Actively Recruiting
Evaluation Of The Success Rate of NOVAMag® SHIELD
Led by Egas Moniz - Cooperativa de Ensino Superior, CRL · Updated on 2026-04-21
40
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
Sponsors
E
Egas Moniz - Cooperativa de Ensino Superior, CRL
Lead Sponsor
B
Botiss Biomaterials GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation Of The Success Rate of NOVAMag® SHIELD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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;
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Clinica Dentaria Egas Moniz
Almada, Setúbal District, Portugal, 2829-511
Actively Recruiting
Research Team
P
Patrícia Lyra, PhD
CONTACT
J
João Botelho, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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