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NCT07533110: NOVASHIELD-RCT

Evaluation Of The Success Rate of NOVAMag® SHIELD In Two Different Advanced Bone Defects: A Randomized Controlled Trial

Recruiting now Phase 4 Last updated 16 April 2026
What this trial tests

Phase 4 trial testing SHIELD technique with NOVAMag membrane in Alveolar Buccal Bone Dehiscences in 40 participants. Currently enrolling.

Timeline
19 March 2026
Primary endpoint
18 December 2026
30 September 2027

Quick facts

Lead sponsorEgas Moniz - Cooperativa de Ensino Superior, CRL
PhasePhase 4
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment40
Start date19 March 2026
Primary completion18 December 2026
Estimated completion30 September 2027
Sites1 location across Portugal

Drugs / interventions tested

Conditions studied

Sponsor

Egas Moniz - Cooperativa de Ensino Superior, CRL — full company profile →

Who can join

Eligibility, any sex, with Alveolar Buccal Bone Dehiscences or Socket Type 3 Subclass B. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Egas Moniz - Cooperativa de Ensino Superior, CRL trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07533110.

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