas Moniz - Cooperativa de Ensino Superior, CRL
40 participants
Mar 19, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria4
- 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.
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Interventions
The SHIELD technique with NOVAMag membrane will be performed and 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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07533110