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RECRUITING
NCT07533110
PHASE4

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

Sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRL

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-03-19

Completion Date

2027-09-30

Last Updated

2026-04-16

Healthy Volunteers

No

Interventions

PROCEDURE

SHIELD technique with NOVAMag membrane

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)

Clinica Dentaria Egas Moniz

Almada, Setúbal District, Portugal