Evaluation Of The Success Rate of NOVAMag® SHIELD (NOVASHIELD-RCT)

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

Study Overview

• Status: Recruiting
• Conditions: Alveolar Buccal Bone Dehiscences; Socket Type 3 Subclass B; Socket Type 3 Subclass C
• Intervention / Treatment: Procedure: SHIELD technique with NOVAMag membrane

Detailed Description

This prospective, controlled observational clinical study aims to evaluate the clinical and radiographic outcomes of bone regeneration using the SHIELD Technique with the NOVAMag® membrane XS (SHIELD) in 40 patients of the periodontology department requiring regenerative treatment in the aesthetic region.

Patients will be stratified into two groups of 20 individuals each, based on the condition of the extraction socket. The first group will include compromised sockets classified as ST3 Subclass B, in which a buccal dehiscence extends from one-third to two-thirds of the total length of the alveolus, while the second group will comprise severely compromised sockets classified as ST3 Subclass C, in which the dehiscence extends over two-thirds of the facial bone of the alveolus.

In both groups, 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.

All procedures will adhere to established ethical standards, including data protection (all patient data will be anonymized prior to collection to ensure confidentiality), informed consent, and rigorous clinical follow-up, ensuring that the study provides reliable and clinically relevant evidence on the performance of magnesium-based membranes in the management of complex post-extraction defects, as well as the clinical performance of immediately placed VEGA® + implants.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Patrícia Lyra, PhD; Phone Number: 212 946 700; Email: plyra@egasmoniz.edu.pt
• Study Contact Backup: Name: João Botelho, PhD; Phone Number: 212 946 700; Email: jbotelho@egasmoniz.edu.pt

Study Locations

• Portugal
  • Setúbal District
    • Almada, Setúbal District, Portugal, 2829-511
      • Recruiting
      • Clinica Dentaria Egas Moniz
      • Contact: Patricia Lyra, PhD; Phone Number: 212946806; Email: plyra@egasmoniz.edu.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: First group will include compromised sockets classified as ST3 Subclass B; The first group will include compromised sockets classified as ST3 Subclass B, in which a buccal dehiscence extends from one-third to two-thirds of the total length of the alveolus	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.
Active Comparator: Second group will include compromised sockets classified as ST3 Subclass C; The second group will comprise severely compromised sockets classified as ST3 Subclass C, in which the dehiscence extends over two-thirds of the facial bone of the alveolus.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the follow-up consultation at 3 to 4 months

Collaborators and Investigators

• Sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRL
• Collaborators: Klockner Implant System; Botiss Biomaterials GmbH
• Investigators: Principal Investigator: Patrícia Lyra, PhD, Egas Moniz School of Health & Science; Principal Investigator: João Botelho, PhD, Egas Moniz School of Health & Science

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2026
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Socket Shield Technique; Immediate Implant Placement; Magnesium Membrane; Buccal Bone Dehiscence
• Other Study ID Numbers: 1793

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to ethical and regulatory reasons IPD won't be possible

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No