Evaluation Of The Success Rate of NOVAMag® SHIELD (NCT07533110) | Clinical Trial Compass
RecruitingPhase 4
Evaluation Of The Success Rate of NOVAMag® SHIELD
Portugal40 participantsStarted 2026-03-19
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Volumetric bone gain
Timeframe: From enrollment to the follow-up consultation at 3 to 4 months
Trial details
NCT IDNCT07533110
SponsorEgas Moniz - Cooperativa de Ensino Superior, CRL