Evaluation Of The Success Rate of NOVAMag® SHIELD

ConditionsAlveolar Buccal Bone Dehiscences Socket Type 3 Subclass B Socket Type 3 Subclass C

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorEgas Moniz - Cooperativa de Ensino Superior, CRL

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

SHIELD technique with NOVAMag membrane
Procedure/Surgery
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: First group will include compromised sockets classified as ST3 Subclass BActive comparator 1 intervention

Group B: Second group will include compromised sockets classified as ST3 Subclass CActive comparator 1 intervention

Trial outcomes

Primary outcomes

Volumetric bone gain

The primary outcome of the study will be volumetric bone gain assessed via CBCT from baseline to the 3-4 month follow-up, while secondary outcomes will include membrane handling characteristics, resorption profile, soft tissue healing, and patient-reported outcomes.

Time frame

From enrollment to the follow-up consultation at 3 to 4 months

Sponsors and contacts

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Egas Moniz - Cooperativa de Ensino Superior, CRL

Lead sponsor

Botiss Biomaterials GmbH

Collaborator

Klockner Implant System

Collaborator

Source ClinicalTrials.gov

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