MedTrace Logo

Evaluation Of The Success Rate of NOVAMag® SHIELD

NCT07533110 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Alveolar Buccal Bone Dehiscences
  • Socket Type 3 Subclass B
  • Socket Type 3 Subclass C

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.

Sponsors & Collaborators

  • Botiss Biomaterials GmbH

    collaborator INDUSTRY

  • Klockner Implant System

    collaborator UNKNOWN

  • Egas Moniz - Cooperativa de Ensino Superior, CRL

    lead OTHER

Principal Investigators

  • Patrícia Lyra, PhD · Egas Moniz School of Health & Science

  • João Botelho, PhD · Egas Moniz School of Health & Science

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-19
Primary Completion
2026-12-18
Completion
2027-09-30

Countries

  • Portugal

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07533110 on ClinicalTrials.gov